<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02997423</url>
  </required_header>
  <id_info>
    <org_study_id>NN106</org_study_id>
    <secondary_id>U01NS093663</secondary_id>
    <nct_id>NCT02997423</nct_id>
  </id_info>
  <brief_title>Cytochrome C Oxidase Activity in Newly Diagnosed Glioblastoma Multiforme (GBM)</brief_title>
  <official_title>Prospective Phase II Study of Cytochrome C Oxidase Activity as a Novel Biomarker In Subjects With Newly Diagnosed Primary Glioblastoma Multiforme</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>NeuroNEXT Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-institutional, consortium-based, non-interventional prospective blinded&#xD;
      endpoints clinical study to determine whether high activity of Cytochrome C Oxidase (CcO) in&#xD;
      tumor specimens from subjects with newly diagnosed primary GBM is associated with shortened&#xD;
      OS (primary outcome) and PFS (secondary outcome) times.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Biomarker trial is designed to prospectively evaluate the hypothesis that the overall&#xD;
      survival (OS) time of a subject with newly diagnosed primary GBM tumors, treated by standard&#xD;
      of care (SOC), is a function of the CcO enzymatic activity in the tumor (OS; time interval&#xD;
      from date of first diagnosis to death from any cause, irrespective of post-SOC therapies,&#xD;
      assessed up to 24 months from accrual). In particular, tumors with high CcO activity are&#xD;
      associated with shorter OS time as compared to tumors with low CcO activity. SOC consists of&#xD;
      post-surgical radiation therapy with concurrent Temozolomide followed by up to 12 cycles of&#xD;
      adjuvant Temozolomide.&#xD;
&#xD;
      Additional outcomes are to study the relation between CcO activity in the GBM tumors and&#xD;
      progression free survival times (PFS; time intervals from dates of diagnosis to documented&#xD;
      disease progression by MRI or tumor-related death) and, to compare the prognostic abilities&#xD;
      of CcO activity to other frequently used biomarkers, namely the methylation status of&#xD;
      O6-methylguanine-DNA methyltransferase (MGMT), on OS and PFS.&#xD;
&#xD;
      Tumor tissue will be submitted by participating centers for measurements of the CcO/Citrate&#xD;
      Synthase (CS), MGMT promoter methylation. The subjects will agree to receive the SOC&#xD;
      treatment. The therapeutic option at the time of first recurrence is at the discretion of the&#xD;
      treating physician. PFS and OS times will be compared with high vs. low CcO activity and with&#xD;
      the MGMT methylation status of the tumor. At the time of death or at 24 months s/p enrollment&#xD;
      (whichever comes first), the site PI will complete an exit form documenting the details of&#xD;
      enrollees' treatment history and date(s) of any tumor progression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2016</start_date>
  <completion_date type="Actual">November 30, 2022</completion_date>
  <primary_completion_date type="Actual">November 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Date of diagnosis through 24 months after enrollment</time_frame>
    <description>This biomarker trial is designed to prospectively evaluate the hypothesis that the overall survival (OS) time of a subject with newly diagnosed primary GBM tumors, treated by standard of care (SOC), is a function of the CcO enzymatic activity in the tumor. OS is defined as the time interval from date of first diagnosis to death from any cause, irrespective of post-SOC therapies, assessed up to 24 months from accrual.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>Date of diagnosis through 48 months after enrollment</time_frame>
    <description>This biomarker trial is designed to prospectively evaluate the hypothesis that progression free survival time (PFS) is a function of the CcO enzymatic activity in the tumor. PFS is defined as time interval from date of surgery to first documented progression according to the RANO criteria, irrespective of post-SOC therapies.</description>
  </other_outcome>
  <other_outcome>
    <measure>MGMT methylation status on OS and PFS</measure>
    <time_frame>Date of diagnosis through 24 months after enrollment</time_frame>
    <description>Compare the prognostic abilities of CcO activity to another frequently used biomarker, the methylation status of O6-methylguanine-DNA methyltransferase (MGMT) on OS and PFS times.</description>
  </other_outcome>
  <enrollment type="Actual">153</enrollment>
  <condition>Glioblastoma</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumor tissue and DNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Newly diagnosed primary Glioblastoma multiforme (GBM) patients who will receive standard of&#xD;
        care treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Willingness and ability to provide written informed consent and to comply with the&#xD;
             study protocol as judged by Physician interview (NOTE: This could be patient's&#xD;
             Neurosurgeon, Neuro-Oncologist or Study Investigator). If patient lacks capacity to&#xD;
             consent, a legally authorized representative is allowed to provide written informed&#xD;
             consent.&#xD;
&#xD;
          2. Age ≥ 21 years&#xD;
&#xD;
          3. Karnofsky Performance Status (KPS) ≥ 60.&#xD;
&#xD;
          4. Subjects' planned upfront treatment to be standard of care treatment with radiotherapy&#xD;
             and temozolomide (i.e. TEMODAR) for histologically confirmed GBM at initial diagnosis&#xD;
&#xD;
          5. No history of other malignancies except adequately treated non-melanoma skin cancer,&#xD;
             curatively treated in situ cancer of the cervix, or other curatively treated solid&#xD;
             tumors with no evidence of disease for at least 5 years.&#xD;
&#xD;
          6. No serious active infection (e.g., wound infection requiring parenteral antibiotics)&#xD;
             or other serious underlying medical conditions that in the opinion of the investigator&#xD;
             would compromise standard of care treatment.&#xD;
&#xD;
          7. No other condition (e.g., psychological or geographical) that would preclude study&#xD;
             compliance.&#xD;
&#xD;
          8. An MRI that is consistent with a primary malignant glioma&#xD;
&#xD;
          9. Histologically confirmed newly diagnosed primary GBM before treatment using World&#xD;
             Health Organization (WHO) classification criteria (A local pathology report&#xD;
             constitutes adequate documentation of histology for initial study enrollment, however&#xD;
             central pathology review will be required to confirm the diagnosis of GBM for final&#xD;
             data analysis).&#xD;
&#xD;
         10. Viability of tumor tissue representative of GBM ≥ 70 mg, snap-frozen within 30 minutes&#xD;
             of resection, 10 minutes or less at room temperature.&#xD;
&#xD;
         11. All subjects must have received maximal safe resection followed by standard radiation&#xD;
             therapy with concomitant Temozolomide taken during the course of radiation therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria are proposed that will exclude subjects with pre-existing co-morbidities&#xD;
        that could contribute to pre-mature death (e.g., significant cardiovascular history), with&#xD;
        non-included pretreated tumors occupying either intracranial and extra-axial space,&#xD;
        significantly impaired neurological performance status (e.g., KPS&gt;60), with glial tumors&#xD;
        that are genomically distinct from primary GBM tumors (e.g., gliomas arising from a&#xD;
        previously diagnosed lower grade than GBM) or those unable to complete the fundamental&#xD;
        requirements of the study.&#xD;
&#xD;
          1. Inability to fulfill the requirements of the protocol&#xD;
&#xD;
          2. Secondary GBM or other gliomas.&#xD;
&#xD;
          3. History of sensitivity to Temozolomide.&#xD;
&#xD;
          4. Planned upfront treatment with any anti-angiogenic agent targeting the (vascular&#xD;
             endothelial growth factor (VEGF) pathway including but not limited to bevacizumab,&#xD;
             cediranib, vandetanib, sunitinib, pazopanib, aflibercept, or sorafenib or any&#xD;
             immunotherapy regimen.&#xD;
&#xD;
          5. Any severe post-operative infection or other complications that may significantly&#xD;
             delay the initiation of brain tumor therapy, or other conditions that, in the opinion&#xD;
             of the investigator, would compromise the subject's ability to participate in the&#xD;
             study.&#xD;
&#xD;
        Note: Use of Gliadel wafers, in combination with surgical resection, is allowed if the&#xD;
        patient is to follow standard-of-care treatment post-operatively (i.e., radiation therapy&#xD;
        with temozolomide). Use of Gliadel wafers during surgery with only radiation therapy&#xD;
        post-operatively is excluded (i.e., omitting temozolomide).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Corinne E Griguer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University Medical School</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUNY Stony Brook</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15261</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Neuroscience Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Vogelbaum MA, Jost S, Aghi MK, Heimberger AB, Sampson JH, Wen PY, Macdonald DR, Van den Bent MJ, Chang SM. Application of novel response/progression measures for surgically delivered therapies for gliomas: Response Assessment in Neuro-Oncology (RANO) Working Group. Neurosurgery. 2012 Jan;70(1):234-43; discussion 243-4. doi: 10.1227/NEU.0b013e318223f5a7.</citation>
    <PMID>21593697</PMID>
  </reference>
  <reference>
    <citation>Galanis E, Wu W, Cloughesy T, Lamborn K, Mann B, Wen PY, Reardon DA, Wick W, Macdonald D, Armstrong TS, Weller M, Vogelbaum M, Colman H, Sargent DJ, van den Bent MJ, Gilbert M, Chang S. Phase 2 trial design in neuro-oncology revisited: a report from the RANO group. Lancet Oncol. 2012 May;13(5):e196-204. doi: 10.1016/S1470-2045(11)70406-5.</citation>
    <PMID>22554547</PMID>
  </reference>
  <results_reference>
    <citation>Griguer CE, Oliva CR, Coffey CS, Cudkowicz ME, Conwit RA, Gudjonsdottir AL, Ecklund DJ, Fedler JK, Neill-Hudson TM, Nabors LB, Benge M, Hackney JR, Chase M, Leonard TP, Patel T, Colman H, de la Fuente M, Chaudhary R, Marder K, Kreisl T, Mohile N, Chheda MG, McNeill K, Kumthekar P, Dogan A, Drappatz J, Puduvalli V, Kowalska A, Graber J, Gerstner E, Clark S, Salacz M, Markert J. Prospective biomarker study in newly diagnosed glioblastoma: Cyto-C clinical trial. Neurooncol Adv. 2021 Dec 24;4(1):vdab186. doi: 10.1093/noajnl/vdab186. eCollection 2022 Jan-Dec.</citation>
    <PMID>35088051</PMID>
  </results_reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Corinne Griguer</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Glioblastoma Multiforme</keyword>
  <keyword>Biomarker</keyword>
  <keyword>Cytochrome C Oxidase</keyword>
  <keyword>Newly diagnosed</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The requestor must submit a formal written request for data sharing, and the request must be approved by the NeuroNEXT Steering Committee and the Publication Committee before any data are shared. Prior to data sharing, the DCC and the external source must also execute a data sharing agreement that includes a description of the data that are requested and how the data will be shared. A contract / usage agreement may be required.&#xD;
The DCC will submit de-identified datasets and associated documentation to NINDS for archiving and public access, consistent with the current NINDS Data Sharing policy. The DCC will provide documentation with each final dataset to ensure that other users can efficiently and accurately use the dataset, and to prevent misinterpretation or misuse. This documentation may include information about how the data were collected, provide details about the code used to generate the dataset, and define variables and variable field locations.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Upon request.</ipd_time_frame>
    <ipd_access_criteria>Written request to principal investigator.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02997423
org study id: NN106
secondary id: U01NS093663
nct id: NCT02997423
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multi-institutional, consortium-based, non-interventional prospective blinded
      endpoints clinical study to determine whether high activity of Cytochrome C Oxidase (CcO) in
      tumor specimens from subjects with newly diagnosed primary GBM is associated with shortened
      OS (primary outcome) and PFS (secondary outcome) times.
This Biomarker trial is designed to prospectively evaluate the hypothesis that the overall
      survival (OS) time of a subject with newly diagnosed primary GBM tumors, treated by standard
      of care (SOC), is a function of the CcO enzymatic activity in the tumor (OS; time interval
      from date of first diagnosis to death from any cause, irrespective of post-SOC therapies,
      assessed up to 24 months from accrual). In particular, tumors with high CcO activity are
      associated with shorter OS time as compared to tumors with low CcO activity. SOC consists of
      post-surgical radiation therapy with concurrent Temozolomide followed by up to 12 cycles of
      adjuvant Temozolomide.

      Additional outcomes are to study the relation between CcO activity in the GBM tumors and
      progression free survival times (PFS; time intervals from dates of diagnosis to documented
      disease progression by MRI or tumor-related death) and, to compare the prognostic abilities
      of CcO activity to other frequently used biomarkers, namely the methylation status of
      O6-methylguanine-DNA methyltransferase (MGMT), on OS and PFS.

      Tumor tissue will be submitted by participating centers for measurements of the CcO/Citrate
      Synthase (CS), MGMT promoter methylation. The subjects will agree to receive the SOC
      treatment. The therapeutic option at the time of first recurrence is at the discretion of the
      treating physician. PFS and OS times will be compared with high vs. low CcO activity and with
      the MGMT methylation status of the tumor. At the time of death or at 24 months s/p enrollment
      (whichever comes first), the site PI will complete an exit form documenting the details of
      enrollees' treatment history and date(s) of any tumor progression.
observational model: Cohort
time perspective: Prospective
measure: Overall Survival (OS)
time frame: Date of diagnosis through 24 months after enrollment
description: This biomarker trial is designed to prospectively evaluate the hypothesis that the overall survival (OS) time of a subject with newly diagnosed primary GBM tumors, treated by standard of care (SOC), is a function of the CcO enzymatic activity in the tumor. OS is defined as the time interval from date of first diagnosis to death from any cause, irrespective of post-SOC therapies, assessed up to 24 months from accrual.
measure: Progression Free Survival (PFS)
time frame: Date of diagnosis through 48 months after enrollment
description: This biomarker trial is designed to prospectively evaluate the hypothesis that progression free survival time (PFS) is a function of the CcO enzymatic activity in the tumor. PFS is defined as time interval from date of surgery to first documented progression according to the RANO criteria, irrespective of post-SOC therapies.
measure: MGMT methylation status on OS and PFS
time frame: Date of diagnosis through 24 months after enrollment
description: Compare the prognostic abilities of CcO activity to another frequently used biomarker, the methylation status of O6-methylguanine-DNA methyltransferase (MGMT) on OS and PFS times.
Tumor tissue and DNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Corinne E Griguer, PhD
role: Principal Investigator
affiliation: University of Iowa
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Vogelbaum MA, Jost S, Aghi MK, Heimberger AB, Sampson JH, Wen PY, Macdonald DR, Van den Bent MJ, Chang SM. Application of novel response/progression measures for surgically delivered therapies for gliomas: Response Assessment in Neuro-Oncology (RANO) Working Group. Neurosurgery. 2012 Jan;70(1):234-43; discussion 243-4. doi: 10.1227/NEU.0b013e318223f5a7.
PMID: 21593697
citation: Galanis E, Wu W, Cloughesy T, Lamborn K, Mann B, Wen PY, Reardon DA, Wick W, Macdonald D, Armstrong TS, Weller M, Vogelbaum M, Colman H, Sargent DJ, van den Bent MJ, Gilbert M, Chang S. Phase 2 trial design in neuro-oncology revisited: a report from the RANO group. Lancet Oncol. 2012 May;13(5):e196-204. doi: 10.1016/S1470-2045(11)70406-5.
PMID: 22554547
citation: Griguer CE, Oliva CR, Coffey CS, Cudkowicz ME, Conwit RA, Gudjonsdottir AL, Ecklund DJ, Fedler JK, Neill-Hudson TM, Nabors LB, Benge M, Hackney JR, Chase M, Leonard TP, Patel T, Colman H, de la Fuente M, Chaudhary R, Marder K, Kreisl T, Mohile N, Chheda MG, McNeill K, Kumthekar P, Dogan A, Drappatz J, Puduvalli V, Kowalska A, Graber J, Gerstner E, Clark S, Salacz M, Markert J. Prospective biomarker study in newly diagnosed glioblastoma: Cyto-C clinical trial. Neurooncol Adv. 2021 Dec 24;4(1):vdab186. doi: 10.1093/noajnl/vdab186. eCollection 2022 Jan-Dec.
PMID: 35088051
responsible party type: Principal Investigator
investigator affiliation: University of Iowa
investigator full name: Corinne Griguer
investigator title: Associate Professor
mesh term: Glioblastoma
sharing ipd: Yes
ipd description: The requestor must submit a formal written request for data sharing, and the request must be approved by the NeuroNEXT Steering Committee and the Publication Committee before any data are shared. Prior to data sharing, the DCC and the external source must also execute a data sharing agreement that includes a description of the data that are requested and how the data will be shared. A contract / usage agreement may be required.
The DCC will submit de-identified datasets and associated documentation to NINDS for archiving and public access, consistent with the current NINDS Data Sharing policy. The DCC will provide documentation with each final dataset to ensure that other users can efficiently and accurately use the dataset, and to prevent misinterpretation or misuse. This documentation may include information about how the data were collected, provide details about the code used to generate the dataset, and define variables and variable field locations.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd time frame: Upon request.
ipd access criteria: Written request to principal investigator.