<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/NCT03269578</url>
  </required_header>
  <id_info>
    <org_study_id>170156</org_study_id>
    <secondary_id>17-C-0156</secondary_id>
    <nct_id>NCT03269578</nct_id>
  </id_info>
  <brief_title>Sample Collection and Tracking for the Developmental Therapeutics Clinic</brief_title>
  <official_title>Longitudinal Sample Collection and Tracking for the Developmental Therapeutics Clinic, National Cancer Institute</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      People who join a study in the Developmental Therapeutics Clinic (DTC) have tests. These&#xD;
      include blood draws and biopsies. Researchers collect data from these samples. Some people&#xD;
      take part in more than one study at the DTC. At this time, data are connected only with one&#xD;
      single study. Researchers want to access people s medical records. This will allow them to&#xD;
      link the research data from all their studies they have or will take part in. Researchers&#xD;
      also want to collect medical data about their diagnosis and treatment history. This will&#xD;
      allow them to see how their cancer reacted to different drugs over time.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To enter people into a master protocol to connect research sample and treatment data across&#xD;
      DTC studies.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      People ages 18 and older who are being evaluated or treated for cancer in the DTC&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will allow researchers to look at all the data from their research samples. This&#xD;
      includes those from their current, past, and any future NIH studies.&#xD;
&#xD;
      Participants will allow researchers to access some of their medical data. This includes age,&#xD;
      diagnosis, treatment history, and response to treatment.&#xD;
&#xD;
      Participants will provide no new samples.&#xD;
&#xD;
      ...&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Research samples and data collected on a treatment-intent protocol are discrete items&#xD;
      associated with that protocol up until the patient comes off study, usually due to disease&#xD;
      progression. These data are not stored in the patient s medical records, but are essential to&#xD;
      understand tumor response to different drugs over time. Patients in the Developmental&#xD;
      Therapeutics Clinic (DTC) often start other clinical trials; this protocol provides a&#xD;
      mechanism to connect research data about that patient from one trial to the next as long as&#xD;
      the patient remains eligible and has given his or her informed consent. No new analysis will&#xD;
      be performed under this protocol.&#xD;
&#xD;
      There is research interest in collecting pre- and post-dose research biopsies and other&#xD;
      samples such as circulating tumor cells to measure dynamic drug-specific target effects&#xD;
      (e.g., changes in epithelial-mesenchymal transition, DNA damage response, or&#xD;
      immunotherapeutic cell infiltration), and then to evaluate molecular changes before and&#xD;
      during disease progression to understand why the tumors initially respond but then became&#xD;
      resistant to treatment.&#xD;
&#xD;
      To accomplish this, we will connect research results from consecutive trials with limited&#xD;
      patient information (age, gender, disease, prior therapies, protocol number/drug regimen,&#xD;
      response, and duration of treatment).&#xD;
&#xD;
      Each patient who consents to participate in this non-treatment, longitudinal sample protocol&#xD;
      agrees to allow his or her Medical Record Number (MRN) to be used to track participation on&#xD;
      DTC clinical trials.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Patients will be entered onto this &quot;master&quot; longitudinal protocol to connect research sample&#xD;
      and treatment data across consecutive DTC clinical trials.&#xD;
&#xD;
      Biopsy samples collected at time of disease progression on one research trial will be&#xD;
      evaluated for use as the baseline sample for the next research trial, potentially obviating&#xD;
      the need for additional biopsies.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Adult patients who are being evaluated for and/or treated for cancer or benign tumors at the&#xD;
      DTC.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      No samples will be collected under this longitudinal protocol, no treatment decisions will be&#xD;
      made based on data collected, and no new analysis will be performed.&#xD;
&#xD;
      Specimens for research purposes, as outlined in this protocol, will be those obtained from&#xD;
      tests and procedures that are done as required by the primary research protocols that a given&#xD;
      patient is enrolled in. Tissue collected under DTC tissue procurement protocol 06-C-0213 will&#xD;
      not be used or tracked.&#xD;
&#xD;
      Sample location and use will be managed in the Repository at the Frederick National&#xD;
      Laboratory for Cancer Research using LabMatrix software.&#xD;
&#xD;
      Patients may remain on this longitudinal protocol for the duration of their consent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Anticipated">May 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 23, 2024</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Obtaining informed consent</measure>
    <time_frame>Time of enrollment</time_frame>
    <description>Collation of research sample and treatment data from individual patients across their participation in consecutive DTC clinical trials</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Neoplasms</condition>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>Patients with cancer or benign tumors being treated on NCI/DTC studies</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients on research protocols at the Developmental Therapeutics Clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Patients who are being evaluated and/or treated for cancer or benign tuumors in the&#xD;
             Developmental Therapeutics Clinic at the NIH Clinical Center&#xD;
&#xD;
          -  Ability to understand and willingness to sign a written informed consent document&#xD;
             indicating their willingness to have data from their tissue or biologic fluid research&#xD;
             specimens and limited medial information used for research as outlined in this&#xD;
             protocol and to allow protocol staff access to the CRIS database and their Medical&#xD;
             Records Number (MRN).&#xD;
&#xD;
          -  Age greater than or equal to 18 years&#xD;
&#xD;
        ECLUSION CRITERIA:&#xD;
&#xD;
        None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alice P Chen, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jennifer H Zlott</last_name>
    <phone>(240) 760-6046</phone>
    <email>zlottjh@mail.nih.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alice P Chen, M.D.</last_name>
    <phone>(240) 781-3320</phone>
    <email>chenali@mail.nih.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>For more information at the NIH Clinical Center contact National Cancer Institute Referral Office</last_name>
      <phone>888-624-1937</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-C-0156.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>September 13, 2023</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacodynamics</keyword>
  <keyword>Tissue Collection</keyword>
  <keyword>Tissue Biopsies</keyword>
  <keyword>Biospecimen</keyword>
  <keyword>Assay Development</keyword>
  <keyword>Natural History</keyword>
  <!-- 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/NCT03269578
org study id: 170156
secondary id: 17-C-0156
nct id: NCT03269578
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      People who join a study in the Developmental Therapeutics Clinic (DTC) have tests. These
      include blood draws and biopsies. Researchers collect data from these samples. Some people
      take part in more than one study at the DTC. At this time, data are connected only with one
      single study. Researchers want to access people s medical records. This will allow them to
      link the research data from all their studies they have or will take part in. Researchers
      also want to collect medical data about their diagnosis and treatment history. This will
      allow them to see how their cancer reacted to different drugs over time.

      Objective:

      To enter people into a master protocol to connect research sample and treatment data across
      DTC studies.

      Eligibility:

      People ages 18 and older who are being evaluated or treated for cancer in the DTC

      Design:

      Participants will allow researchers to look at all the data from their research samples. This
      includes those from their current, past, and any future NIH studies.

      Participants will allow researchers to access some of their medical data. This includes age,
      diagnosis, treatment history, and response to treatment.

      Participants will provide no new samples.

      ...
Background:

      Research samples and data collected on a treatment-intent protocol are discrete items
      associated with that protocol up until the patient comes off study, usually due to disease
      progression. These data are not stored in the patient s medical records, but are essential to
      understand tumor response to different drugs over time. Patients in the Developmental
      Therapeutics Clinic (DTC) often start other clinical trials; this protocol provides a
      mechanism to connect research data about that patient from one trial to the next as long as
      the patient remains eligible and has given his or her informed consent. No new analysis will
      be performed under this protocol.

      There is research interest in collecting pre- and post-dose research biopsies and other
      samples such as circulating tumor cells to measure dynamic drug-specific target effects
      (e.g., changes in epithelial-mesenchymal transition, DNA damage response, or
      immunotherapeutic cell infiltration), and then to evaluate molecular changes before and
      during disease progression to understand why the tumors initially respond but then became
      resistant to treatment.

      To accomplish this, we will connect research results from consecutive trials with limited
      patient information (age, gender, disease, prior therapies, protocol number/drug regimen,
      response, and duration of treatment).

      Each patient who consents to participate in this non-treatment, longitudinal sample protocol
      agrees to allow his or her Medical Record Number (MRN) to be used to track participation on
      DTC clinical trials.

      Objectives:

      Patients will be entered onto this "master" longitudinal protocol to connect research sample
      and treatment data across consecutive DTC clinical trials.

      Biopsy samples collected at time of disease progression on one research trial will be
      evaluated for use as the baseline sample for the next research trial, potentially obviating
      the need for additional biopsies.

      Eligibility:

      Adult patients who are being evaluated for and/or treated for cancer or benign tumors at the
      DTC.

      Design:

      No samples will be collected under this longitudinal protocol, no treatment decisions will be
      made based on data collected, and no new analysis will be performed.

      Specimens for research purposes, as outlined in this protocol, will be those obtained from
      tests and procedures that are done as required by the primary research protocols that a given
      patient is enrolled in. Tissue collected under DTC tissue procurement protocol 06-C-0213 will
      not be used or tracked.

      Sample location and use will be managed in the Repository at the Frederick National
      Laboratory for Cancer Research using LabMatrix software.

      Patients may remain on this longitudinal protocol for the duration of their consent.
observational model: Cohort
time perspective: Retrospective
measure: Obtaining informed consent
time frame: Time of enrollment
description: Collation of research sample and treatment data from individual patients across their participation in consecutive DTC clinical trials
arm group label: 1
description: Patients with cancer or benign tumors being treated on NCI/DTC studies
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alice P Chen, M.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
last name: Jennifer H Zlott
phone: (240) 760-6046
email: zlottjh@mail.nih.gov
last name: Alice P Chen, M.D.
phone: (240) 781-3320
email: chenali@mail.nih.gov
facility: 
status: Recruiting
contact: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-C-0156.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor