<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/NCT02250404</url>
  </required_header>
  <id_info>
    <org_study_id>2O-13-1</org_study_id>
    <secondary_id>NCI-2014-01910</secondary_id>
    <secondary_id>HS-14-00382</secondary_id>
    <secondary_id>2O-13-1</secondary_id>
    <secondary_id>UL1TR000130</secondary_id>
    <secondary_id>P30CA014089</secondary_id>
    <nct_id>NCT02250404</nct_id>
  </id_info>
  <brief_title>Molecular Signatures of Relapse in Tissue Samples From Patients With Small Cell Lung Cancer Who Are Receiving Cisplatin and Etoposide</brief_title>
  <official_title>Pilot Study of the Identification of the Molecular Signatures of Relapse in Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</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 pilot research trial studies molecular signatures of the return of cancer after a period&#xD;
      of improvement (relapse) in tissue samples from patients with small cell lung cancer who are&#xD;
      receiving or planning to receive cisplatin and etoposide. Studying samples of tissue from&#xD;
      patients with small cell lung cancer in the laboratory may help doctors learn more about the&#xD;
      changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer&#xD;
      relapse.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To collect and analyze small cell lung cancer (SCLC) tumor DNA and ribonucleic acid (RNA)&#xD;
      from 3 human patients before and after relapse to identify the molecular signatures of&#xD;
      relapse.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Previously collected tissue samples are analyzed via RNA sequencing and DNA methylation at&#xD;
      baseline. Patients also undergo collection of tissue samples for analysis at relapse.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI left institution&#xD;
  </why_stopped>
  <start_date type="Actual">August 22, 2014</start_date>
  <completion_date type="Anticipated">August 22, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 22, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in tumor tissue molecular profiles</measure>
    <time_frame>Baseline to up to 1 year</time_frame>
    <description>Profiles of pre- and post-relapse tumor tissue will be compared. Data will be compared with mouse data and overlaps determined.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Ancillary-Correlative (molecular profile)</arm_group_label>
    <description>Previously collected tissue samples are analyzed via RNA sequencing and DNA methylation at baseline. Patients also undergo collection of tissue samples for analysis at relapse.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cytology specimen collection procedure</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Ancillary-Correlative (molecular profile)</arm_group_label>
    <other_name>cytologic sampling</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Ancillary-Correlative (molecular profile)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects seen at USC Norris Comprehensive Cancer Center and at LAC USC Medical Center with&#xD;
        histologically confirmed small cell lung cancer will be recruited for this trial.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient seen at Norris or County with histologically confirmed SCLC, with tissue&#xD;
             in the Norris Cancer Center Tumor Repository&#xD;
&#xD;
          -  Patients must be undergoing or about to start first line treatment with cisplatin and&#xD;
             etoposide&#xD;
&#xD;
          -  Patients may not have a second malignancy&#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>Barbara Gitlitz</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Los Angeles County-USC Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>May 23, 2018</last_update_submitted>
  <last_update_submitted_qc>May 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
  </condition_browse>
  <!-- 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/NCT02250404
org study id: 2O-13-1
secondary id: NCI-2014-01910
secondary id: HS-14-00382
secondary id: 2O-13-1
secondary id: UL1TR000130
secondary id: P30CA014089
nct id: NCT02250404
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot research trial studies molecular signatures of the return of cancer after a period
      of improvement (relapse) in tissue samples from patients with small cell lung cancer who are
      receiving or planning to receive cisplatin and etoposide. Studying samples of tissue from
      patients with small cell lung cancer in the laboratory may help doctors learn more about the
      changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer
      relapse.
PRIMARY OBJECTIVES:

      I. To collect and analyze small cell lung cancer (SCLC) tumor DNA and ribonucleic acid (RNA)
      from 3 human patients before and after relapse to identify the molecular signatures of
      relapse.

      OUTLINE:

      Previously collected tissue samples are analyzed via RNA sequencing and DNA methylation at
      baseline. Patients also undergo collection of tissue samples for analysis at relapse.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Change in tumor tissue molecular profiles
time frame: Baseline to up to 1 year
description: Profiles of pre- and post-relapse tumor tissue will be compared. Data will be compared with mouse data and overlaps determined.
arm group label: Ancillary-Correlative (molecular profile)
description: Previously collected tissue samples are analyzed via RNA sequencing and DNA methylation at baseline. Patients also undergo collection of tissue samples for analysis at relapse.
intervention type: Other
intervention name: cytology specimen collection procedure
description: Correlative studies
arm group label: Ancillary-Correlative (molecular profile)
other name: cytologic sampling
intervention type: Other
intervention name: laboratory biomarker analysis
description: Correlative studies
arm group label: Ancillary-Correlative (molecular profile)
Tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Barbara Gitlitz
role: Principal Investigator
affiliation: University of Southern California
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma