Clinical Trials /

Circulating Tumor Cells (CTC) in Lung Cancer

NCT02630615

Description:

The primary objective of this study is to establish circulating tumor cell (CTC) derived xenografts and assess the activity of novel DNA repair inhibitors as a function of DNA repair mutations detected in CTC samples (personalize DNA repair therapy).

Related Conditions:
  • Non-Small Cell Lung Carcinoma
  • Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Trial Eligibility

Document

Title

  • Brief Title: Circulating Tumor Cells (CTC) in Lung Cancer
  • Official Title: Circulating Tumor Cells (CTC) in Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: IUSCC-0567
  • SECONDARY ID: 1512076915
  • NCT ID: NCT02630615

Conditions

  • Lung Neoplasms

Purpose

The primary objective of this study is to establish circulating tumor cell (CTC) derived xenografts and assess the activity of novel DNA repair inhibitors as a function of DNA repair mutations detected in CTC samples (personalize DNA repair therapy).

Detailed Description

      There are 3 cohorts for this study. Cohort A & Cohort B are for patient subjects. Patients
      can participate in both cohorts simultaneously, or only one cohort per patient preference.

      The investigators anticipate that most patients who participate in Cohort B will also
      participate in Cohort A because Cohort A only requires a one-time blood draw at baseline.
      Cohort C is for healthy volunteers. The purpose of recruiting health volunteers is purely for
      testing of the CTC chip system as the investigators routinely spike (inject) tumor cell lines
      in healthy human blood to ensure optimal CTC yield (quality control).

      Cohort A: 20 patients with NSCLC and 20 patients with SCLC. Blood samples will be collected
      from eligible patients only once at baseline. These samples will be immediately processed for
      CTCs and CTC derived xenografts.

      Cohort B: 15 patients with NSCLC and 15 patients with SCLC. Blood samples will be collected
      from eligible patients at baseline just prior to initiation of therapy. Samples will also be
      collected on day 1 of every cycle of therapy for 4 cycles (typical cycles are 21 days for
      chemotherapy, 28 days for targeted therapy and 14 days for immune therapy). At the time of
      initiation of the treatment break, blood samples will be collected. During the treatment
      break, patients will be followed every 6-12 weeks with imaging studies, and we will collect
      blood samples at each visit. At the time of disease progression in the event patient goes on
      best supportive care, the last blood draw will be at the time of this decision as there will
      unlikely be any further imaging studies going forward. If a patient is found to have disease
      progression while on active therapy, the next blood draw will be on the first day of the next
      therapy and time point of subsequent blood draws will depend on the type of therapy the
      patient receives. The goal is to define whether CTC loads whether CTC loads predict symptoms,
      response, and disease recurrence.

      For Cohorts A & B: Investigators will make every attempt to time the blood collection to
      coincide with blood collection for therapeutic purposes in order to minimize discomfort.
      Blood sample collection will take place in the outpatient clinic. Patients can participate in
      both cohorts simultaneously, or only one cohort per patient preference.

      Cohort C: 10 subjects. Blood samples will be collected from eligible health volunteers only
      once. These samples will be used to test the CTC chip system as investigators routinely spike
      (inject) tumor cell lines in healthy human blood to ensure optimal CTC yield (quality
      control). Two samples of peripheral blood will be collected and taken to the Principal
      Investigator's lab for processing.
    

Trial Arms

NameTypeDescriptionInterventions
Cohort A (one-time blood sample)Blood samples will be collected from eligible patients only once at baseline. These samples will be immediately processed for CTCs and CTC derived xenografts. For Cohorts A & B: Patients can participate in both cohorts simultaneously, or only one cohort per patient preference.
    Cohort B (multiple blood samples)Blood samples will be collected from eligible patients at baseline just prior to initiation of therapy. Samples will also be collected on day 1 of every cycle of therapy for 4 cycles (typical cycles are 21 days for chemotherapy, 28 days for targeted therapy and 14 days for immune therapy). At the time of initiation of the treatment break, blood samples will be collected. During the treatment break, patients will be followed every 6-12 weeks with imaging studies, and we will collect blood samples at each visit. At the time of disease progression in the event patient goes on best supportive care, the last blood draw will be at the time of this decision as there will unlikely be any further imaging studies going forward. If a patient is found to have disease progression while on active therapy, the next blood draw will be on the first day of the next therapy and time point of subsequent blood draws will depend on the type of therapy the patient receives.
      Cohort C (healthy volunteers)Blood samples will be collected from eligible health volunteers only once. These samples will be used to test the CTC chip system. Two tubes of peripheral blood will be collected and taken to the PI's lab for processing.

        Eligibility Criteria

                Inclusion Criteria Cohort A (one-time blood sample) & Cohort B (multiple blood samples)
        
                  -  Histologically or cytologically confirmed lung cancer (both non-small cell lung cancer
                     and small cell lung cancer are allowed)
        
                  -  Stage 4 NSCLC or extensive-stage SCLC
        
                  -  Newly diagnosed disease with no prior systemic therapy for advanced disease Note:
                     Patients that have received prior adjuvant chemotherapy or prior chemoradiotherapy for
                     earlier stage lung cancer are allowed if treatment was completed ≥3 months.
        
                  -  Age ≥ 18 years
        
                  -  Ability to understand and the willingness to sign a written informed consent document
        
                Cohort C (healthy volunteers)
        
                  -  Age > 18 years but ≤ 95 years at the time of consent
        
                  -  Subjects must be English-speaking
        
                  -  Must voluntarily sign the most current informed consent and HIPAA documents prior to
                     study participation.
        
                  -  Have no prior history of malignancy in the past 2 years with the exception of basal
                     cell and squamous cell carcinoma of the skin. Other cancers with low potential for
                     metastasis, such as in situ cancers can also be enrolled as healthy volunteers.
        
                Inclusion of Women and Minorities Both men and women of all races and ethnic groups are
                eligible for this study.
              
        Maximum Eligible Age:N/A
        Minimum Eligible Age:18 Years
        Eligible Gender:All
        Healthy Volunteers:Accepts Healthy Volunteers

        Primary Outcome Measures

        Measure:Assess activity of novel DNA repair inhibitors as a function of DNA repair mutations detected in CTC samples
        Time Frame:Baseline
        Safety Issue:
        Description:All analyses will be done by disease group (i.e., NSCLC and SCLC). For the primary objective, CTC derived xenografts will be generated, and CTCs will be analyzed for DNA repair defects, and used to evaluate the activity of novel DNA repair inhibitors. We will look at CTCs by group [specific DNA defect (yes or no), treated vs untreated] using histograms and compare groups statistically using two group Satterthwaite t-tests with a 0.050 two-sided significance level.

        Details

        Phase:
        Primary Purpose:Observational
        Overall Status:Recruiting
        Lead Sponsor:Shadia Jalal

        Trial Keywords

        • Circulating tumor cells

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