Circulating Tumor Cells (CTC) in Lung Cancer

NCT02630615 | Active Not Recruiting DMC

• 2 other identifiers: IUSCC-05671512076915
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Lung Neoplasms

Keywords

Circulating tumor cells

Outcome Measures

Primary Outcomes (1)

• Assess activity of novel DNA repair inhibitors as a function of DNA repair mutations detected in CTC samples

  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.

  Baseline

Study Arms (2)

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.

Other: Blood draw

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.

Other: Blood draw

Interventions

Blood draw OTHER

Whole blood will be collected using standard phlebotomy procedures

Cohort A (one-time blood sample); Cohort B (multiple blood samples)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will enroll 2 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. We 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Shadia Jalal: lead

Study Sites (2)

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Roudebush VA Medical Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplastic Cells, Circulating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Shadia Jalal, MBBS

  Indiana University School of Medicine, Indiana University Simon Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Research Professor, Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 15, 2015
• Study Start: October 19, 2017
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)