Assessing circulating tumor cells in lung cancer patients
Circulating Tumor Cells (CTC) in Lung Cancer
This study is testing how blood samples from lung cancer patients can help tailor new treatments that target DNA repair issues in their cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Indianapolis, Indiana and 2 other locations) |
| Trial ID | NCT02630615 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish circulating tumor cell (CTC) derived xenografts and evaluate the effectiveness of novel DNA repair inhibitors based on DNA repair mutations found in CTC samples. It consists of two cohorts: Cohort A involves a one-time blood draw from patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), while Cohort B includes multiple blood samples collected at various stages of treatment. The study seeks to personalize DNA repair therapy for lung cancer patients by analyzing their CTCs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage 4 NSCLC or extensive-stage SCLC who have not received prior systemic therapy for advanced disease.
Not a fit: Patients with earlier-stage lung cancer or those who have received prior systemic therapy for advanced disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for lung cancer patients based on their unique tumor characteristics.
How similar studies have performed: While the approach of using circulating tumor cells is gaining traction, this specific methodology of personalizing DNA repair therapy based on CTC analysis is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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 Inclusion of Women and Minorities Both men and women of all races and ethnic groups are eligible for this study.
Where this trial is running
Indianapolis, Indiana and 2 other locations
- Indiana University Health Hospital — Indianapolis, Indiana, United States (Recruiting)
- Indiana University Health Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States (Recruiting)
- Roudebush VA Medical Center — Indianapolis, Indiana, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Shadia Jalal, MBBS — Indiana University School of Medicine, Indiana University Simon Cancer Center
- Study coordinator: Emily Scott
- Email: es50@iu.edu
- Phone: (317) 278-0095
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.