Clinical trial NCT02630615: Circulating Tumor Cells (CTC) in Lung Cancer
Official title: Circulating Tumor Cells (CTC) in Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Neoplasms
Keywords: Circulating tumor cells
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

Detailed description: There are 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.

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 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 either in the outpatient clinic, or while inpatient (at IUSCCC, Indiana University Hospital, or Eskenazi hospital). Patients can participate in both cohorts simultaneously, or only one cohort per patient preference.

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

Inclusion of Women and Minorities Both men and women of all races and ethnic groups are eligible for this study.

Primary outcomes:
measure: Assess activity of novel DNA repair inhibitors as a function of DNA repair mutations detected in CTC samples
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Melvin and Bren Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Roudebush VA Medical Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine, Indiana University Simon Cancer Center
name: Shadia Jalal, MBBS
role: PRINCIPAL_INVESTIGATOR
References: