Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
80

Summary

Conditions
Lung Neoplasms
Type
Observational
Design
Observational Model: Case-OnlyTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT02630615
Collaborators
Not Provided
Investigators
Principal Investigator: Shadia Jalal, MBBS Indiana University School of Medicine, Indiana University Simon Cancer Center