Circulating Tumor Cells (CTC) in Lung Cancer
J
Jessica MacLean
Primary Investigator
S
Shadia Jalal, MD
Primary Investigator
Enrolling By Invitation
100 years and younger
All
Phase
N/A
4 Locations
Brief description of study
What is the purpose of the study?
The purpose of this study is to examine rare cells called circulating tumor cells that are present in a person's blood when they have lung cancer to see if there is a relationship between a person's cancer symptoms and the number and characteristics of those cells at various times before and during cancer treatment.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
- 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 of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Lung Neoplasms, Lung Cancer
-
Age: - 100 Years
-
Gender: All
Updated on
01 Aug 2024.
Study ID: IUSCC-0567, 1512076915, TX5713
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