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Circulating Tumor Cells (CTC) in Lung Cancer

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ClinicalTrials.gov Identifier: NCT02630615
Recruitment Status : Recruiting
First Posted : December 15, 2015
Last Update Posted : April 7, 2022
Sponsor:
Information provided by (Responsible Party):
Shadia Jalal, Indiana University School of Medicine

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).

Condition or disease Intervention/treatment
Lung Neoplasms Other: Blood draw

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 in the outpatient clinic. Patients can participate in both cohorts simultaneously, or only one cohort per patient preference.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Circulating Tumor Cells (CTC) in Lung Cancer
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
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
Whole blood will be collected using standard phlebotomy procedures

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
Whole blood will be collected using standard phlebotomy procedures




Primary Outcome Measures :
  1. Assess activity of novel DNA repair inhibitors as a function of DNA repair mutations detected in CTC samples [ Time Frame: Baseline ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630615


Contacts
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Contact: Maggie Uhrich, RN 317-278-8860 muhrich@iu.edu

Locations
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United States, Indiana
Indiana University Health Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Maggie Uhrich, RN    317-278-8860    muhrich@iu.edu   
Principal Investigator: Shadia Jalal, MBBS         
Indiana University Health Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Maggie Uhrich, RN    317-278-8860    muhrich@iu.edu   
Principal Investigator: Shadia Jalal, MBBS         
Sponsors and Collaborators
Shadia Jalal
Investigators
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Principal Investigator: Shadia Jalal, MBBS Indiana University School of Medicine, Indiana University Simon Cancer Center
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Responsible Party: Shadia Jalal, Assistant Research Professor, Assistant Professor of Clinical Medicine, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT02630615    
Other Study ID Numbers: IUSCC-0567
1512076915 ( Other Identifier: Indiana University IRB )
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: April 7, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shadia Jalal, Indiana University School of Medicine:
Circulating tumor cells
Additional relevant MeSH terms:
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Neoplastic Cells, Circulating
Lung Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases