Collection of Blood Samples in Patients With Non-small Cell Lung Cancer

Sponsor
University of Southern California (Other)
Overall Status
Recruiting
CT.gov ID
NCT03492801
Collaborator
National Cancer Institute (NCI) (NIH)
40
1
72
0.6

Study Details

Study Description

Brief Summary

This pilot research trial studies the collection of blood samples in monitoring tumor specific mutations in patients with non-small cell lung cancer that has spread to other places in the body or cannot be removed by surgery. Collecting blood samples may help measure the changes in lung cancer, better learn methods to track cancer in the bloodstream, and improve cancer treatments.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biospecimen Collection
  • Other: Laboratory Biomarker Analysis

Detailed Description

PRIMARY OBJECTIVES:
  1. To evaluate the ability of next generation sequencing (NGS) to monitor the evolution of cancer-specific mutations in patients undergoing treatment for non-small cell lung carcinoma and for whom the molecular profile of the tumor cells prior to treatment is known.

  2. Compare the sensitivity of digital droplet polymerase chain reaction (ddPCR) to that of NGS for detecting the appearance of EGFR T790M mutations in patients treated with an EGFR tyrosine kinase inhibitor.

OUTLINE:

Patients undergo collection of blood samples at baseline and every 12 weeks for up to 6 times.

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Longitudinal Monitoring of Tumor Specific Mutations in Patients With Lung Cancer
Actual Study Start Date :
Dec 11, 2017
Anticipated Primary Completion Date :
Dec 11, 2022
Anticipated Study Completion Date :
Dec 11, 2023

Arms and Interventions

Arm Intervention/Treatment
Ancillary-Correlative (biospecimen collection)

Patients undergo collection of blood samples at baseline and every 12 weeks for up to 6 times.

Procedure: Biospecimen Collection
Undergo collection of blood samples

Other: Laboratory Biomarker Analysis
Correlative studies

Outcome Measures

Primary Outcome Measures

  1. Blood sample collection for tumor specific mutations study from patients with non-small cell lung cancer [Baseline to 3 years]

    Blood samples collected will be used to evaluate the ability of next generation sequencing (NGS) to monitor the evolution of cancer-specific mutations in patients undergoing treatment for non-small cell lung carcinoma and for whom the molecular profile of the tumor cells prior to treatment is known.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • A diagnosis of non-small cell lung carcinoma for which the molecular profile of the primary tumor has been obtained from a block of paraffin-embedded, formalin-fixed tissue that remains available

  • Zubrod performance status 0 or 1

  • Patients must have metastatic or unresectable disease and be starting a new line of systemic treatment at the time of enrollment; there are no constraints regarding the time interval between the initial collection of samples for molecular profiling studies at the time of diagnosis prior to treatment and subsequent collections of circulating cell-free deoxyribonucleic acid (DNA) or circulating tumor cells

  • Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1

  • Ability to understand and the willingness to sign a written informed consent; Note: There will be no discrimination between type of treatment or whether they are on continuous versus intermittent therapy

Exclusion Criteria:
  • Known severe anemia (hemoglobin [Hb] < 8g/dL)

  • Patients will be excluded if trackable driver mutations are not identified in the primary tumor tissue

Contacts and Locations

Locations

Site City State Country Postal Code
1 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033

Sponsors and Collaborators

  • University of Southern California
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Pamela Ward, MD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Southern California
ClinicalTrials.gov Identifier:
NCT03492801
Other Study ID Numbers:
  • 2L-17-1
  • NCI-2017-02277
  • 2L-17-1
  • P30CA014089
First Posted:
Apr 10, 2018
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021