Collection of Blood Samples in Patients With Non-small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT03492801 |
Recruitment Status :
Recruiting
First Posted : April 10, 2018
Last Update Posted : November 18, 2021
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Condition or disease | Intervention/treatment |
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Stage III Non-Small Cell Lung Cancer AJCC v7 Stage IIIA Non-Small Cell Lung Cancer AJCC v7 Stage IIIB Non-Small Cell Lung Cancer AJCC v7 Stage IV Non-Small Cell Lung Cancer AJCC v7 | Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis |
PRIMARY OBJECTIVES:
I. 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.
II. 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 Type : | Observational |
Estimated 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 : | December 11, 2017 |
Estimated Primary Completion Date : | December 11, 2022 |
Estimated Study Completion Date : | December 11, 2023 |

Group/Cohort | Intervention/treatment |
---|---|
Ancillary-Correlative (biospecimen collection)
Patients undergo collection of blood samples at baseline and every 12 weeks for up to 6 times.
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Procedure: Biospecimen Collection
Undergo collection of blood samples Other: Laboratory Biomarker Analysis Correlative studies |
- Blood sample collection for tumor specific mutations study from patients with non-small cell lung cancer [ Time Frame: 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.

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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 |
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

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): NCT03492801
Contact: Aaron Mejia | 323-409-4355 | Aaron.mejia@med.usc.edu |
United States, California | |
USC / Norris Comprehensive Cancer Center | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Aaron Mejia 323-409-4355 Pamela.ward@med.usc.edu | |
Principal Investigator: Pamela Ward, MD |
Principal Investigator: | Pamela Ward, MD | University of Southern California |
Responsible Party: | University of Southern California |
ClinicalTrials.gov Identifier: | NCT03492801 |
Other Study ID Numbers: |
2L-17-1 NCI-2017-02277 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2L-17-1 ( Other Identifier: USC / Norris Comprehensive Cancer Center ) P30CA014089 ( U.S. NIH Grant/Contract ) |
First Posted: | April 10, 2018 Key Record Dates |
Last Update Posted: | November 18, 2021 |
Last Verified: | November 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 |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |