Studying Biomarkers in Tumor Tissue and Blood Samples From Patients With Small Cell Lung Cancer Registered on CALGB-140202

NCT ID: NCT01503619

Last Updated: 2021-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2019-02-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tumor tissue and blood samples from patients with small cell lung cancer registered on CALGB-140202.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OBJECTIVES:

Primary

* To identify the major genetic alterations in human small cell lung cancer (SCLC) using next-generation sequencing and focusing on mutations in coding sequence.

Secondary

* To follow up with in-depth assessment of candidate oncogenes and tumor suppressor genes using gene expression analysis, cell culture systems, and murine models of SCLC.

OUTLINE: DNA isolated from archived tumor tissue and blood samples are analyzed for genetic mutations and gene expression profiling using Illumina exome sequencing. Results are compared with transcriptome of tumors (or cell lines) with and without the specific mutation. Cell culture studies overexpressing or inhibiting the genes of interest are also performed in a mouse model to identified potential drivers of small cell lung cancer.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Basic science (biomarker analysis)

DNA isolated from archived tumor tissue and blood samples are analyzed for genetic mutations and gene expression profiling using Illumina exome sequencing. Results are compared with transcriptome of tumors (or cell lines) with and without the specific mutation. Cell culture studies overexpressing or inhibiting the genes of interest are also performed in a mouse model to identified potential drivers of small cell lung cancer.

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients must have been registered to CALGB-140202 trial in which tumor material (frozen tissue and paired blood specimens) is available
* Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David MacPherson, PhD

Role: STUDY_CHAIR

Fred Hutchinson Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CDR0000721552

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-00104

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-151111

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.