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

NCT01503619 | Completed

• 3 other identifiers: CALGB-151111CDR0000721552NCI-2012-00104
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Identification of genetic alterations in human SCLC (driver or passenger mutations)

  Baseline

Secondary Outcomes (1)

• Gene expression between samples with or without mutations

  Baseline

Study Arms (1)

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.

Other: laboratory biomarker analysis

Interventions

laboratory biomarker analysis OTHER

Correlative studies

Basic science (biomarker analysis)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with small cell lung cancer enrolled on the Cancer and Leukemia Group B (CALGB) 140202 study

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, blood

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• David MacPherson, PhD

  Fred Hutchinson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 4, 2012
• Study Start: January 1, 2012
• Primary Completion: February 27, 2019
• Study Completion: February 27, 2019
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

US (1)