Studying Tumor Tissue Samples From Patients With Early-Stage Non-Small Cell Lung Cancer

Completed

• Conditions: Lung Cancer
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT01517971
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

This research trial studies biomarkers in predicting the risk of cancer returning after surgery in tissue samples of patients with early-stage non-small cell lung cancer. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer and predict how well patients will respond to treatment.

Detailed Description

PRIMARY OBJECTIVES:

I. To develop and validate a clinically useful molecular prognostic signature based on ribonucleic acid (RNA)-expression arrays to accurately distinguish between good and poor outcome in patients with stage 1B non-small cell lung cancer (NSCLC) (T2aN0M0) by predicting the risk of cancer recurrence after surgery.

SECONDARY OBJECTIVES:

I. To develop and validate a clinically useful prognostic signature for stage 1A NSCLC (T1a-bN0M0) that accurately predicts the risk of post-operative cancer recurrence and is part of a prognostic classifier, which also includes histological, pathological, and demographic parameters as in the primary objective.

II. To determine the effects on test accuracy of the histological subtype (adenocarcinoma \[AC\] vs squamous cell \[SQA\]) for each of the stage specific prognostic classifiers.

III. To determine the relevant statistical features, including accuracy of predicting overall survival, cancer specific survival, and disease free survival at 3 and 5 years, for each of the prognostic classifiers validated.

IV. To utilize the validated prognostic signatures and classifiers in stage 1B NSCLC to determine whether these can reliably predict good outcome among stage II NSCLC patients.

OUTLINE:

RNA extracted from archived tumor tissue samples are analyzed for whole-genome expression by Affymetrix microarrays (Gene Profiling Array cGMP U133 P2) and reverse transcriptase-polymerase chain reaction (RT-PCR).

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-20
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-25
• Primary Completion: 2019-02-27
• Study Completion: 2019-02-27
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1060

Inclusion Criteria

• Registration to CALGB-140202
• The subject population to be studied in this protocol includes patients selected from CALGB-140202; all such patients have signed a written informed consent document meeting all federal, state and institutional guidelines as part of entry into that trial; the CALGB does not require that a separate consent form be signed for this study
• All samples to be studied were obtained and stored as part of CALGB-140202; the material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information; in no instance will the patient be contacted directly
• Tumor specimens need to have 40% tumor content to be included

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-correlative (whole-genome expression)	laboratory biomarker analysis	RNA extracted from archived tumor tissue samples are analyzed for whole-genome expression profiling by Gene Profiling Array cGMP U133 P2 and RT-PCR.

Primary Outcome Measures

Name	Time	Method
Recurrence	up to 36 months

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	up to 36 months
Overall survival	up to 36 months
Cancer specific survival	Up to 36 months
Probability of death due to other causes	up to 36 months

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States