Studying Tumor Tissue Samples From Patients With Early-Stage Non-Small Cell Lung Cancer
Validation of Molecular Prognostic Tests in NSCLC
2 other identifiers
observational
1,060
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 20, 2012
CompletedFirst Posted
Study publicly available on registry
January 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2019
CompletedAugust 17, 2021
August 1, 2021
7.2 years
January 20, 2012
August 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence
up to 36 months
Secondary Outcomes (4)
Cancer specific survival
Up to 36 months
Disease-free survival
up to 36 months
Overall survival
up to 36 months
Probability of death due to other causes
up to 36 months
Study Arms (1)
Ancillary-correlative (whole-genome expression)
RNA extracted from archived tumor tissue samples are analyzed for whole-genome expression profiling by Gene Profiling Array cGMP U133 P2 and RT-PCR.
Interventions
Correlative studies
Eligibility Criteria
Patients diagnosed with NSCLC enrolled on the Cancer and Leukemia Group B (CALGB) 140202
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
Bueno R, Richards WG, Harpole DH, Ballman KV, Tsao MS, Chen Z, Wang X, Chen G, Chirieac LR, Chui MH, Franklin WA, Giordano TJ, Govindan R, Joshi MB, Merrick DT, Rivard CJ, Sporn T, van Bokhoven A, Yu H, Shepherd FA, Watson MA, Beer DG, Hirsch FR. Multi-Institutional Prospective Validation of Prognostic mRNA Signatures in Early Stage Squamous Lung Cancer (Alliance). J Thorac Oncol. 2020 Nov;15(11):1748-1757. doi: 10.1016/j.jtho.2020.07.005. Epub 2020 Jul 24.
PMID: 32717408DERIVED
Biospecimen
Tissue samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Raphael Bueno, MD
Brigham and Women's Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2012
First Posted
January 25, 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