Biomarkers in Predicting Response in Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy
Participation in the Lung Adjuvant Cisplatin Evaluation Biological Program (LACE-BIO). A Study of Prognostic and Predictive Markers in Early Stage Non-Small Cell Lung Cancer
4 other identifiers
observational
241
1 country
1
Brief Summary
This research trial studies prognostic and predictive markers in patients with early stage non-small cell lung cancer receiving chemotherapy. Prognostic markers are patient or tumor factors that predict patient survival independent of treatment. Predictive markers are factors that may influence and predict the outcome of treatment in terms of either response or survival benefit. Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about cancer and identify biomarkers related to cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2008
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 10, 2011
CompletedFirst Posted
Study publicly available on registry
February 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2016
CompletedJanuary 20, 2021
January 1, 2021
7.6 years
February 10, 2011
January 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
up to 3 years
Secondary Outcomes (1)
Disease-free survival
Up to 3 years
Study Arms (1)
Ancillary-Correlative (IHC)
Previously collected tissue samples are analyzed by IHC.
Interventions
Eligibility Criteria
Patients registered to Cancer and Leukemia Group B (CALGB) 9633
You may qualify if:
- Registration to CALGB9633 for this study
- Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required
- Informed consent:
- The subject population to be studied in this protocol includes patients selected from CALGB 9633 for whom an available specimen is present at the Alliance Ohio State University (OSU); all such patients have signed a written informed consent document meeting all federal, state, and institutional guidelines as part of entry into that trial
- Only cases with adequate tumor formalin FFPE material without depleting the available clinical block(s) are eligible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Biospecimen
Tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Stephen Graziano, MD
State University of New York - Upstate Medical University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2011
First Posted
February 11, 2011
Study Start
July 1, 2008
Primary Completion
February 2, 2016
Study Completion
February 2, 2016
Last Updated
January 20, 2021
Record last verified: 2021-01