Biological Factors in Predicting Response to Treatment in Patients With Esophageal Cancer or Rectal Cancer
Recruitment status was: Recruiting
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. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This clinical trial is studying how well biological factors work in predicting response to treatment in patients with esophageal cancer or rectal cancer.
Genetic: gene expression analysis
Genetic: mutation analysis
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Procedure: endoscopic biopsy
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Diagnostic
|Official Title:||Study to Analyze the Predictive Role of Factors Implicated in the Signaling Pathway of the EGFR in Response to Treatment With Neoadjuvant Chemoradiotherapy in Patients With Cancer of the Esophagus or Rectum|
- Role of predictive factors in the EGFR signaling pathway in response to treatment
- Establishment of a tissue bank
|Study Start Date:||November 2005|
|Estimated Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
- Analyze various biological factors that can be used as markers to predict response to treatment and correlate with the signaling pathway of EGFR.
- Establish a tissue bank to store information about the response to treatment and survival.
OUTLINE: Patients undergo endoscopy, 11 biopsies of tumor tissue, and 3 biopsies of healthy mucosa. Blood samples are also collected. Samples are analyzed for the expression of 4 receptors in the EGFR family, polymorphisms at intron 1 of the EGFR gene, and gene mutations in downstream signaling pathways.
After surgery, patients are followed every 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628368
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Study Chair:||Marc Ychou, MD, PhD||Institut du Cancer de Montpellier - Val d'Aurelle|