Biological Factors in Predicting Response to Treatment in Patients With Esophageal Cancer or Rectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Analyze various biological factors that can be used as markers to predict response to treatment and correlate with the signaling pathway of EGFR. Secondary 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.

Official Title
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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

Conditions
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Colorectal Cancer, Esophageal Cancer

Intervention / Treatment
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* Genetic: gene expression analysis
* Genetic: mutation analysis
* Genetic: polymorphism analysis
* Other: laboratory biomarker analysis
* Procedure: biopsy
* Procedure: endoscopic biopsy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or rectum Planning to receive neoadjuvant treatment, including radiotherapy or chemoradiotherapy PATIENT CHARACTERISTICS: Not pregnant or nursing No blood disorder Not deprived of freedom or protected by law PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene expression analysis|nan|
|Genetic: mutation analysis|nan|
|Genetic: polymorphism analysis|nan|
|Other: laboratory biomarker analysis|nan|
|Procedure: biopsy|nan|
|Procedure: endoscopic biopsy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Role of predictive factors in the EGFR signaling pathway in response to treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishment of a tissue bank |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, adenocarcinoma of the rectum, recurrent rectal cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent esophageal cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer