Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-04-05 @ 10:50 AM
Study NCT ID:
NCT00628368
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2008-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Factors in Predicting Response to Treatment in Patients With Esophageal Cancer or Rectal Cancer
Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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:
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: