Genes in Predicting Outcome in Patients With Esophageal Cancer Treated With Cisplatin, Radiation Therapy, and Surgery
|ClinicalTrials.gov Identifier: NCT00898495|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 19, 2017
RATIONALE: Studying samples of tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict a patient's response to treatment.
PURPOSE: This laboratory study is looking at genes to see if they can predict outcome in patients with esophageal cancer treated with cisplatin, radiation therapy, and surgery.
|Condition or disease||Intervention/treatment|
|Esophageal Cancer||Genetic: loss of heterozygosity analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis|
- Correlate patient outcomes with neoplastic cell genotypes, specifically 18 single nucleotide polymorphisms (SNPs) in 16 major genes involved in platinum metabolism and disposition and DNA repair, in patients with esophageal cancer treated with neoadjuvant cisplatin-based chemoradiotherapy followed by surgical resection on clinical trial ECOG-1201.
- Correlate patient outcomes with neoplastic cell genotypes, specifically loss of heterozygosity, in these patients.
- Correlate patient outcomes with normal (germline) cell genotypes, specifically SNPs related to platinum metabolism and disposition and DNA repair.
- Compare the predictive ability of neoplastic vs germline cell genotypes.
OUTLINE: This is a retrospective, cohort, multicenter study.
Neoplastic and normal (germline) cells are collected from pretreatment and post-treatment specimens using laser-capture microdissection. Single nucleotide polymorphisms are examined by real-time PCR. Loss of heterozygosity is assessed by analyzing short tandem repeat markers in neoplastic and germline tissue.
|Study Type :||Observational|
|Actual Enrollment :||118 participants|
|Official Title:||Single Nucleotide Polymorphisms (SNP) in Platinum-/Radiation Pathway Genes to Predict Outcome in Patients With Esophageal Adenocarcinoma Treated With Cisplatin-Based Chemoradiotherapy Followed by Surgical Resection|
|Actual Study Start Date :||May 11, 2007|
|Actual Primary Completion Date :||December 31, 2008|
|Actual Study Completion Date :||December 31, 2008|
- Comparison of pretreatment clinical tumor staging vs post-treatment pathologic staging (at resection) [ Time Frame: 1 month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898495
|Study Chair:||Harry H. Yoon, MD||Sidney Kimmel Comprehensive Cancer Center|