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Genes in Predicting Outcome in Patients With Esophageal Cancer Treated With Cisplatin, Radiation Therapy, and Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00898495
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : July 31, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Brief Summary:

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

Detailed Description:

OBJECTIVES:

  • 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.

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Study Type : Observational
Actual Enrollment : 118 participants
Observational Model: Other
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Comparison of pretreatment clinical tumor staging vs post-treatment pathologic staging (at resection) [ Time Frame: 1 month ]

Biospecimen Retention:   Samples With DNA
Residuals from analysis


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples submitted for research from patients participating in E1201
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of adenocarcinoma of the esophagus

    • Stage I-IV disease
  • Received cisplatin-based treatment on clinical trial ECOG-1201

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898495


Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Harry H. Yoon, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Additional Information:
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Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT00898495    
Other Study ID Numbers: CDR0000551712
E1201T1
ASCO Foundation ( Other Grant/Funding Number: ASCO )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
adenocarcinoma of the esophagus
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer
stage I esophageal cancer
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases