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

NCT ID: NCT00898495

Last Updated: 2020-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-11

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

loss of heterozygosity analysis

Intervention Type GENETIC

polymerase chain reaction

Intervention Type GENETIC

polymorphism analysis

Intervention Type GENETIC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

ECOG-ACRIN Cancer Research Group

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Harry H. Yoon, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E1201T1

Identifier Type: -

Identifier Source: secondary_id

ASCO Foundation

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDR0000551712

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Esophageal Cancer Risk Registry
NCT00260585 RECRUITING