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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00898495
Other study ID # CDR0000551712
Secondary ID E1201T1ASCO Foun
Status Completed
Phase
First received
Last updated
Start date May 11, 2007
Est. completion date December 31, 2008

Study information

Verified date July 2020
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date December 31, 2008
Est. primary completion date December 31, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
loss of heterozygosity analysis

polymerase chain reaction

polymorphism analysis


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of pretreatment clinical tumor staging vs post-treatment pathologic staging (at resection) 1 month
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