NCT00898495

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

1.6 years

First QC Date

May 9, 2009

Last Update Submit

July 29, 2020

Conditions

Esophageal Cancer

Keywords

adenocarcinoma of the esophagusstage II esophageal cancerstage III esophageal cancerstage IV esophageal cancerstage I esophageal cancer

Outcome Measures

Primary Outcomes (1)

  • Comparison of pretreatment clinical tumor staging vs post-treatment pathologic staging (at resection)

    1 month

Interventions

loss of heterozygosity analysisGENETIC
polymerase chain reactionGENETIC
polymorphism analysisGENETIC

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Samples submitted for research from patients participating in E1201

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Residuals from analysis

MeSH Terms

Conditions

Esophageal NeoplasmsAdenocarcinoma Of Esophagus

Interventions

Polymerase Chain ReactionAmplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification TechniquesGenetic TechniquesInvestigative TechniquesDNA Fingerprinting

Study Officials

  • Harry H. Yoon, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

May 11, 2007

Primary Completion

December 31, 2008

Study Completion

December 31, 2008

Last Updated

July 31, 2020

Record last verified: 2020-07