NCT01035398

Brief Summary

RATIONALE: Gathering information about genes, cigarette smoking, and diet may help doctors learn more about risk factors that may cause esophageal cancer. PURPOSE: This clinical trial is studying genetic and environmental risk factors related to esophageal cancer.

Trial Health

75
On Track

Trial Health Score

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

Timeline
4mo left

Started Apr 2000

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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 Progress99%
Apr 2000Sep 2026

Study Start

First participant enrolled

April 1, 2000

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2009

Completed
16.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

26.2 years

First QC Date

December 17, 2009

Last Update Submit

November 26, 2024

Conditions

Esophageal Cancer

Keywords

stage 0 esophageal cancerstage I esophageal cancerstage II esophageal cancerstage III esophageal cancerstage IV esophageal cancer

Outcome Measures

Primary Outcomes (4)

  • Polymorphisms in various pathways, DNA repair, free-radical formation, inflammatory genes, metastatic potential, and cell cycle or tumor suppression in blood samples

    2000-2016

  • Comparison of presence or absence of variant polymorphisms between cases and controls

    2000-2016

  • Correlation between polymorphisms in blood samples and polymorphisms in tissue specimens

    2000-2016

  • Analyses of dietary factors and Helicobacter pylori infection (previous vs current)

    2000-2016

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Diagnosis of esophageal cancer (patient) * Newly diagnosed disease * Receiving care at Massachusetts General Hospital, Thoracic Oncology Center * Friend or spouse of patient (healthy participants) PATIENT CHARACTERISTICS: * No concurrent psychiatric incapacity or dementia 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

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Harvard School of Public Health

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • David C. Christiani, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pulmonary Associate

Study Record Dates

First Submitted

December 17, 2009

First Posted

December 18, 2009

Study Start

April 1, 2000

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)