Esophageal Cancer Risk Registry

NCT00260585 | Recruiting DMC

• 2 other identifiers: STUDY19080072NCT00260585
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to identify markers in the blood and tissue that could indicate risk factors for the development and progression of esophagus cancer. This research aims to collect medical history, blood, and tissue samples from patients who present with an esophageal disorder. Identifying genetic and behavioral risk factors involved in the development of esophageal cancer might allow for early detection and prevention. Survival and an opportunity for a cure with esophageal cancer will depend greatly on the stage of diagnosis. Tumors can develop changes in their genetic (hereditary) make-up, and these changes can sometimes be seen in normal tissues before the development of cancer. These genetic (hereditary) changes can serve as tumor markers and can be detected using methods that study changes in genetic material like DNA and RNA. The analysis of proteins can provide additional information. By identifying changes in these molecules that are different or altered in cancer, the investigators can use methods and tests for the detection of these changes.

Conditions

Esophageal Cancer; Gastroesophageal Reflux Disease (GERD); Esophageal Diseases; Hiatal Hernia; Esophageal Achalasia

Keywords

gastroesophageal reflux disease; GERD; hiatal hernia; achalasia; Barrett's metaplasia; Anti-Reflux Surgery; Known/suspected esophageal/gastroesophageal junction tumor; Esophageal disorders such as Barrett's metaplasia; Symptomatic gastroesophageal reflux disease

Interventions

Survey of client health, personal habits, family history PROCEDURE

A questionnaire is administered at the time of consent.

Blood specimen for non-DNA and DNA parts PROCEDURE

Blood specimen is collected prior to surgery or at the time of scheduled routine surgical procedure(s), and at the time of routine follow-up visits

Biopsy of esophageal/stomach tissue, lymph nodes, tumor PROCEDURE

Tissue from the biopsies is collected intraoperatively.

Biopsies, oral (saliva) and/or secretions, washings or mucosal scrapings/brushing from routine clinical surveillance endoscopies PROCEDURE

Tissue from the biopsies, oral (saliva) and/or secretions, washings or mucosal scrapings/brushings are collected intraoperatively.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will be selected from the investigator's clinic.

You may qualify if:

• Known or suspected esophageal or gastroesophageal junction malignancy
• Known Barrett's metaplasia
• Clinical management of symptomatic gastroesophageal reflux disease (GERD)
• Achalasia
• Hiatal hernia

You may not qualify if:

• Elevated pre-operative bloodwork will not have the additional biopsies taken.
• Platelet count less than 150,000, partial thromboplastin time (PTT) of 50 or above, and/or International Normalized Ratio (INR) of 1.8 or above will not have the additional biopsies taken.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Department of Cardiothoracic Surgery

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, tissue, lymph nodes

MeSH Terms

Conditions

Esophageal Neoplasms; Gastroesophageal Reflux; Esophageal Diseases; Hernia, Hiatal; Esophageal Achalasia

Interventions

Blood Specimen Collection; Tumor Burden; Biopsy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Body Weights and Measures; Anthropometry; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical

Study Officials

• James D. Luketich, MD

  Department of Cardiothoracic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie A Ward, BSN

CONTACT

412-647-8583; wardj@upmc.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 28, 2005
• First Posted: December 1, 2005
• Study Start: June 1, 1999
• Primary Completion (Estimated): December 1, 2050
• Study Completion (Estimated): December 1, 2050
• Last Updated: April 14, 2026

Record last verified: 2026-03

Locations

US (1)