Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT00260585

Conditions

Esophageal Cancer

Gastroesophageal Reflux Disease (GERD)

Esophageal Diseases

Hiatal Hernia

Esophageal Achalasia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Survey of client health, personal habits, family history

Blood specimen for non-DNA and DNA parts

Biopsy of esophageal/stomach tissue, lymph nodes, tumor

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

Study Details

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

Study ID

NCT00260585

Start date

Jun, 1999

Status verified date

Mar, 2026

Completion date

Dec, 2050

Anticipated

Primary completion date

Dec, 2050

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

7000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Survey of client health, personal habits, family history

A questionnaire is administered at the time of consent.

Blood specimen for non-DNA and DNA parts

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

Tissue from the biopsies is collected intraoperatively.

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

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

Central Contacts and Locations

Central contacts

Julie A Ward, BSN

412-647-8583wardj@upmc.edu

Locations

Department of Cardiothoracic Surgery

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Julie Ward, BSN

412-647-8583wardj@upmc.edu

Principal Investigator:

James Luketich, MD

More Information

Sponsor

University of Pittsburgh

Last update posted

Apr 14, 2026

Last verified

Mar, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-04-14.