Esophageal CancerNCT00260585
Esophageal Cancer Risk Registry
An observational study of Esophageal Cancer and Gastroesophageal Reflux Disease (GERD), run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastroesophageal Reflux Disease (GERD), Esophageal Diseases
- What is being tested?
- Survey of client health, personal habits, family history, Blood specimen for non-DNA and DNA parts and Biopsy of esophageal/stomach tissue, lymph nodes, tumor
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 7,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1999to Dec 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients will be selected from the investigator's clinic.
Who may be able to join
- Known or suspected esophageal or gastroesophageal junction malignancy
- Known Barrett's metaplasia
- Clinical management of symptomatic gastroesophageal reflux disease (GERD)
- Achalasia
- Hiatal hernia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Department of Cardiothoracic Surgery
Pittsburgh, Pennsylvania, 15232
Julie Ward, BSN, 412-647-8583, wardj@upmc.edu
James Luketich, MD
About this study
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.
Read the detailed description
We will enroll patients with esophageal cancer, patients who are at risk for developing esophageal cancer, and patients who have a non-cancerous esophageal disorder. All patients will be asked to fill out a questionnaire about their general health and personal habits, and about their relatives' medical history; this will be done during the preoperative clinic visit. Prior to or at the time of the surgical procedure(s), and at the time of routine follow-up visits, a sample of blood (about 3 tablespoons) will be drawn for research.
For patients undergoing an endoscopy after the normal biopsies are taken, several small samples will be taken from the esophagus, gastroesophageal junction, and stomach. We will also collect oral (saliva) and/or secretions, washings or mucosal scrapings/brushing from the region of the mouth, esophagus, stomach, and small bowel. In some subjects (e.g. Roux-en-y esophagojejunostomy procedure or colon interposition), secretions, washings or scrapings/brushings from the esophagus, remnant stomach, small and large bowel can also be collected. These should total no more than eight samples.
For patients undergoing an anti-reflux procedure with or without a Collis gastroplasty a lymph node is normally removed. We will receive a small piece of that lymph node after the pathologist has done the routine pathological evaluation of that node.
If the collis procedure is done, a new esophagus is formed and a small piece of stomach tissue is discarded. We will study the ordinarily discarded tissue for the transformation of cells from a normal to an abnormal state. The lymph node and stomach tissue will be collected only once for the study.
For patients undergoing an esophagectomy (removal of the esophagus) or a staging procedure (performed to determine size, exact location, and spread of tumor to nearby areas) prior to an esophagectomy small pieces of tissue will be collected (from tumor, adjacent normal esophageal lining, parts of lymph nodes, and any other tissues removed as a part of the normal procedure) from your esophagectomy or staging specimens. The samples collected will be analyzed for genetic changes in the DNA and the RNA. The samples will be stored in a locked laboratory at the Hillman Cancer Center Research Pavilion indefinitely or until the samples are depleted.
You may be contacted in the future to learn the results of any cancer screening tests you had undergone and whether anyone else in your family had developed cancer. This information will be entered in a computer data base for future study.
We may continue to collect additional blood samples and endoscopic biopsies, secretions, and scrapings during your routine clinical surveillance endoscopies. Again biopsies for normal patient management will be obtained first.
- Conditions
- Esophageal Cancer, Gastroesophageal Reflux Disease (GERD), Esophageal Diseases, Hiatal Hernia, Esophageal Achalasia
- Being tested
- 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
- 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
- Medical subject headings
- Esophageal Neoplasms, Gastroesophageal Reflux, Esophageal Diseases, Hernia, Hiatal, Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey of client health, personal habits, family historyProcedure or surgery
A questionnaire is administered at the time of consent.
Blood specimen for non-DNA and DNA partsProcedure or surgery
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, tumorProcedure or surgery
Tissue from the biopsies is collected intraoperatively.
Biopsies, oral (saliva) and/or secretions, washings or mucosal scrapings/brushing from routine clinical surveillance endoscopiesProcedure or surgery
Tissue from the biopsies, oral (saliva) and/or secretions, washings or mucosal scrapings/brushings are collected intraoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startJun 1999
- Primary completionDec 2050 (estimated)
- Study completionDec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, James Luketich, University of Pittsburgh
- Investigators
- James D. Luketich, MD, Principal investigator, Department of Cardiothoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260585
- Sponsor's protocol ID
- STUDY19080072
- Other IDs
- NCT00260585
- Status last verified
- Mar 2026
- First submitted
- 28 Nov 2005
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Cancer Risk Registry
- ClinicalTrials.gov ID
- NCT00260585
- Acronym / sponsor ID
- STUDY19080072
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Jun 1999 (actual)
- Primary completion
- Dec 2050 (estimated)
- Study completion
- Dec 2050 (estimated)
- First posted
- 1 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We will enroll patients with esophageal cancer, patients who are at risk for developing esophageal cancer, and patients who have a non-cancerous esophageal disorder. All patients will be asked to fill out a questionnaire about their general health and personal habits, and about their relatives' medical history; this will be done during the preoperative clinic visit. Prior to or at the time of the surgical procedure(s), and at the time of routine follow-up visits, a sample of blood (about 3 tablespoons) will be drawn for research.
For patients undergoing an endoscopy after the normal biopsies are taken, several small samples will be taken from the esophagus, gastroesophageal junction, and stomach. We will also collect oral (saliva) and/or secretions, washings or mucosal scrapings/brushing from the region of the mouth, esophagus, stomach, and small bowel. In some subjects (e.g. Roux-en-y esophagojejunostomy procedure or colon interposition), secretions, washings or scrapings/brushings from the esophagus, remnant stomach, small and large bowel can also be collected. These should total no more than eight samples.
For patients undergoing an anti-reflux procedure with or without a Collis gastroplasty a lymph node is normally removed. We will receive a small piece of that lymph node after the pathologist has done the routine pathological evaluation of that node.
If the collis procedure is done, a new esophagus is formed and a small piece of stomach tissue is discarded. We will study the ordinarily discarded tissue for the transformation of cells from a normal to an abnormal state. The lymph node and stomach tissue will be collected only once for the study.
For patients undergoing an esophagectomy (removal of the esophagus) or a staging procedure (performed to determine size, exact location, and spread of tumor to nearby areas) prior to an esophagectomy small pieces of tissue will be collected (from tumor, adjacent normal esophageal lining, parts of lymph nodes, and any other tissues removed as a part of the normal procedure) from your esophagectomy or staging specimens. The samples collected will be analyzed for genetic changes in the DNA and the RNA. The samples will be stored in a locked laboratory at the Hillman Cancer Center Research Pavilion indefinitely or until the samples are depleted.
You may be contacted in the future to learn the results of any cancer screening tests you had undergone and whether anyone else in your family had developed cancer. This information will be entered in a computer data base for future study.
We may continue to collect additional blood samples and endoscopic biopsies, secretions, and scrapings during your routine clinical surveillance endoscopies. Again biopsies for normal patient management will be obtained first.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will be selected from the investigator's clinic.
Key inclusion criteria (5 listed)
- Known or suspected esophageal or gastroesophageal junction malignancy
- Known Barrett's metaplasia
- Clinical management of symptomatic gastroesophageal reflux disease (GERD)
- Achalasia
- Hiatal hernia
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey of client health, personal habits, family historyA questionnaire is administered at the time of consent. | Procedure or surgery | – |
| Blood specimen for non-DNA and DNA partsBlood 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 | Procedure or surgery | – |
| Biopsy of esophageal/stomach tissue, lymph nodes, tumorTissue from the biopsies is collected intraoperatively. | Procedure or surgery | – |
| Biopsies, oral (saliva) and/or secretions, washings or mucosal scrapings/brushing from routine clinical surveillance endoscopiesTissue from the biopsies, oral (saliva) and/or secretions, washings or mucosal scrapings/brushings are collected intraoperatively. | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James D. Luketich, MD principal investigator
Department of Cardiothoracic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Gastroesophageal Reflux Disease (GERD), run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie A Ward, BSN (412-647-8583, wardj@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.