- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001254
Evaluating Pancreatic Tumors in Patients With Zollinger-Ellison Syndrome
April 18, 2024 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Evaluation of the Gastrinoma in Patients With Zollinger-Ellison Syndrome
This protocol concerns the approach to the localization, diagnosis of MEN1 and management of the tumor and the tissue samples in patients with Zollinger-Ellison syndrome.
It details the diagnostic imaging tests to be used to localize the tumor, investigations for MEN1 the subsequent management of the tumor and tissue samples for research.
Study Overview
Status
Completed
Conditions
Detailed Description
This protocol concerns the approach to the localization and management of the tumor in patients with Zollinger-Ellison syndrome.
It details the diagnostic imaging tests to be used to localize the tumor and the subsequent management of the tumor.
Study Type
Observational
Enrollment (Actual)
273
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patient population enrolled in protocol 89-DK-0015
Description
- INCLUSION CRITERIA:
New patients will be evaluated initially as described in the protocol entitled, "Diagnostic evaluation of patients with suspected abnormalities of gastric secretion" (89-DK-0005).
Only those patients that are being treated under the protocol entitled, "Medical Therapy of Zollinger-Ellison Syndrome" (protocol # 89-DK-0015) will be entered into this tumor localization and management protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Patients
Patients will Zollinger-Ellison Syndrome
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine an approach to the localization and management of tumor in patients with ZES.
Time Frame: Yearly
|
localization of tumor
|
Yearly
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robert T Jensen, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wolfe MM, Jensen RT. Zollinger-Ellison syndrome. Current concepts in diagnosis and management. N Engl J Med. 1987 Nov 5;317(19):1200-9. doi: 10.1056/NEJM198711053171907.
- Andersen DK. Current diagnosis and management of Zollinger-Ellison syndrome. Ann Surg. 1989 Dec;210(6):685-703. doi: 10.1097/00000658-198912000-00001.
- Creutzfeldt W, Arnold R, Creutzfeldt C, Track NS. Pathomorphologic, biochemical, and diagnostic aspects of gastrinomas (Zollinger-Ellison syndrome). Hum Pathol. 1975 Jan;6(1):47-76. doi: 10.1016/s0046-8177(75)80109-2.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 29, 1991
Study Registration Dates
First Submitted
November 3, 1999
First Submitted That Met QC Criteria
November 3, 1999
First Posted (Estimated)
November 4, 1999
Study Record Updates
Last Update Posted (Actual)
April 19, 2024
Last Update Submitted That Met QC Criteria
April 18, 2024
Last Verified
September 5, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Disease
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Intestinal Diseases
- Peptic Ulcer
- Duodenal Diseases
- Pancreatic Diseases
- Paraneoplastic Syndromes
- Pancreatic Neoplasms
- Carcinoma, Islet Cell
- Paraneoplastic Endocrine Syndromes
- Syndrome
- Gastrinoma
- Zollinger-Ellison Syndrome
Other Study ID Numbers
- 900137
- 90-DK-0137
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Zollinger Ellison Syndrome
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National Institute of Diabetes and Digestive and...CompletedGastrinoma | Zollinger Ellison SyndromeUnited States
-
National Institute of Diabetes and Digestive and...Completed
-
National Institute of Diabetes and Digestive and...CompletedZollinger Ellison Syndrome | Islet Cell AdenomaUnited States
-
National Institute of Diabetes and Digestive and...CompletedGastrinoma | Zollinger Ellison Syndrome | AchlorhydriaUnited States
-
National Institute of Diabetes and Digestive and...CompletedNeoplasm Metastasis | Zollinger Ellison Syndrome | Islet Cell AdenomaUnited States
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AstraZenecaCompletedGastric Ulcer, Duodenal Ulcer, Anastomotic Ulcer, Reflux Oesophagitis,"Non-erosive Reflux Disease, Zollinger-Ellison SyndromeJapan
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AstraZenecaCompletedZollinger-Ellison SyndromeUnited States, France
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Trio Medicines Ltd.National Institutes of Health (NIH)TerminatedZollinger-Ellison Syndrome
-
Charles Mel Wilcox, MDTakeda Pharmaceuticals North America, Inc.CompletedZollinger-Ellison Syndrome | Multiple Endocrine Neoplasia
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AstraZenecaCompletedZollinger-Ellison Syndrome | Reflux Esophagitis (RE) | Gastric Ulcer (GU) | Duodenal Ulcer (DU) | Anastomotic Ulcer (AU) | Non-erosive Reflux Esophagitis Disease (NERD)Japan