- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07317713
A Two-decade Mortality Risk Analysis of Gastrointestinal Carcinoid Neoplasms: an Updated SEER-based Study 2000-2022
December 19, 2025 updated by: asmaa salama ibrahim, Suez Canal University
Carcinoid tumors are rare neuroendocrine tumors with slowly progressive course with the sites are small intestine accounting for 45%, rectum (20%), appendix (17%), colon (11%), and stomach (7%).
This study focus on the mortality risk analysis for GI carcinoids due to data insufficiency in the literature.
Study Overview
Status
Completed
Conditions
Detailed Description
Carcinoid tumors are rare neuroendocrine tumors with slowly progressive course with the sites are small intestine accounting for 45%, rectum (20%), appendix (17%), colon (11%), and stomach (7%).
This study focus on the mortality risk analysis for GI carcinoids due to data insufficiency in the literature.
This is a retrospective cohort study based on the Surveillance, Epidemiology, and End Results (SEER) database using SEER*Stat software covering approximately 28% of the U.S. The inclusion criteria involved all patients with primary malignant GI carcinoid tumor diagnosed between 2000 and 2021 with sequence number 0 or 1.
Sequence 0 indicated the patient had only one cancer record while sequence 1 indicated the patient may had developed many cancer records following the first one.
In addition, the tumors were restricted to malignant behavior codes (ICD-O-3 Code 3).
We used SEER*Stat software (version 9.0.42.0) to conduct data extraction and statistical analysis.
We used the MP-SIR session to calculate the SMR as Observed/Expected (O/E) with a 95% confidence interval (CI) and the excess risk (ER) was per 10,000.
Statistical significance was achieved at 0.05.
With further analysis, we compared cancer as a cause of death (COD) to other non-cancer COD across different time intervals and primary sites among GI carcinoid tumour.
Study Type
Observational
Enrollment (Actual)
93481
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The inclusion criteria involved all patients with primary malignant GI carcinoid tumor diagnosed between 2000 and 2022 with sequence number 0 or 1.
Sequence 0 indicated the patient had only one cancer record while sequence 1 indicated the patient may had developed many cancer records following the first one.
In addition, the tumors were restricted to malignant behavior codes (ICD-O-3 Code 3).
Description
Inclusion Criteria:
- patients diagnosed with gastrointestinal carcinoid tumor
- from 2000-2022
- histologically confirmed
Exclusion Criteria:
- death certificate only and autopsy only patients
- patients with unknown age data.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The standardized mortality ratio of GI carcinoid tumors
Time Frame: 2000-2022
|
SEER*Stat software (version 9.0.42.0) was used to conduct data extraction and statistical analysis.
The MP-SIR session was used to calculate the SMR as Observed/Expected (O/E) with a 95% confidence interval (CI) and the excess risk was per 10,000.
Statistical significance was achieved at 0.05.
With further analysis, we compared cancer as a cause of death to other non-cancer causes of death across different time intervals and primary sites among GI carcinoid tumour.
|
2000-2022
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 1, 2000
Primary Completion (Actual)
December 30, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
December 19, 2025
First Submitted That Met QC Criteria
December 19, 2025
First Posted (Actual)
January 5, 2026
Study Record Updates
Last Update Posted (Actual)
January 5, 2026
Last Update Submitted That Met QC Criteria
December 19, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A277
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
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