The Risk of Second Primary Gastrointestinal Malignancies... | NCT07291752

Studies
The Risk of Second Primary Gastrointestinal Malignancies Following Primary Gastrointestinal Carcinoid Tumors: a SEER Based Study 2000-2022

NCT07291752

Sponsor

Suez Canal University

Status

Completed

Last Update Posted

Dec 18, 2025Actual

Enrollment

93,481Actual

Phase

Not provided

Conditions

Carcinoid Tumor
Second Primary Malignant Neoplasm

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2000Actual

Primary Completion Date

Dec 30, 2022Actual

Completion Date

Dec 30, 2022Actual

First Submitted Date

Dec 5, 2025

First Submission Date that Met QC Criteria

Dec 5, 2025

First Posted Date

Dec 18, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2025

Last Update Posted Date

Dec 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Carcinoid tumors are rare neuroendocrine tumors with slowly progressive course. Carcinoid tumors are the most common gastrointestinal (GI) neuroendocrine tumors. The most common sites of GI carcinoids are small intestine accounting for 45%, rectum (20%), appendix (17%), colon (11%), and stomach (7%). Some studies reported an association between neuroendocrine tumors and multiple malignancies. However, the presence of neuroendocrine tumors combined with multiple primary GI tumors is considered an exotic event in the literature with only few case studies and case series. So the aim of this study is to assess the risk of GI malignancies following primary GI carcinoids.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

93,481Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The standardized incidence ratio and excess risk of second primary gastrointestinal malignancies following primary gastrointestinal carcinoid tumors	The surveillance, epidemiology and End Results (SEER) database was used to calculate the standardized incidence ratio (SIR) as Observed/Expected (O/E) and calculated the excess risk for second primary gastrointestinal malignancies following primary gastrointestinal carcinoid tumors	Jan, 2000 till Dec, 2022
The standardized incidence ratio and excess risk of gastrointestinal second primary malignancies stratified according to the primary gastrointestinal carcinoids site.		from Jan, 2000 till Dec, 2022

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients diagnosed with gastrointestinal carcinoid tumor.
patients diagnosed from 2000 till 2022

Exclusion Criteria:

patients diagnosed with autopsy only or death certificate only.
patients lacking age documentation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients diagnosed with gastrointestinal carcinoid tumor

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002276	Carcinoid Tumor
D016609	Neoplasms, Second Primary
D009369	Neoplasms

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

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Browse Branches

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