- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03622333
Clinic, Pathologic and Genetic Characterization of Patients With Familial Carcinoid Tumors (Study From the GTE, Groupe d'étude Des Tumeurs Endocrines)
Small intestine carcinoid tumors are rare. Small intestine Familial Carcinoid Tumors (FCT) are defined by the occurrence of at least 2 cases of this tumor type in first- or second-degree relatives. The estimated prevalence of FCT is 2.6%-3.7% in patients with small intestine carcinoid tumors. Because of its rarity, epidemiologic, clinic and pathologic features of FCT have been scarcely described. Molecular abnormalities associated with FCT have been poorly explored. Constitutional genetic factors predisposing to FCT have not been discovered to date. Only one abnormality (mutation of the IPMK gene) has been reported in one FCT family only, but not found in other series.
The main objective of this study is to identify the constitutional factors predisposing to small-intestine FCT (and other midgut localizations: ascending colon and appendix). The secondary objectives are to describe the clinic and pathologic features associated with FCT.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Guillaume CADIOT
- Phone Number: 03 26 78 84 41
- Email: gcadiot@chu-reims.fr
Study Contact Backup
- Name: Louis DE MESTIER
- Email: louis.demestier@aphp.fr
Study Locations
-
-
-
Reims, France
- Recruiting
- Damien JOLLY
-
Contact:
- Guillaume CADIOT
- Phone Number: 03 26 78 84 41
- Email: gcadiot@chu-reims.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
inclusion criteria :
- Small-intestine (or ascending colon or appendix) neuroendocrine tumor (proven histologically)
- At least one first- or second-degree relative with a small-intestine (or ascending colon or appendix) neuroendocrine tumor (proven histologically)
- Agreement to participate to the study exclusion criteria :
- Subjects unable to provide consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Familial Carcinoid Tumors
All patients with proven Familial Carcinoid Tumors
|
Tumor DNA extraction Blood sample and constitutional DNA extraction CGH-array, Exome sequencing Bio-informatic analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Deletion
Time Frame: day 0
|
Quantitative Constitutional genetic alterations detected by comparative genomic hybridization (CGH array)
|
day 0
|
duplication
Time Frame: Day 0
|
Quantitative Constitutional genetic alterations detected by comparative genomic hybridization (CGH array)
|
Day 0
|
amplification
Time Frame: Day 0
|
Quantitative Constitutional genetic alterations detected by comparative genomic hybridization (CGH array)
|
Day 0
|
mutation
Time Frame: Day 0
|
qualitative Constitutional genetic alterations detected by NGS (Next Generation Sequencing)
|
Day 0
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PO18020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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