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Trial record 3 of 27 for:    Recruiting, Not yet recruiting, Available Studies | "Carcinoid Tumor"

Clinic, Pathologic and Genetic Characterization of Patients With Familial Carcinoid Tumors (Study From the GTE, Groupe d'étude Des Tumeurs Endocrines)

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ClinicalTrials.gov Identifier: NCT03622333
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Small Intestinal Carcinoid Tumors Genetic: Research of constitutional genetic alterations Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Clinic, Pathologic and Genetic Characterization of Patients With Familial Carcinoid Tumors (Study From the GTE, Groupe d'étude Des Tumeurs Endocrines)
Actual Study Start Date : May 28, 2018
Estimated Primary Completion Date : May 28, 2022
Estimated Study Completion Date : November 28, 2022


Arm Intervention/treatment
Experimental: Familial Carcinoid Tumors
All patients with proven Familial Carcinoid Tumors
Genetic: Research of constitutional genetic alterations
Tumor DNA extraction Blood sample and constitutional DNA extraction CGH-array, Exome sequencing Bio-informatic analysis




Primary Outcome Measures :
  1. Deletion [ Time Frame: day 0 ]
    Quantitative Constitutional genetic alterations detected by comparative genomic hybridization (CGH array)

  2. duplication [ Time Frame: Day 0 ]
    Quantitative Constitutional genetic alterations detected by comparative genomic hybridization (CGH array)

  3. amplification [ Time Frame: Day 0 ]
    Quantitative Constitutional genetic alterations detected by comparative genomic hybridization (CGH array)

  4. mutation [ Time Frame: Day 0 ]
    qualitative Constitutional genetic alterations detected by NGS (Next Generation Sequencing)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622333


Contacts
Contact: Guillaume CADIOT 03 26 78 84 41 gcadiot@chu-reims.fr
Contact: Louis DE MESTIER louis.demestier@aphp.fr

Locations
France
Damien JOLLY Recruiting
Reims, France
Contact: Guillaume CADIOT    03 26 78 84 41    gcadiot@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03622333     History of Changes
Other Study ID Numbers: PO18020
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CHU de Reims:
Neuroendocrine tumors
carcinoid tumors
midgut
small intestine
genetic predisposition
hereditary

Additional relevant MeSH terms:
Carcinoid Tumor
Intestinal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases