Back to resultsHereditary Paraganglioma: Evaluation of Screening Methods to Detect Tumors in SDH Positive Carriers
Primary Purpose
Paraganglioma, Pheochromocytoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
diagnosis methods
Sponsored by
About this trial
This is an interventional diagnostic trial for Paraganglioma
Eligibility Criteria
Inclusion Criteria: identification of an SDH (SDHD, SDHD, SDHC) germline mutation
Sites / Locations
- Européen Georges Pompidou Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00188019
First Posted
September 12, 2005
Last Updated
July 22, 2015
Sponsor
University Hospital, Angers
Collaborators
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00188019
Brief Title
Hereditary Paraganglioma: Evaluation of Screening Methods to Detect Tumors in SDH Positive Carriers
Official Title
Evaluation Des méthodes de dépistage du Paragangliome héréditaire Chez Les Sujets prédisposés génétiquement
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
Collaborators
Assistance Publique - Hôpitaux de Paris
4. Oversight
5. Study Description
Brief Summary
Hereditary paraganglioma -due to SDH (SDHD, SDHB, SDHC) germline mutations- causes paragangliomas and pheochromocytomas. Presymptomatic genetic testing should be offered to all first-degree relatives if an SDH mutation is detected in an index case with paraganglioma or pheochromocytoma. The main objective of our national clinical research project is to test different screening methods to detect presymptomatic tumors in order to establish guidelines for the work-up and the follow-up of SDH mutation carriers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paraganglioma, Pheochromocytoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
248 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
diagnosis methods
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: identification of an SDH (SDHD, SDHD, SDHC) germline mutation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Rohmer, MD
Organizational Affiliation
University Angers Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne-Paule Gimenez-Roqueplo, MD, PhD
Organizational Affiliation
Paris-Descartes University, Européen Georges Pompidou Hospital, Assistance Publique des Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Européen Georges Pompidou Hospital
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Learn more about this trial
Hereditary Paraganglioma: Evaluation of Screening Methods to Detect Tumors in SDH Positive Carriers
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