Impact of Environmental Exposures on Tumor Risk in Subjects at Risk of Hereditary SDHx Paraganglioma
PGL-EXPO-1
2 other identifiers
observational
100
0 countries
N/A
Brief Summary
The main objective of the pilot phase of PGLEXPO will be to assess the faisability and to precise methodology of a case-control study designed for testing the impact of environmental and professional exposures on the tumoral risk in SDHx-mutation carriers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2022
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2020
CompletedFirst Posted
Study publicly available on registry
July 22, 2020
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedJanuary 19, 2022
January 1, 2022
6 months
July 17, 2020
January 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Feasability of the protocol of a national case/control study (PGL.EXPO2)
Successful pairing of 50 cases with 50 controls
2 years
Secondary Outcomes (2)
Feasibility of matching cases and controls
2 years
Ease of matching cases and controls
2 years
Eligibility Criteria
50 cases and 50 controls will be enrolled in a single referral center where they are regurlarly managed and followed for a SDHx-related tumor risk. They will be matched on their date of birth
You may qualify if:
- Cases: SDHx mutation carriers diagnosed for a SDHx-related tumor
- Controls: SDHx mutation carriers with no SDHx-related tumor
You may not qualify if:
- Incapacity to exercise free and informed consent for the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
- ANSEScollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne-Paule GIMENEZ-ROQUEPLO, MD, PhD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2020
First Posted
July 22, 2020
Study Start
March 1, 2022
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
January 19, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- One year after the last publication
- Access Criteria
- Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization.
Individual participant data (IPD) that underlie results in publication could be shared.