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Completed

NCT Number: NCT04481152

Impact of Environmental Exposures on Tumor Risk in Subjects at Risk of Hereditary SDHx Paraganglioma

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

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Key information

Conditions

Genetic Predisposition Disease Attributes Disease Susceptibility Environmental Exposure Genetic Predisposition to Disease Pathologic Processes Pathological Conditions, Signs and Symptoms SDH Gene Mutation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital européen Georges-Pompidou

Paris, 75015, France

About this study

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.

Patients will be selected from subjects with a mutation in one of the SDHx genes. The cases will have developed a tumor, while the controls will be tumor-free. Controls will be matched to the cases according to sex, age and type of gene affected. Past exposures will be sought through a telephone questionnaire.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cases: SDHx mutation carriers diagnosed for a SDHx-related tumor
  • Controls: SDHx mutation carriers with no SDHx-related tumor

Exclusion criteria

Incapacity to exercise free and informed consent for the study

Treatment and study plan

Primary outcomes

  1. Feasability of the protocol of a national case/control study (PGL.EXPO2)

    Time frame: 2 years

    Successful pairing of 50 cases with 50 controls

Secondary outcomes

  1. Feasibility of matching cases and controls

    Time frame: 2 years

    Proportion of cases for which a control could be identified

  2. Ease of matching cases and controls

    Time frame: 2 years

    Mean number of controls matching for a case

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • ANSES
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Impact of Environmental Exposures on Tumor Risk in Subjects at Risk of Hereditary SDHx-related Paragangliomas, Pilot Phase

Acronym: PGL-EXPO-1

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2020
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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