Clinical and Molecular Description of PKD1 and PKD2 Mutation Negative Carriers in ADPKD

NCT ID: NCT02112136

Last Updated: 2021-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-12

Study Completion Date

2020-12-12

Brief Summary

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The aim of this study is to identify families with ADPKD , characterize the phenotype and screen for mutations in known genes (PKD1 and PKD2, and then HNF1b and UMOD in PKD1 PKD2 negative carriers).

Genome wide analysis will be performed in families without mutations identified.

Detailed Description

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* Inclusion of ADPKD patients in 20 different centers of Nephrology in the Western part of France
* Characterization of the Phenotype
* Collect DNA sample
* Analysis of PKD1 and PKD2 genes first
* Analysis of HNFIb and UMOD for PKD1 and PKD2 negative patients
* Recruitment of affected and non-affected relatives of PKD1 and PKD2 negative ADPKD patients
* Identify new genes involved in ADPKD using exome sequencing in PKD1 and PKD2 negative pedigrees

Conditions

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Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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GeneQuest

* No drug will be administrated in this study
* Blood collection

Group Type OTHER

Blood Collection

Intervention Type OTHER

Phenotype and Genotype Analysis, Biological Analysis

Interventions

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Blood Collection

Phenotype and Genotype Analysis, Biological Analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with a diagnosis of ADPKD
* Written Informed Consent
* Affiliated or benefiting from a national insurance


* Relatives with a diagnosis of ADPKD (ADPKD relatives)
* And Relatives over age 30 for whom the diagnosis of ADPKD has been discarded (non ADPKD relatives) with renal ultrasonography performed after age 30.
* Written Informed consent
* Affiliated or benefiting from a national insurance

Exclusion Criteria

* Subjects unable to provide written informed consent
* Previous Molecular analysis of PKD1 and PKD2 genes with identification of the pathogenic mutation


* Subjects unable to provide written informed consent
* Age under 30 for the "non-affected" relatives
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emilie Cornec-Le Gall, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU de Brest

Locations

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CHU Angers

Angers, , France

Site Status

AUB Brest

Brest, , France

Site Status

Centre de néphrologie et de dialyse d'Armorique

Brest, , France

Site Status

CHRU Brest

Brest, , France

Site Status

CH Laval

Laval, , France

Site Status

CH du Mans

Le Mans, , France

Site Status

ECHO dialyse

Le Mans, , France

Site Status

Centre de dialyse de Lorient

Lorient, , France

Site Status

CH Bretagne Sud

Lorient, , France

Site Status

Hôpital Hôtel Dieu - CHU Nantes

Nantes, , France

Site Status

CH Niort

Niort, , France

Site Status

ECHO les Sables d'Olonne

Olonne-sur-Mer, , France

Site Status

Hôpital Jean Bernard - CHU Poitiers

Poitiers, , France

Site Status

CHCB site de Noyal Pontivy

Pontivy, , France

Site Status

CH Laënnec

Quimper, , France

Site Status

AUB Santé

Quimper, , France

Site Status

Hôpital Pontchaillou

Rennes, , France

Site Status

Echo Csmn

Rezé, , France

Site Status

Centre de Pérharidy

Roscoff, , France

Site Status

Hôpital Yves Le Foll

Saint-Brieuc, , France

Site Status

ECHO Centre Ambulatoire

Saint-Herblain, , France

Site Status

CH de Saint Nazaire

Saint-Nazaire, , France

Site Status

CH Saint Malo

St-Malo, , France

Site Status

Hôpital Bretonneau - CHU Tours

Tours, , France

Site Status

CH Bretagne Atlantique - Site de Vannes

Vannes, , France

Site Status

Countries

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France

References

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Lefevre S, Audrezet MP, Halimi JM, Longuet H, Bridoux F, Ecotiere L, Augusto JF, Duveau A, Renaudineau E, Vigneau C, Frouget T, Charasse C, Gueguen L, Perrichot R, Couvrat G, Seret G, Le Meur Y, Cornec-Le Gall E; Genkyst Study Group. Diagnosis and risk factors for intracranial aneurysms in autosomal polycystic kidney disease: a cross-sectional study from the Genkyst cohort. Nephrol Dial Transplant. 2022 Oct 19;37(11):2223-2233. doi: 10.1093/ndt/gfac027.

Reference Type DERIVED
PMID: 35108395 (View on PubMed)

Other Identifiers

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RB14.017 GeneQuest

Identifier Type: -

Identifier Source: org_study_id

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