Evaluation of the Adhesion to the GENEPY Network

NCT ID: NCT03979612

Last Updated: 2019-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-12-31

Brief Summary

In order to best meet the needs of all those affected by the genetic risk of cancer in our region, it is important to identify the factors likely to influence the course leading to the GENEPY surveillance network. The aim of this study is to evaluatie the adhesion to the network of care of people at genetic risk of cancer in Midi-Pyrénées (GENEPY).

Detailed Description

This network has been open since November 2015 for people who are genetically predisposed to breast / ovarian cancer. The extension to digestive pathologies (HNPCC syndrome, PAF) is in progress. It concerns not only the persons carrying a mutation also those belonging to a family without identified mutation but whose risk of predisposition is important.

The GENEPY network is based on a collaboration between oncogenetic consultations in the region and professionals practicing in institutions (private, public) and liberal: general practitioners, gynecologists, radiologists, oncologists, gastroenterologists, psychologists ...

It is therefore a multicentric and multidisciplinary network, which aims to promote the local care of people genetically predisposed (or considered at high risk of genetic predisposition), while ensuring a high level of competence, to guarantee an optimal and equitable care on the whole of Midi Pyrenees.

The diagnosis of a new genetic disease in an individual is likely to have implications for other family members who may themselves be at risk of developing the disease and / or passing it on to their children.

The inclusion of subjects in the GENEPY network follows the genealogical study of a case (index) : relatives are identified as potentially at risk. In accordance with the recommendations, but also generally at the wish of the patients, the index case is then asked to inform its relatives and to propose them to go to an oncogenetic consultation of their choice. If these people reside in the Midi Pyrenees Toulouse oncogenetic consultation is open to them. If following this consultation a mutation is identified or that their genetic risk is considered important, they are proposed to join the GENEPY network for their monitoring.

Conditions

Hereditary Cancer Syndrome; Hereditary Breast and Ovarian Cancer; Hereditary Colorectal Endometrial Cancer Syndrome

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Interventions

inclusion of subjects in the GENEPY network

The inclusion of subjects in the GENEPY network follows the genealogical study of a case (index): relatives are identified as potentially at risk. In accordance with the recommendations, but also generally at the wish of the patients (Claes 2003), the index case is then asked to inform its relatives and to propose them to go to an oncogenetic consultation of their choice. If these people reside in the Midi Pyrenees Toulouse oncogenetic consultation is open to them. If following this consultation a mutation is identified or that their genetic risk is considered important, they are proposed to join the GENEPY network for their monitoring.

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

• people with an identified mutation, predisposing to tumors of the breast / ovary or colon / rectum
• people resident in the Midi-Pyrénées region

Exclusion Criteria

• people under 18

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Claudius Regaud - IUCT-Oncopole

Toulouse, Occitanie, France

Countries

France

Central Contacts

Edith Chipoulet, Msc

Role: CONTACT

chipoulet.edith@iuct-oncopole.fr

0531156009

Anne-Laure Fize, MSc

Role: CONTACT

fize.annelaure@iuct-oncopole.fr

0531155059

Facility Contacts

Edith Chipoulet, Msc

Role: primary

chipoulet.edith@iuct-oncopole.fr

0531156009

Anne-Laure Fize, Msc

Role: backup

fize.annelaure@iuct-oncopole.fr

0531155059

References

Eisinger F, Bressac B, Castaigne D, Cottu PH, Lansac J, Lefranc JP, Lesur A, Nogues C, Pierret J, Puy-Pernias S, Sobol H, Tardivon A, Tristant H, Villet R. [Identification and management of hereditary breast-ovarian cancers (2004 update)]. Pathol Biol (Paris). 2006 May;54(4):230-50. doi: 10.1016/j.patbio.2006.02.002. Epub 2006 May 2. French.

Reference Type: RESULT

PMID: 16632260 (View on PubMed)

Landsbergen K, Verhaak C, Kraaimaat F, Hoogerbrugge N. Genetic uptake in BRCA-mutation families is related to emotional and behavioral communication characteristics of index patients. Fam Cancer. 2005;4(2):115-9. doi: 10.1007/s10689-004-7991-2.

Reference Type: RESULT

PMID: 15951961 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

General information on our web site about investigations from patients data

View Document

Related Links

http://www.e-cancer.fr/Professionnels-de-sante/Recommandations-et-outils-d-aide-a-la-pratique/Oncogenetique-ou-Cancers-avec-predispositions-genetiques

General information from National Institue for Cancer (INCa)

Other Identifiers

18HLGENE03

Identifier Type: -

Identifier Source: org_study_id