Evaluation of the Adhesion to the GENEPY Network

Hereditary Breast and Ovarian Cancer Clinical Trial

— GENEPY  

Official title:

Evaluation of the Adhesion to the Network of Care of People at Genetic Risk of Cancer in Midi-Pyrénées (GENEPY)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03979612
• Other study ID #: 18HLGENE03
• Status: Not yet recruiting
• Start date: August 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2019
• Source: Institut Claudius Regaud
• Contact: Edith Chipoulet, Msc
• Phone: 0531156009
• Email: chipoulet.edith[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: December 31, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms, Hereditary Nonpolyposis
• Endometrial Neoplasms
• Hereditary Breast and Ovarian Cancer
• Hereditary Breast and Ovarian Cancer Syndrome
• Hereditary Cancer Syndrome
• Hereditary Colorectal Endometrial Cancer Syndrome
• Neoplastic Syndromes, Hereditary
• Syndrome

Intervention

Genetic:
• 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.

Locations

Country	Name	City	State
France	Institut Claudius Regaud - IUCT-Oncopole	Toulouse	Occitanie

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

References & Publications (2)

Eisinger F, Bressac B, Castaigne D, Cottu PH, Lansac J, Lefranc JP, Lesur A, Noguès 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 (Pa — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adhesion to the GENEPY network	Network membership rate : comparison between the number of relatives who received the invitation and the number of them who joined the network.	6 months
Primary	Age of relatives	Age of the relative of the patient who answered the questionnaire	1 day
Primary	Sex of relatives	sex of the relative of the patient who answered the questionnaire	1 day
Primary	Place of residence of the relatives	distance from the offer of care and level of deprivation (for the relative of the patient who answered the questionnaire)	1 day
Primary	Proximity to the index case	relationship of the relatives with the index case according to the latter contact	1 day
Primary	Cancer status Communication	Patient's agreement to communicate about his illness to his relative	1 day
Secondary	People satisfaction	satisfaction of people who have joined the network (scale of values by questionnaire)	1 year
Secondary	Practionners satisfaction	satisfaction of general practitioners (scale of values by questionnaire)	1 year

External Links

•   General information from National Institue for Cancer (INCa)