Evaluation of the Adhesion to the GENEPY Network (GENEPY)

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

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).

Study Overview

• Status: Unknown
• Conditions: Hereditary Breast and Ovarian Cancer; Hereditary Cancer Syndrome; Hereditary Colorectal Endometrial Cancer Syndrome
• Intervention / Treatment: Genetic: inclusion of subjects in the GENEPY network

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.

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

Study Locations

• France
  • Occitanie
    • Toulouse, Occitanie, France, 31059
      • Institut Claudius Regaud - IUCT-Oncopole

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Age of relatives	Age of the relative of the patient who answered the questionnaire	1 day
Sex of relatives	sex of the relative of the patient who answered the questionnaire	1 day
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
Proximity to the index case	relationship of the relatives with the index case according to the latter contact	1 day
Cancer status Communication	Patient's agreement to communicate about his illness to his relative	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
People satisfaction	satisfaction of people who have joined the network (scale of values by questionnaire)	1 year
Practionners satisfaction	satisfaction of general practitioners (scale of values by questionnaire)	1 year

Collaborators and Investigators

• Sponsor: Institut Claudius Regaud

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• General information from National Institue for Cancer (INCa)

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): October 31, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: cancer; breast; ovarian; hereditary; predisposition
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endocrine System Diseases; Disease; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Breast Diseases; Genetic Diseases, Inborn; Ovarian Neoplasms; Breast Neoplasms; Syndrome; Endometrial Neoplasms; Hereditary Breast and Ovarian Cancer Syndrome; Neoplastic Syndromes, Hereditary
• Other Study ID Numbers: 18HLGENE03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Individual Participant Data Set
   Information comments: General information on our web site about investigations from patients data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No