Clinical trial NCT03979612: Evaluation of the Adhesion to the GENEPY Network
Official title: Evaluation of the Adhesion to the Network of Care of People at Genetic Risk of Cancer in Midi-Pyrénées (GENEPY)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hereditary Cancer Syndrome
Hereditary Breast and Ovarian Cancer
Hereditary Colorectal Endometrial Cancer Syndrome
Keywords: breast
hereditary
cancer
ovarian
predisposition
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Adhesion to the GENEPY network
timeFrame: 6 months
measure: Age of relatives
timeFrame: 1 day
measure: Sex of relatives
timeFrame: 1 day
measure: Place of residence of the relatives
timeFrame: 1 day
measure: Proximity to the index case
timeFrame: 1 day
measure: Cancer status Communication
timeFrame: 1 day
Secondary outcomes:
measure: People satisfaction
timeFrame: 1 year
measure: Practionners satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Claudius Regaud - IUCT-Oncopole
state: Occitanie
Study officials:
References:
citation: 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.
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. doi: 10.1007/s10689-004-7991-2.