免费获得国外相关药品，最快 1 个工作日回馈药物信息
Evaluation of the Adhesion to the GENEPY Network (GENEPY)
| Condition or disease | Intervention/treatment |
|---|---|
| Hereditary Cancer Syndrome Hereditary Breast and Ovarian Cancer Hereditary Colorectal Endometrial Cancer Syndrome | Genetic: inclusion of subjects in the GENEPY network |
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 [Patient Registry] |
| Estimated Enrollment : | 450 participants |
| Observational Model: | Ecologic or Community |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 1 Day |
| Official Title: | Evaluation of the Adhesion to the Network of Care of People at Genetic Risk of Cancer in Midi-Pyrénées (GENEPY) |
| Estimated Study Start Date : | August 1, 2019 |
| Estimated Primary Completion Date : | October 31, 2019 |
| Estimated Study Completion Date : | December 31, 2020 |
- Adhesion to the GENEPY network [ Time Frame: 6 months ]Network membership rate : comparison between the number of relatives who received the invitation and the number of them who joined the network.
- Age of relatives [ Time Frame: 1 day ]Age of the relative of the patient who answered the questionnaire
- Sex of relatives [ Time Frame: 1 day ]sex of the relative of the patient who answered the questionnaire
- Place of residence of the relatives [ Time Frame: 1 day ]distance from the offer of care and level of deprivation (for the relative of the patient who answered the questionnaire)
- Proximity to the index case [ Time Frame: 1 day ]relationship of the relatives with the index case according to the latter contact
- Cancer status Communication [ Time Frame: 1 day ]Patient's agreement to communicate about his illness to his relative
- People satisfaction [ Time Frame: 1 year ]satisfaction of people who have joined the network (scale of values by questionnaire)
- Practionners satisfaction [ Time Frame: 1 year ]satisfaction of general practitioners (scale of values by questionnaire)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 4, 2019 | ||||
| First Posted Date | June 7, 2019 | ||||
| Last Update Posted Date | June 7, 2019 | ||||
| Estimated Study Start Date | August 1, 2019 | ||||
| Estimated Primary Completion Date | October 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | 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) | ||||
| 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. |
||||
| Study Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Ecologic or Community Time Perspective: Prospective |
||||
| Target Follow-Up Duration | 1 Day | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition |
|
||||
| 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.
|
||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
450 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 31, 2020 | ||||
| Estimated Primary Completion Date | October 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03979612 | ||||
| Other Study ID Numbers | 18HLGENE03 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement |
|
||||
| Responsible Party | Institut Claudius Regaud | ||||
| Study Sponsor | Institut Claudius Regaud | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Institut Claudius Regaud | ||||
| Verification Date | June 2019 | ||||
