Hereditary Cancer SyndromeGENEPYNCT03979612
Evaluation of the Adhesion to the GENEPY Network
An observational study of Hereditary Cancer Syndrome and Hereditary Breast and Ovarian Cancer, run by Institut Claudius Regaud at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hereditary Cancer Syndrome, Hereditary Breast and Ovarian Cancer, Hereditary Colorectal Endometrial Cancer Syndrome
- What is being tested?
- inclusion of subjects in the GENEPY network
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2019to 31 Dec 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- people with an identified mutation, predisposing to tumors of the breast / ovary or colon / rectum
- people resident in the Midi-Pyrénées region
Who cannot join
- people under 18
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Claudius Regaud - IUCT-Oncopole
Toulouse, Occitanie, 31059
Edith Chipoulet, Msc, 0531156009, chipoulet.edith@iuct-oncopole.fr
Anne-Laure Fize, Msc, 0531155059, fize.annelaure@iuct-oncopole.fr
About this study
Official title: 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).
Read the 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
- Being tested
- inclusion of subjects in the GENEPY network
- Keywords
- breast, hereditary, cancer, ovarian, predisposition
- Medical subject headings
- Neoplastic Syndromes, Hereditary, Hereditary Breast and Ovarian Cancer Syndrome, Colorectal Neoplasms, Hereditary Nonpolyposis, Neoplasms, Disease Susceptibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inclusion of subjects in the GENEPY networkGenetic
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Age of relatives
Age of the relative of the patient who answered the questionnaire
Measured: 1 day
Sex of relatives
sex of the relative of the patient who answered the questionnaire
Measured: 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)
Measured: 1 day
Proximity to the index case
relationship of the relatives with the index case according to the latter contact
Measured: 1 day
Cancer status Communication
Patient's agreement to communicate about his illness to his relative
Measured: 1 day
Secondary outcomes (2)
People satisfaction
satisfaction of people who have joined the network (scale of values by questionnaire)
Measured: 1 year
Practionners satisfaction
satisfaction of general practitioners (scale of values by questionnaire)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Aug 2019 (estimated)
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hereditary Cancer SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979612
- Sponsor's protocol ID
- 18HLGENE03
- Acronym
- GENEPY
- Status last verified
- Jun 2019
- First submitted
- 4 Jun 2019
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16632260Landsbergen 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.
PubMed 15951961
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Adhesion to the Network of Care of People at Genetic Risk of Cancer in Midi-Pyrénées (GENEPY)
- ClinicalTrials.gov ID
- NCT03979612
- Acronym / sponsor ID
- GENEPY / 18HLGENE03
- Conditions
- Hereditary Cancer Syndrome, Hereditary Breast and Ovarian Cancer, Hereditary Colorectal Endometrial Cancer Syndrome
- Keywords
- breast, hereditary, cancer, ovarian, predisposition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- people with an identified mutation, predisposing to tumors of the breast / ovary or colon / rectum
- people resident in the Midi-Pyrénées region
Key exclusion criteria (1 listed)
- people under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inclusion of subjects in the GENEPY networkThe 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. | Genetic | – |
Primary outcome
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
2 secondary outcomes
People satisfaction
Time frame: 1 year
Practionners satisfaction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Results publication: PubMed 16632260Eisinger 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.
- Results publication: PubMed 15951961Landsbergen 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.
- General information from National Institue for Cancer (INCa)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Cancer Syndrome and Hereditary Breast and Ovarian Cancer, run by Institut Claudius Regaud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edith Chipoulet, Msc (0531156009, chipoulet.edith@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adhesion to the GENEPY network (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03979612, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.