Ignite Creation Date:
2024-05-06 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03124212
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2017-04-10
Brief Title:
Cascade Genetic Testing for Hereditary BreastOvarian Cancer and Lynch Syndrome in Switzerland
Sponsor:
University of Basel
Organization:
University of Basel
Study Overview
Official Title:
Cascade Genetic Testing for Hereditary BreastOvarian Cancer and Lynch Syndrome in Switzerland
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASCADE
Brief Summary:
Breast colorectal ovarian and endometrial cancers constitute approximately 30 of newly diagnosed cancer cases in Switzerland and affect more than 12000 individuals annually Several hundred of these patients are likely to carry known genetic mutations associated with HBOC or LS Genetic testing for hereditary susceptibility to cancer can prevent many cancer deaths through early identification and engagement in high-risk management care that involves intensive surveillance chemoprevention andor prophylactic surgery However current rates of genetic testing indicate that many Swiss mutation carriers and their family members do not use cancer genetic services counseling andor testing either due to lack of coordination of care or due to lack of communication about the mutation among family members
Cascade screening identifies and tests family members of a known mutation carrier It determines whether asymptomatic family members are carriers of the identified mutation and proposes management options to reduce harmful outcomes Robust evidence of basic science and descriptive population-based studies in Switzerland support the necessity of cascade screening for HBOC and LS However translation of this knowledge into public health interventions is lacking
Specific Aims of the CASCADE study are
1 Survey Index Patients diagnosed with HBOC or LS from clinic-based genetic testing records and determine their cancer status and surveillance practices needs for coordination of medical care psychosocial needs patient-provider and patient-family communication needs quality of life willingness to serve as advocates for cancer genetic services for blood relatives
2 Survey first- and second-degree relatives and first cousins identified from pedigrees andor family history records of HBOC and LS Index Patients and determine their cancer and mutation status cancer surveillance practices needs for coordination of medical care barriers and facilitators to using cancer genetic services psychosocial needs patient-provider and patient-family communication needs quality of life willingness to participate in a study designed to increase use of cancer genetic services
3 Explore the influence of patient-provider communication about genetic cancer risk on patient-family communication and the acceptability of a family-based communication coping and decision support intervention with focus groups of mutation carriers and blood relatives
Cascade screening identifies and tests family members of a known mutation carrier It determines whether asymptomatic family members are carriers of the identified mutation and proposes management options to reduce harmful outcomes Robust evidence of basic science and descriptive population-based studies in Switzerland support the necessity of cascade screening for HBOC and LS However translation of this knowledge into public health interventions is lacking
Specific Aims of the CASCADE study are
1 Survey Index Patients diagnosed with HBOC or LS from clinic-based genetic testing records and determine their cancer status and surveillance practices needs for coordination of medical care psychosocial needs patient-provider and patient-family communication needs quality of life willingness to serve as advocates for cancer genetic services for blood relatives
2 Survey first- and second-degree relatives and first cousins identified from pedigrees andor family history records of HBOC and LS Index Patients and determine their cancer and mutation status cancer surveillance practices needs for coordination of medical care barriers and facilitators to using cancer genetic services psychosocial needs patient-provider and patient-family communication needs quality of life willingness to participate in a study designed to increase use of cancer genetic services
3 Explore the influence of patient-provider communication about genetic cancer risk on patient-family communication and the acceptability of a family-based communication coping and decision support intervention with focus groups of mutation carriers and blood relatives
Detailed Description:
Please see study protocol provided in the references
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None