Facilitated cascade testing (FaCT): a randomized controlled trial.
BRCA1 protein
BRCA2 protein
ovarian cancer
Journal
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society
ISSN: 1525-1438
Titre abrégé: Int J Gynecol Cancer
Pays: England
ID NLM: 9111626
Informations de publication
Date de publication:
05 2021
05 2021
Historique:
accepted:
24
11
2020
pubmed:
15
1
2021
medline:
16
2
2022
entrez:
14
1
2021
Statut:
ppublish
Résumé
Identifying mutation-carrying relatives of patients with hereditary cancer syndromes via cascade testing is an underused first step in primary cancer prevention. A feasibility study of facilitated genetic testing of at-risk relatives of patients with a known pathogenic mutation demonstrated encouraging uptake of cascade testing. Our primary objective is to compare the proportion of genetic testing of identified first-degree relatives of probands with a confirmed We hypothesize that facilitated cascade testing will drive significantly higher uptake of genetic testing than the standard of care. The FaCT (Facilitated Cascade Testing) trial is a prospective multi-institutional randomized study comparing the efficacy of a multicomponent facilitated cascade testing intervention with the standard of care. Patients with a known Adult participants who are first-degree relatives of a patient with a Analyses will assess the proportion of first-degree relatives identified by the proband who complete genetic testing by 6 months in the intervention arm versus the control arm. One hundred and fifty probands with a BRCA1/2 mutation will be randomized. Each proband is expected to provide an average of 3 relatives, for an expected 450 participants. January 2024. NCT04613440.
Sections du résumé
BACKGROUND
Identifying mutation-carrying relatives of patients with hereditary cancer syndromes via cascade testing is an underused first step in primary cancer prevention. A feasibility study of facilitated genetic testing of at-risk relatives of patients with a known pathogenic mutation demonstrated encouraging uptake of cascade testing.
PRIMARY OBJECTIVE
Our primary objective is to compare the proportion of genetic testing of identified first-degree relatives of probands with a confirmed
STUDY HYPOTHESIS
We hypothesize that facilitated cascade testing will drive significantly higher uptake of genetic testing than the standard of care.
TRIAL DESIGN
The FaCT (Facilitated Cascade Testing) trial is a prospective multi-institutional randomized study comparing the efficacy of a multicomponent facilitated cascade testing intervention with the standard of care. Patients with a known
MAJOR INCLUSION/EXCLUSION CRITERIA
Adult participants who are first-degree relatives of a patient with a
PRIMARY ENDPOINT
Analyses will assess the proportion of first-degree relatives identified by the proband who complete genetic testing by 6 months in the intervention arm versus the control arm.
SAMPLE SIZE
One hundred and fifty probands with a BRCA1/2 mutation will be randomized. Each proband is expected to provide an average of 3 relatives, for an expected 450 participants.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS
January 2024.
TRIAL REGISTRATION
NCT04613440.
Identifiants
pubmed: 33443030
pii: ijgc-2020-002118
doi: 10.1136/ijgc-2020-002118
pmc: PMC8603783
mid: NIHMS1708825
doi:
Substances chimiques
BRCA1 Protein
0
BRCA2 Protein
0
Banques de données
ClinicalTrials.gov
['NCT04613440']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
779-783Subventions
Organisme : NCI NIH HHS
ID : T32 CA101642
Pays : United States
Organisme : NCI NIH HHS
ID : P30 CA016672
Pays : United States
Organisme : NCATS NIH HHS
ID : KL2 TR001874
Pays : United States
Organisme : NCI NIH HHS
ID : P30 CA008748
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002384
Pays : United States
Organisme : NCATS NIH HHS
ID : KL2 TR002385
Pays : United States
Organisme : NCI NIH HHS
ID : K08 CA234333
Pays : United States
Informations de copyright
© IGCS and ESGO 2021. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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