Viewing Study NCT04903782



Ignite Creation Date: 2024-05-06 @ 4:12 PM
Last Modification Date: 2024-10-26 @ 2:05 PM
Study NCT ID: NCT04903782
Status: RECRUITING
Last Update Posted: 2022-11-04
First Post: 2021-03-16

Brief Title: Cancer Predisposition Testing by Family-based Whole-genome Sequencing WGS in Every Child With Newly Diagnosed Cancer
Sponsor: Sydney Childrens Hospitals Network
Organization: Sydney Childrens Hospitals Network

Study Overview

Official Title: Assessment of the Utility of Family-based Trio Whole-genome Sequencing for Cancer Predisposition Testing in Sequential Newly Diagnosed Paediatric and Adolescent Cancer Patients
Status: RECRUITING
Status Verified Date: 2022-11
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: PREDICT
Brief Summary: Assessment of the utility of family-based trio whole-genome sequencing for cancer predisposition testing in sequential newly diagnosed paediatric and adolescent cancer patients
Detailed Description: Cancer Predisposition Syndromes CPS caused by germline mutations in cancer predisposition genes CPG are heritable disorders associated with an increased risk of developing certain types of cancer

Knowledge of CPG will advance the understanding of tumorigenesis improve patient care and facilitate genetic counselling of patients and families But the prevalence of CPS in Australian children with cancer and the psychosocial impact of germline sequencing to identify CPG have not been studied

The clinical benefit of family-based WGS in every new child with cancer compared with conventional predictive factors is currently unknown By testing every child with newly diagnosed cancer the aim is to determine the utility of this approach and its impact on participants and families

The principal objective of the proposed multicentre prospective study is establish the clinical benefit and utility of family-based WGS to identify underlying CPS in every newly diagnosed child with cancer

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