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Cancer Predisposition Testing by Family-based Whole-genome Sequencing (WGS) in Every Child With Newly Diagnosed Cancer (PREDICT)

S

Sydney Children's Hospitals Network

Status

Enrolling

Conditions

Neoplastic Syndromes, Hereditary
Genetic Predisposition to Disease
Cancer

Treatments

Diagnostic Test: Family-based whole genome sequencing

Study type

Observational

Funder types

Other

Identifiers

NCT04903782
PREDICT

Details and patient eligibility

About

Assessment of the utility of family-based (trio) whole-genome sequencing for cancer predisposition testing in sequential newly diagnosed paediatric and adolescent cancer patients

Full 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.

Enrollment

270 estimated patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  • New diagnosis of malignancy
  • Age ≤ 21 years
  • Written informed consent

Psychosocial component:

  • Participants (≥ 12 years)
  • Parent/caregiver(s) of participants
  • Healthcare professionals involved in the care of patients enrolled in the study

Trial design

270 participants in 1 patient group

Children and adolescents with newly diagnosed malignancy
Treatment:
Diagnostic Test: Family-based whole genome sequencing

Trial contacts and locations

3

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Central trial contact

Clinical Trials Manager

Data sourced from clinicaltrials.gov

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