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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-08

Study Completion Date

2028-06-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Neoplastic Syndromes, Hereditary Cancer Genetic Predisposition to Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children and adolescents with newly diagnosed malignancy

Family-based whole genome sequencing

Intervention Type DIAGNOSTIC_TEST

1. Germline whole-genome family-based sequencing and variant identification.
2. Multidisciplinary Meeting case discussion.
3. Recommendation of referral to a Cancer Genetics Clinic for further investigation, follow up and/or genetic counselling.
4. Psychosocial study to analyse the impact of germline sequencing on families.

Interventions

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Family-based whole genome sequencing

1. Germline whole-genome family-based sequencing and variant identification.
2. Multidisciplinary Meeting case discussion.
3. Recommendation of referral to a Cancer Genetics Clinic for further investigation, follow up and/or genetic counselling.
4. Psychosocial study to analyse the impact of germline sequencing on families.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion 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

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No