NCT04903782

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Mar 2021Jun 2028

Study Start

First participant enrolled

March 8, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2023

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2028

Expected
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

March 16, 2021

Last Update Submit

November 2, 2022

Conditions

Neoplastic Syndromes, HereditaryCancerGenetic Predisposition to Disease

Keywords

Germ-line MutationDisease SusceptibilityChildPediatricsGenomicsNext Generation SequencingRisk

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients with CPS identify by WGS as compared to those correctly identified by clinical information (i.e. family history, tumour type, physical findings).

    2 years

Secondary Outcomes (11)

  • The proportion of individuals found to have a reportable germline mutation in a CPG

    2 years

  • The proportion of patients who have de-novo vs. inherited mutation in CPG.

    2 years

  • Turnaround time for issuing a report to the treating clinician.

    2 years

  • The proportion of participants with a complete recording of family history of cancer.

    2 years

  • Sensitivity and specificity of WGS versus single/multiple gene panel testing guided by clinical predictive factors.

    2 years

  • +6 more secondary outcomes

Study Arms (1)

Children and adolescents with newly diagnosed malignancy

Diagnostic Test: Family-based whole genome sequencing

Interventions

Family-based whole genome sequencingDIAGNOSTIC_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.

Children and adolescents with newly diagnosed malignancy

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Paediatric patients who are being treated for a newly diagnosed cancer in New South Wales, Australia

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

John Hunter Children's Hospital

Newcastle, New South Wales, 2305, Australia

RECRUITING

Sydney Children's Hospital

Sydney, New South Wales, 2031, Australia

RECRUITING

The Children's Hospital at Westmead

Sydney, New South Wales, 2145, Australia

RECRUITING

Related Publications (1)

  • Fuentes Bolanos NA, Padhye B, Daley M, Hunter J, Hetherington K, Warby M, Courtney E, Kirk J, Josephi-Taylor S, Chen Y, Alvaro F, Barlow-Stewart K, Wong-Erasmus M, Barahona P, Ajuyah P, Altekoester AK, Tyrrell VJ, Lau LMS, Wakefield C, Sylvester D, Tucker K, Pinese M, Dalla Pozza L, O'Brien TA. Protocol for a comprehensive prospective cohort study of trio-based whole-genome sequencing for underlying cancer predisposition in paediatric and adolescent patients newly diagnosed with cancer: the PREDICT study. BMJ Open. 2023 May 30;13(5):e070082. doi: 10.1136/bmjopen-2022-070082.

    PMID: 37253493DERIVED

MeSH Terms

Conditions

Neoplastic Syndromes, HereditaryNeoplasmsGenetic Predisposition to DiseaseDisease Susceptibility

Condition Hierarchy (Ancestors)

Genetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Trials Manager

CONTACT

+61 2 9382 3122SCHN-PREDICT@health.nsw.gov.au

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 16, 2021

First Posted

May 27, 2021

Study Start

March 8, 2021

Primary Completion

March 8, 2023

Study Completion (Estimated)

June 15, 2028

Last Updated

November 4, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(3)