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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04903782




Registration number
NCT04903782
Ethics application status
Date submitted
16/03/2021
Date registered
27/05/2021

Titles & IDs
Public title
Cancer Predisposition Testing by Family-based Whole-genome Sequencing (WGS) in Every Child With Newly Diagnosed Cancer
Scientific 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
Secondary ID [1] 0 0
PREDICT
Universal Trial Number (UTN)
Trial acronym
PREDICT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplastic Syndromes, Hereditary 0 0
Cancer 0 0
Genetic Predisposition to Disease 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Inflammatory and Immune System 0 0 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Family-based whole genome sequencing

Children and adolescents with newly diagnosed malignancy -


Diagnosis / Prognosis: 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 code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
The proportion of individuals found to have a reportable germline mutation in a CPG
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
The proportion of patients who have de-novo vs. inherited mutation in CPG.
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Turnaround time for issuing a report to the treating clinician.
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
The proportion of participants with a complete recording of family history of cancer.
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Sensitivity and specificity of WGS versus single/multiple gene panel testing guided by clinical predictive factors.
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
The proportion of participants with CPS who undergo cancer surveillance.
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Test the significance of common cancer risk polymorphisms within a family as a contributing factor in cancer incidence.
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
Quantify the frequency of rare noncoding, complex, and oligogenic variation (in units of variants/person, and genes with variants/person), as detected by WGS, in a paediatric cancer population relative to cancer-free parents and population controls.
Timepoint [8] 0 0
2 years
Secondary outcome [9] 0 0
Assess the prevalence of subclonal somatic variation (e.g. clonal haematopoiesis of indeterminate potential) in children with non-haematological cancer.
Timepoint [9] 0 0
2 years
Secondary outcome [10] 0 0
The psychological impact of the germline sequencing process, including the informed consent process, on patients and parents.
Timepoint [10] 0 0
5 years
Secondary outcome [11] 0 0
Cost of clinical model including WGS for cancer predisposition testing in every child newly diagnosed with cancer.
Timepoint [11] 0 0
5 years

Eligibility
Key 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
Minimum age
No limit
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/06/2028
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
John Hunter Children's Hospital - Newcastle
Recruitment hospital [2] 0 0
Sydney Children's Hospital - Sydney
Recruitment hospital [3] 0 0
The Children's Hospital at Westmead - Sydney
Recruitment postcode(s) [1] 0 0
2305 - Newcastle
Recruitment postcode(s) [2] 0 0
2031 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Sydney Children's Hospitals Network
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Children's Cancer Institute Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trials Manager
Address 0 0
Country 0 0
Phone 0 0
+61 2 9382 3122
Fax 0 0
Email 0 0
SCHN-PREDICT@health.nsw.gov.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04903782