NCT06820294

Brief Summary

This retrospective case series reviews clinical notes to assess whether NHS whole genome sequencing provides tangible benefits for paediatric tumours.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress80%
Sep 2022Mar 2027

Study Start

First participant enrolled

September 22, 2022

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

4.5 years

First QC Date

February 5, 2025

Last Update Submit

February 5, 2025

Conditions

CancerPediatric CancerNeoplasm

Outcome Measures

Primary Outcomes (1)

  • The proportion of children clinically benefiting from whole genome sequencing

    The proportion of children clinically benefiting from whole genome sequencing in terms of improving diagnoses, treatment, and prognostication, amongst other aspects

    5.5 years

Secondary Outcomes (1)

  • Relation between mutation data and disease phenotypes

    5.5 years

Other Outcomes (1)

  • The cost of whole genome sequencing

    5.5 years

Study Arms (1)

All children/young people (up to 21years) diagnosed with neoplastic disorder who have had NHSE WGS

All children and young people (up to the age of 21 years) diagnosed with a neoplastic disorder who have been offered NHSE whole genome sequencing.

Other: No intervention

Interventions

No interventionOTHER

As per widely adopted clinical research practice for case reviews of de-identified, anonymised data, no explicit consent of participants (or their legal guardians) would be required for this study other than the consent they provided at biopsy (from which the whole genome sequencing data is derived) for researchers to access their notes (as documented on hospital consent form).

All children/young people (up to 21years) diagnosed with neoplastic disorder who have had NHSE WGS

Eligibility Criteria

Age0 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All children and young people (up to the age of 21 years) diagnosed with a neoplastic disorder

You may qualify if:

  • All children and young people (up to the age of 21 years) diagnosed with a neoplastic disorder who have been offered NHSE whole genome sequencing.

You may not qualify if:

  • Anyone not offered NHSE whole genome sequencing
  • Individuals beyond the age of 21
  • Individuals without a neoplastic disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wellcome Sanger Institute

Cambridge, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 11, 2025

Study Start

September 22, 2022

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

February 11, 2025

Record last verified: 2025-02

Locations

GB(1)