ClinicalTrials.gg
RecruitingNCT07201038UF-WGSUpdated Mar 17, 2026

Ultrafast Whole Genome Sequencing for Childhood Cancer

An observational study in Cancer Childhood, sponsored by University of Cambridge. Recruiting at 1 site in United Kingdom. Open to participants aged 0 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-03-17.

Sponsored by University of Cambridge · Observational

From the registry’s dates

  • Started Oct 2022; still recruiting 4 years later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
0 Years to 24 Years
Sex
All
01

Study summary

Cambridge University Hospitals NHS Foundation Trust (CUHNFT) is the Principal Treatment Centre for the East of England region, responsible for 120-150 patients \<16 years with a new diagnosis of paediatric malignancy annually; leukaemia comprises \~25% of these cases. Current molecular diagnosis of subgroups of childhood malignancies, particularly leukaemia, is based on flow cytometry, fluorescent in situ hybridisation (FISH) and single nucleotide polymorphim (SNP) arrays, for which the usual turnaround time (TAT) is 7-14 days. In the current era of access to targeted therapy, rapid diagnosis and treatment of patients in high-risk molecular subgroups is critical for improving outcomes. Children and adolescents with Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) have significantly improved survival when treated with tyrosine kinase inhibitors (TKIs). Patients with Ph+-like mutations (10- 20% of paediatric ALL), also have a poor prognosis, requiring escalation of treatment and addition of targeted therapy. Rapidly identifying MYCN amplification is also of critical prognostic importance in embryonal tumours of childhood including neuroblastoma (25%) and medulloblastoma, and directly impacts on treatment from the outset of the patient journey. Overnight whole genome sequencing (WGS) entails taking an additional 5ml Peripheral Blood (PB) and Bone Marrow (BM) samples after samples for routine diagnostic workup have been collected, and could replace current standard of care (SOC), which has a median turnaround time (TAT) of up to 28 days, and up to 84 days for specific gene mutations, which can delay appropriate prognostication and management of high-risk patients. Rapid, point of care information on somatic and germline mutations will allow early risk stratification and expedite treatment for high-risk patients with cancer.

02

Conditions studied

  • Cancer Childhood

Browse trials for

Keywords

  • whole genome sequencing
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 50 is below the median of 200 across 2,638 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University of Cambridge is the lead sponsor of 116 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children with cancer at relapse or initial diagnosis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have given written to participate
  • Be aged \<25 years of age
  • Have confirmed or suspected
  • For pilot/feasibility study (first 10 patients), only haematological malignancies (ALL/AML) will be included
  • Have tumour and germline sample available - retrospectively collected or for prospective collection

Exclusion criteria

Exclusion Criteria:

  • Inability to provide written (self or parent/guardian)
  • Insufficient tissue (BM/PB/tissue) available for research purposes after collection for routine diagnostic purposes
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Ultrafast WGS cohort, prospective patients
  • Ultrafast WGS, retrospective patients
06

What researchers measure

Primary outcomes

  1. Turnaround time from sample collection to availability of meaningful results.

    Time frame: 36 months

Secondary outcomes

  1. Percentage of enrolled patients with available WGS results from the Ultrafast WGS pipeline.

    Time frame: 24 months

  2. Correlation of data from Ultrafast WGS against current SOC WGS data.

    Time frame: 36 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07201038
Responsible party
Aditi Vedi (Chief Investigator, University of Cambridge) — Principal investigator
First posted
Oct 1, 2025
Start date
Oct 19, 2022
Primary completion
Oct 18, 2027 (estimated)
Completion
Oct 17, 2028 (estimated)
Last update
Mar 17, 2026

Study contacts

Victoria Joslin
Contact
vicky.joslin@nhs.net
01223217251

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion