Cancer ChildhoodUF-WGSNCT07201038
Ultrafast Whole Genome Sequencing for Childhood Cancer
An observational study of Cancer Childhood, run by University of Cambridge at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 24 years
- Conditions the study is for
- Cancer Childhood
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Oct 2022to 17 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with cancer at relapse or initial diagnosis
Who may be able to join
- Have given written informed consent to participate
- Be aged <25 years of age
- Have confirmed or suspected malignancy
- 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
Who cannot join
- Inability to provide written informed consent (self or parent/guardian)
- Insufficient tissue (BM/PB/tissue) available for research purposes after collection for routine diagnostic purposes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Addenbrookes Hospital
Cambridge
About this study
Official title: Feasibility of Ultrafast WGS in Paediatric Malignancies
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.
- Conditions
- Cancer Childhood
- Keywords
- whole genome sequencing
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ultrafast WGS cohort, prospective patients | Not described | |
| Ultrafast WGS, retrospective patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turnaround time from sample collection to availability of meaningful results.
Measured: 36 months
Secondary outcomes (2)
Percentage of enrolled patients with available WGS results from the Ultrafast WGS pipeline.
Measured: 24 months
Correlation of data from Ultrafast WGS against current SOC WGS data.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start19 Oct 2022
- Primary completion18 Oct 2027 (estimated)
- Study completion17 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Illumina, Inc., Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Aditi Vedi, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201038
- Sponsor's protocol ID
- IRAS317008
- Acronym
- UF-WGS
- Status last verified
- Mar 2026
- First submitted
- 23 Sep 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Ultrafast WGS in Paediatric Malignancies
- ClinicalTrials.gov ID
- NCT07201038
- Acronym / sponsor ID
- UF-WGS / IRAS317008
- Conditions
- Cancer Childhood
- Keywords
- whole genome sequencing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Illumina, Inc., Cambridge University Hospitals NHS Foundation Trust
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 18 Oct 2027 (estimated)
- Study completion
- 17 Oct 2028 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrafast WGS cohort, prospective patients | – | – |
| Ultrafast WGS, retrospective patients | – | – |
Who may qualify
- Ages
- 0 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with cancer at relapse or initial diagnosis
Key inclusion criteria (5 listed)
- Have given written informed consent to participate
- Be aged <25 years of age
- Have confirmed or suspected malignancy
- 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
Key exclusion criteria (2 listed)
- Inability to provide written informed consent (self or parent/guardian)
- Insufficient tissue (BM/PB/tissue) available for research purposes after collection for routine diagnostic purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Turnaround time from sample collection to availability of meaningful results.
Time frame: 36 months
2 secondary outcomes
Percentage of enrolled patients with available WGS results from the Ultrafast WGS pipeline.
Time frame: 24 months
Correlation of data from Ultrafast WGS against current SOC WGS data.
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Childhood, run by University of Cambridge at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria Joslin (01223217251, vicky.joslin@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turnaround time from sample collection to availability of meaningful results. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.