NCT06787053 Selecting Hypoxic Tumours for Treatment Modification
| NCT ID | NCT06787053 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Manchester |
| Condition | Bladder (Urothelial, Transitional Cell) Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-10-16 |
| Primary Completion | 2028-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-10-16 with a primary completion date of 2028-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Approximately 50% of cancer patients with solid tumours will be treated with radiotherapy. A significant proportion (\>25%) of patients have hypoxic tumours which respond poorly to radiotherapy. Hypoxic tumours have a poor prognosis. This can be improved with treatment intensification. Treatment intensification can be modification with CON (breathing O2-enriched air + oral administration of nicotinamide), chemoradiosensitisation, radiation dose-escalation or additional systemic treatments, significantly improving response of the tumours to radiotherapy. However, there are currently no clinically approved biomarkers to identify hypoxic tumours. Our group has developed and validated gene-expression signature-based biomarkers that identify patients with hypoxic bladder, head and neck , prostate, sarcoma and lung cancers. The bladder cancer gene-expression hypoxia signature has been shown to predict benefit from hypoxia modification using RNA from archived tumour tissue. The main purpose of this study is to demonstrate in at least two cancer types that the hypoxia biomarker predicts benefit from hypoxia modification in real-time.
Eligibility Criteria
Inclusion Criteria: This will be tumour site dependent. Bladder: * Older than age 18 years. * Patients having radiotherapy at the Christie NHS Foundation Trust suitable for imaging on an MRI scanner. * Able to give informed consent. Cervix: * Older than age 18 years. * Patients having radiotherapy at the Christie NHS Foundation Trust suitable for imaging on an MRI scanner. * Able to give informed consent. Prostate: * Older than age 18 years. * Patients having radiotherapy at the Christie NHS Foundation Trust suitable for imaging on an MRI scanner. * Able to give informed consent. Exclusion Criteria: This will be tumour site dependent Bladder: * Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form. * Unable to tolerate MRI scans. * Pregnancy. Cervix: * Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form. * Unable to tolerate MRI scans. * Pregnancy. Prostate: * Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form. * Unable to tolerate MRI scans
Contact & Investigator
Ananya Choudhury, Professor
PRINCIPAL INVESTIGATOR
University of Manchester
Frequently Asked Questions
Who can join the NCT06787053 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder (Urothelial, Transitional Cell) Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06787053 currently recruiting?
Yes, NCT06787053 is actively recruiting participants. Contact the research team at rachel.reed@manchester.ac.uk for enrollment information.
Where is the NCT06787053 trial being conducted?
This trial is being conducted at Manchester, United Kingdom.
Who is sponsoring the NCT06787053 clinical trial?
NCT06787053 is sponsored by University of Manchester. The principal investigator is Ananya Choudhury, Professor at University of Manchester. The trial plans to enroll 30 participants.
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