Clinical trial · Observational
Selecting Hypoxic Tumours for Treatment Modification
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder (Urothelial, Transitional Cell) Cancer | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Bladder
- description
- Patients diagnosed with bladder cancer
- label
- Prostate
- description
- Patients diagnosed with prostate cancer
- label
- Cervix
- description
- Patients diagnosed with cervical cancer
Primary outcomes (1)
- measure
- Primary
- timeFrame
- Through to study completion, until May 2028
- description
- To have collected the FFPE tumour blocks and generate the gene signature.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDSwartz JE, Smits HJG, Philippens MEP, de Bree R, H A M Kaanders J, Willems SM. Correlation and colocalization of HIF-1alpha and pimonidazole staining for hypoxia in laryngeal squamous cell carcinomas: A digital, single-cell-based analysis. Oral Oncol. 2022 May;128:105862. doi: 10.1016/j.oraloncology.2022.105862. Epub 2022 Apr 18. PMID 35447566
- BACKGROUNDBatis N, Brooks JM, Payne K, Sharma N, Nankivell P, Mehanna H. Lack of predictive tools for conventional and targeted cancer therapy: Barriers to biomarker development and clinical translation. Adv Drug Deliv Rev. 2021 Sep;176:113854. doi: 10.1016/j.addr.2021.113854. Epub 2021 Jun 27. PMID 34192550
- BACKGROUNDYang L, Taylor J, Eustace A, Irlam JJ, Denley H, Hoskin PJ, Alsner J, Buffa FM, Harris AL, Choudhury A, West CML. A Gene Signature for Selecting Benefit from Hypoxia Modification of Radiotherapy for High-Risk Bladder Cancer Patients. Clin Cancer Res. 2017 Aug 15;23(16):4761-4768. doi: 10.1158/1078-0432.CCR-17-0038. Epub 2017 Apr 11. PMID 28400426
- BACKGROUNDYang L, Roberts D, Takhar M, Erho N, Bibby BAS, Thiruthaneeswaran N, Bhandari V, Cheng WC, Haider S, McCorry AMB, McArt D, Jain S, Alshalalfa M, Ross A, Schaffer E, Den RB, Jeffrey Karnes R, Klein E, Hoskin PJ, Freedland SJ, Lamb AD, Neal DE, Buffa FM, Bristow RG, Boutros PC, Davicioni E, Choudhury A, West CML. Development and Validation of a 28-gene Hypoxia-related Prognostic Signature for Localized Prostate Cancer. EBioMedicine. 2018 May;31:182-189. doi: 10.1016/j.ebiom.2018.04.019. Epub 2018 Apr 23. PMID 29729848
- BACKGROUNDLane B, Khan MT, Choudhury A, Salem A, West CML. Development and validation of a hypoxia-associated signature for lung adenocarcinoma. Sci Rep. 2022 Jan 25;12(1):1290. doi: 10.1038/s41598-022-05385-7. PMID 35079065
- BACKGROUNDForker LJ, Bibby B, Yang L, Lane B, Irlam J, Mistry H, Khan M, Valentine H, Wylie J, Shenjere P, Leahy M, Gaunt P, Billingham L, Seddon BM, Grimer R, Robinson M, Choudhury A, West C. Technical development and validation of a clinically applicable microenvironment classifier as a biomarker of tumour hypoxia for soft tissue sarcoma. Br J Cancer. 2023 Jun;128(12):2307-2317. doi: 10.1038/s41416-023-02265-3. Epub 2023 Apr 21.