NCT05029258Active, not recruiting
Biomarkers for Clinical Hypoxia Evaluation in Cervical Cancer
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
Patients with locally advanced cervical cancer (LACC) are primarily treated with radiotherapy +/- chemotherapy however 5-year survival rates are \<60% with significant treatment toxicity. Hypoxia is a well-known radioresistant component of solid tumours such as cervical cancer and hypoxia modification therapies have demonstrated immense promise in treating such tumours. A major factor in determining a successful outcome with hypoxia modification is appropriate patient selection as it is hypoxic tumours that receive the most benefit from hypoxia modifying therapies. To date there is no validated hypoxia biomarker to stratify patients for therapy in cervical cancer in clinical use. This project offers a unique opportunity to examine both genetic and imaging biomarkers to optimise patient stratification when receiving curative radiotherapy for cervical cancer.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 19 Aug 2021
- Start date
- 10 Dec 2020
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- University of Manchester
- Diseases
- Cervical cancer
- NCT number
- NCT05029258
What you commit to
- Study type: Observational
- Planned participants: 30
- From 10 Dec 2020 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants deemed unsuitable for a biopsy (during or following radiotherapy) in the opinion of the treating oncologist.
- Any patient taking ACE inhibitors. These should be stopped/substituted or they are a contraindication.
Other illness
- Patients with cardiac pacemakers, cochlear implants, intraocular foreign bodies or any other MR contraindication
- Patients with a known history of allergic reaction to gadolinium-based contrast agent
- Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the study
- Any other serious uncontrolled medical conditions
- Clinical evidence of metastatic disease
- Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
Lab values
- Evidence of impaired renal function (eGFR \<15 ml/min)
- Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the study
Other
- Patients with a hip replacement
- Any contraindications to Hyoscine Butylbromide (Buscopan)
- Any pregnant or lactating woman
- Any patient who is currently involved in, or who has recently been involved in other research
Who the study is looking for
- Patients must have a histologically confirmed diagnosis of cervical cancer
- Diagnostic/pre-treatment biopsy available
- Patients must be suitable for standard radiotherapy and brachytherapy
- Age greater than or equal to 18 years; no upper age limit
- Performance status - ECOG 0-2 (Refer to appendix 1)
- Women of childbearing age MUST have a negative pregnancy test prior to study entry and be using an adequate contraception method
- Before participant registration, written informed consent must be given according to GCP and national regulations.
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.