Evaluating biomarkers for hypoxia in cervical cancer treatment
Biomarkers for Clinical Hypoxia Evaluation in Cervical Cancer
This study is testing if certain genetic and imaging markers can help doctors choose the best treatment for patients with advanced cervical cancer who are receiving radiotherapy, focusing on the effects of low oxygen levels in tumors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Manchester Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Manchester, Greater Manchester) |
| Trial ID | NCT05029258 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with locally advanced cervical cancer who are undergoing radiotherapy, with the aim of identifying genetic and imaging biomarkers that can help optimize patient selection for hypoxia modification therapies. Given that hypoxia is a significant factor in the radioresistance of cervical tumors, the study seeks to validate biomarkers that can stratify patients based on their tumor's hypoxic status. By examining both biopsy samples and MRI scans, the research aims to improve treatment outcomes and reduce toxicity associated with current therapies. The study is conducted at The Christie NHS Foundation Trust in Manchester.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with a histologically confirmed diagnosis of cervical cancer who are suitable for standard radiotherapy and brachytherapy.
Not a fit: Patients who are unsuitable for biopsy or have contraindications for MRI scans will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and survival rates for patients with cervical cancer by enabling more personalized therapy based on tumor hypoxia.
How similar studies have performed: While there is ongoing research into hypoxia modification therapies, this study aims to validate specific biomarkers for cervical cancer, making it a novel approach in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * 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. Exclusion criteria: * Participants deemed unsuitable for a biopsy (during or following radiotherapy) in the opinion of the treating oncologist. * Patients with cardiac pacemakers, cochlear implants, intraocular foreign bodies or any other MR contraindication * Patients with a hip replacement * Patients with a known history of allergic reaction to gadolinium-based contrast agent * Any contraindications to Hyoscine Butylbromide (Buscopan) * Any patient taking ACE inhibitors. These should be stopped/substituted or they are a contraindication. * Evidence of impaired renal function (eGFR \<15 ml/min) * 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 * 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 * Any other serious uncontrolled medical conditions * Clinical evidence of metastatic disease * Any pregnant or lactating woman * Any patient with a medical or psychiatric condition that impairs their ability to give informed consent * Any patient who is currently involved in, or who has recently been involved in other research
Where this trial is running
Manchester, Greater Manchester
- The Christie NHS Foundation Trust — Manchester, Greater Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Rachel Reed, MSc
- Email: rachel.reed@manchester.ac.uk
- Phone: 01619187029
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.