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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Peter
Hoskin
peter.hoskin@manchester.ac.uk
Prof
PETER
HOSKIN
anubhav.datta@manchester.ac.uk
Malignant neoplasms of female genital organs
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Hypoxia (low oxygen level) within solid tumours is related to poorer outcomes for patients. These tumours also demonstrate a resistance to radiotherapy, and higher doses are required to reach the same level of disease control. This makes therapy challenging and is a particular problem in cervical cancer which is primarily treated with radiation.
A possible way to increase the effects of radiotherapy on the tumour is to use hypoxia modifying medications. We know these medications show the greatest benefit in the most hypoxic tumours, however there is no proven strategy to identify these patients. Biological markers (biomarkers) specific to hypoxia can be used to inform clinicians about the various pathways in the body. Two candidate biomarkers with the greatest promise are derived from gene testing and magnetic resonance imaging (MRI) methods. The study will combine data from these two methods and aims to guide future research in this area.
Patients enrolled in the study will continue with the standard of care therapy as prescribed by the clinician responsible for their treatment. This is a basic science study that will observe the impact of radiotherapy on the genetic and MRI derived biomarkers during treatment.
Patients will be enrolled in the study for 3 months during which they will undergo serial imaging and two biopsy samples alongside their treatment. The study is recruiting patients older than the age of 18, diagnosed with cervical cancer and have not started therapy, and are not pregnant. An additional biopsy and MRI will be offered at 12 months if deemed necessary by the lead clinician. All treatment and research will be conducted on The Christie Hospital NHS Trust site.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Validation of investigation /therapeutic procedures;
You can take part if:
You may not be able to take part if:
Principle exclusion criteria for all participants in retrospective study: 1. Any recurrent tumours. 2. Any previous radiotherapy. 3. Any previous chemotherapy. Principle exclusion criteria for all participants in prospective study: 1. Patients with cardiac pacemakers, cochlear implants, intraocular foreign bodies or any other MR contraindication. 2. Patients with a hip replacement. 3. Patients with a known history of allergic reaction to gadolinium-based contrast agent. 4. Any patient taking ACE inhibitors. These should be stopped/substituted, or they are a contraindication. 5. Evidence of impaired renal function (eGFR < 15 ml/min). 6. Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the participant to participate in the trial. 7. Any other serious uncontrolled medical conditions. 8. Any pregnant or lactating woman. Specific exclusion criteria for patient participants: 1. Participants deemed unsuitable for a biopsy (during or following radiotherapy) in the opinion of the treating oncologist. 2. 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 trial. 3. Clinical evidence of metastatic disease 4. Any patient with a medical or psychiatric condition that impairs their ability to give informed consent. 5. Any patient who is currently involved in, or who has recently been involved in other research.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University of Manchester and funded by CANCER RESEARCH UK .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 46886
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