Clinical trial NCT05029258: Biomarkers for Clinical Hypoxia Evaluation in Cervical Cancer
Official title: Biomarkers for Clinical Hypoxia Evaluation in Cervical Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Keywords: Hypoxia
Radiotherapy
Gene expression
Imaging
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: The Christie NHS Foundation Trust
First posted: 2021-08-31
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Locally advanced cervical cancer patients

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: MRI derived hypoxia scores on 20 participants
timeFrame: 2 years
measure: Gene signature derived hypoxia scores on the same 20 participants.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
state: Greater Manchester
Study officials:
References: