Biomarkers for Clinical Hypoxia Evaluation in Cervical Cancer

Cervical Cancer Clinical Trial

— Bio-CHECC  

Official title:

Biomarkers for Clinical Hypoxia Evaluation in Cervical Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05029258
• Other study ID #: 20_DOG01_181
• Status: Recruiting
• Start date: December 10, 2020
• Est. completion date: October 31, 2024

Study information

• Verified date: November 2022
• Source: University of Manchester
• Contact: Anubhav Datta, MBChB, FRCR
• Phone: +44161 446 3658
• Email: anubhav.datta[@]manchester.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Hypoxia
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Biopsy of tumour
Cervical tumour biopsy during treatment. This will be used for gene expression (RNA) analysis against a hypoxia associated gene signature.

Diagnostic Test:
• MRI scans
Multiple magnetic resonance imaging (MRI) scans before and during treatment using oxygen enhanced (OE) / tissues oxygen level dependent (TOLD) sequence

Locations

Country	Name	City	State
United Kingdom	The Christie NHS Foundation Trust	Manchester	Greater Manchester

Sponsors (2)

Lead Sponsor	Collaborator
University of Manchester	The Christie NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI derived hypoxia scores on 20 participants	20 patients will undergo functional imaging (hypoxia MRI) at baseline. Following this, serial measurements will be taken on a weekly basis during the first 5 weeks of chemoradiation. The imaging and biopsy cohorts are the same.	2 years
Primary	Gene signature derived hypoxia scores on the same 20 participants.	Investigators will collect paired biopsies at diagnosis and at brachytherapy in 20 locally advanced cervical cancer patients. The imaging and biopsy cohorts are the same.	2 years