Biomarkers for Clinical Hypoxia Evaluation in Cervical Cancer
Bio-CHECC
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2020
CompletedFirst Submitted
Initial submission to the registry
August 19, 2021
CompletedFirst Posted
Study publicly available on registry
August 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
January 20, 2025
January 1, 2025
6.9 years
August 19, 2021
January 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (1)
Locally advanced cervical cancer patients treated with standard of care chemoradiation
Interventions
Cervical tumour biopsy during treatment. This will be used for gene expression (RNA) analysis against a hypoxia associated gene signature.
Multiple magnetic resonance imaging (MRI) scans before and during treatment using oxygen enhanced (OE) / tissues oxygen level dependent (TOLD) sequence
Eligibility Criteria
Locally advanced cervical cancer patients
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manchesterlead
- The Christie NHS Foundation Trustcollaborator
Study Sites (1)
The Christie NHS Foundation Trust
Manchester, Greater Manchester, M20 4BX, United Kingdom
Biospecimen
Biopsy specimens retained
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Clinical Oncology, Principal Investigator
Study Record Dates
First Submitted
August 19, 2021
First Posted
August 31, 2021
Study Start
December 10, 2020
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
October 31, 2027
Last Updated
January 20, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share