Predictive Assays In Cervix Cancer
March 3, 2026 updated by: University Health Network, Toronto
Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and Tissue and Plasma Biomarkers of Hypoxia (CXTF10)
The experiments outlined in this proposal will compare a number of currently available techniques for assessing hypoxia and interstitial fluid pressures in patients with cervix cancer.
The aim of these experiments is to establish the relationship of the clinically relevant outcome measures of tumour control and survival following radiation therapy with these biological characteristics of carcinoma of the cervix relevant to tumour hypoxia.
These characteristics will be assessed in patients undergoing treatment using techniques which have reached an appropriate level of development for clinical evaluation and aim to determine the best technique for determining these parameters of the tumour microenvironment.
A number of novel strategies directed at the microenvironment are undergoing or soon will be undergoing clinical evaluation and selection of appropriate patients for these trials is of great importance.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- University Health Network, Princess Margaret Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Histologic diagnosis of cervix cancer
- A decision to treat using radiation therapy according to the existing treatment policies of the PMH Gynecology Group
- Clinical stage IB-IV with grossly evident cervical disease
- No distant metastases
- No cytotoxic anti-cancer therapy for cervical carcinoma prior to study entry
- Signed informed consent
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Assays on cervical cancer tissue
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Patients who consent to the tissue part of this study will have Biopsies taken for study purposes at the same time as their routine tumour biopsies .
In addition,those who consent to the blood sampling part of the study will have their samples taken assess serum biomarkers of tumour oxygenation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To understand the mechanisms by which hypoxia and IFP influence disease progression, and response to radiotherapy, chemotherapy and other novel biologically-targeted therapies in patients with cervix cancer.
Time Frame: 3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.
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3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine if tissue biomarkers of hypoxia are independent prognostic factors for relapse and survival in patients with cervix cancer.
Time Frame: 3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.
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3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.
|
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To determine if plasma biomarkers of hypoxia are independent prognostic factors for relapse and survival in patients with cervix cancer.
Time Frame: 3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.
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3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.
|
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To assess the heterogeneity of tissue biomarkers of hypoxia in multiple biopsies from cervix cancers.
Time Frame: 3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.
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3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michael Milosevic, MD, University Health Network, Princess Margaret Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2006
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Study Registration Dates
First Submitted
August 12, 2010
First Submitted That Met QC Criteria
August 12, 2010
First Posted (Estimated)
August 13, 2010
Study Record Updates
Last Update Posted (Actual)
March 5, 2026
Last Update Submitted That Met QC Criteria
March 3, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Uterine Diseases
- Genital Diseases, Female
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Signs and Symptoms, Respiratory
- Uterine Neoplasms
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Hypoxia
- Uterine Cervical Neoplasms
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Blood Specimen Collection
Other Study ID Numbers
- 06-0379
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.