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Pre-treatment tumour oxygen measurements (under anesthesia) for Cervical Cancer
Phase 2
Waitlist Available
Led By Anthony Fyles, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow-up every 3 months for 2 years; every 4-6 months during year 3 to 5; and annually thereafter
Awards & highlights
Study Summary
This trial is measuring oxygen and fluid pressure in the cervix of cancer patients to see if it affects treatment options.
Who is the study for?
This trial is for individuals newly diagnosed with cervical cancer, specifically those with tumors 3 cm or larger. Participants must be undergoing an examination under anesthesia for staging and must provide informed consent to partake in the study.Check my eligibility
What is being tested?
The study aims to measure oxygen levels and interstitial fluid pressure inside cervical cancer tumors. These measurements are taken before any treatment starts, as they may affect how well radiotherapy and other treatments work.See study design
What are the potential side effects?
Since this trial involves measurement procedures rather than drug interventions, side effects are related to the risks of anesthesia and potential discomfort from the measuring process itself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ tumour measurement will be done 2-3 months following completion of treatment; follow-up every 3 months for 2 years; every 4-6 months during year 3 to 5; and annually thereafter
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tumour measurement will be done 2-3 months following completion of treatment; follow-up every 3 months for 2 years; every 4-6 months during year 3 to 5; and annually thereafter
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To correlate tumour IFP measured before and during radiation therapy with oxygen tension as measured by the Eppendorf probe and to assess IFP as a prognostic factor for pelvic control.
To determine if tumour oxygen tension prior to and during radiation therapy is an independent prognostic factor for primary tumour response and control in patients with cervix cancer.
Secondary outcome measures
To determine if whole cell or nuclear GSH levels are correlated with tumour oxygen tension and with tumour response and control.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pre-treatment tumour oxygen measurements (under anesthesia)Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,478 Previous Clinical Trials
485,100 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
126 Previous Clinical Trials
67,742 Total Patients Enrolled
Princess Margaret Hospital, CanadaOTHER
119 Previous Clinical Trials
38,759 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Pre-treatment tumour oxygen measurements (under anesthesia)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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