Cervix: Hypoxia, Interstitial Fluid Pressure and GSH Levels
Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and GSH Levels
1 other identifier
interventional
346
1 country
1
Brief Summary
The aim of this study is to measure the oxygen content and interstitial fluid pressure in cervix cancer patients. Tumour oxygen content and internal pressure of tumours may be an important factor that influences the effectiveness of radiotherapy and other treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 1995
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1995
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 6, 2026
March 1, 2026
32 years
September 12, 2005
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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
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.
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
Secondary Outcomes (1)
To determine if whole cell or nuclear GSH levels are correlated with tumour oxygen tension and with tumour response and control.
follow-up every 3 months for 2 years; every 4-6 months during year 3 to 5; and annually thereafter
Study Arms (1)
Pre-treatment tumour oxygen measurements (under anesthesia)
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Newly diagnosed patients with carcinoma of the cervix ( 3 cm in size or larger) where an examination under anesthesia is to be performed for staging purposes
- Informed consent
You may not qualify if:
- Patients with clinically occult cervix carcinoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Health Network, Torontolead
- Canadian Cancer Trials Groupcollaborator
- Princess Margaret Hospital, Canadacollaborator
Study Sites (1)
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael F Milosevic
Princess Margaret Hospital, Canada
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 16, 2005
Study Start
December 1, 1995
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
March 6, 2026
Record last verified: 2026-03