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Cervix:Hypoxia, Interstitial Fluid Pressure and GSH Levels

Primary Purpose

Cervix Neoplasms

Status
Active
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Pre-treatment tumour oxygen measurements (under anesthesia)
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervix Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Patients with clinically occult cervix carcinoma

Sites / Locations

  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pre-treatment tumour oxygen measurements (under anesthesia)

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

To determine if whole cell or nuclear GSH levels are correlated with tumour oxygen tension and with tumour response and control.

Full Information

First Posted
September 12, 2005
Last Updated
April 5, 2023
Sponsor
University Health Network, Toronto
Collaborators
Canadian Cancer Trials Group, Princess Margaret Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00188539
Brief Title
Cervix:Hypoxia, Interstitial Fluid Pressure and GSH Levels
Official Title
Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and GSH Levels
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1995 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Canadian Cancer Trials Group, Princess Margaret Hospital, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-treatment tumour oxygen measurements (under anesthesia)
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Pre-treatment tumour oxygen measurements (under anesthesia)
Primary Outcome Measure Information:
Title
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.
Time Frame
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
Title
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.
Time Frame
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 Outcome Measure Information:
Title
To determine if whole cell or nuclear GSH levels are correlated with tumour oxygen tension and with tumour response and control.
Time Frame
follow-up every 3 months for 2 years; every 4-6 months during year 3 to 5; and annually thereafter

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients with clinically occult cervix carcinoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Fyles, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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Cervix:Hypoxia, Interstitial Fluid Pressure and GSH Levels

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