- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00188539
Cervix:Hypoxia, Interstitial Fluid Pressure and GSH Levels
March 12, 2024 updated by: University Health Network, Toronto
Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and GSH Levels
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Phase 2
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
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- 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:
- 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
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: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pre-treatment tumour oxygen measurements (under anesthesia)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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.
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
|
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 Measures
Outcome Measure |
Time Frame |
---|---|
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
|
follow-up every 3 months for 2 years; every 4-6 months during year 3 to 5; and annually thereafter
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Anthony Fyles, MD, Princess Margaret Hospital, Canada
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
December 1, 1995
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimated)
September 16, 2005
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 12, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Signs and Symptoms, Respiratory
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
- Hypoxia
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics
Other Study ID Numbers
- UHN REB 01-0376-C
- National Cancer Inst of Canada
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
Clinical Trials on Cervix Neoplasms
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All India Institute of Medical Sciences, New DelhiUnknownMetastatic Carcinoma to the Uterine Cervix | Recurrent Carcinoma Cervix | Cervix Carcinoma RecurrentIndia
-
Tata Memorial HospitalCompletedCervical Cancer | Cervix Cancer | Cancer of Cervix | Cancer of the CervixIndia
-
UNC Lineberger Comprehensive Cancer CenterNot yet recruitingCervix Cancer | Cervix Intraepithelial Neoplasia Grade 3 | Cervix; Intraepithelial Neoplasia, Grade I | Cervix; Intraepithelial Neoplasia, Grade IIKenya
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PATHAshonplafa; Ministry of Health, HondurasCompleted
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University of RochesterCompletedCervix NeoplasmUnited States
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Abramson Cancer Center of the University of PennsylvaniaCompletedUterine Cervix CancerUnited States
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Laboratorio Elea Phoenix S.A.CompletedSquamous Cell Carcinoma of the Cervix | Adenocarcinoma of the CervixArgentina
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-
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