Cervix:Hypoxia, Interstitial Fluid Pressure and GSH Levels

This study is currently recruiting participants.

Verified by University Health Network, Toronto, September 2005

First Received: September 12, 2005 No Changes Posted

Sponsors and Collaborators:	University Health Network, Toronto National Cancer Institute of Canada Princess Margaret Hospital, Canada
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00188539

Purpose

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.

Condition	Intervention	Phase
Cervix Neoplasms	Procedure: Pre-treatment tumour oxygen measurements (under anesthesia)	Phase II

MedlinePlus related topics: Cancer Cervical Cancer Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and GSH Levels

Further study details as provided by University Health Network, Toronto:

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.

Estimated Enrollment:	300
Study Start Date:	December 1995

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188539

Contacts

Contact: Anthony Fyles, MD

416-946-6522

anthony.fyles@rmp.uhn.on. ca

Locations

Canada, Ontario
Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Anthony Fyles, MD 416-946-6522 anthony.fyles@rmp.uhn.on. ca

Sponsors and Collaborators

University Health Network, Toronto

National Cancer Institute of Canada

Princess Margaret Hospital, Canada

Investigators

Principal Investigator:

Anthony Fyles, MD

Princess Margaret Hospital, Canada

More Information

No publications provided

Study ID Numbers:	UHN REB 01-0376-C, National Cancer Inst of Canada
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00188539 History of Changes
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Genital Neoplasms, Female

Anesthetics
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms

Additional relevant MeSH terms:

Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Neoplasms
Neoplasms by Site

Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009