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Cervix:Hypoxia, Interstitial Fluid Pressure and GSH Levels

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00188539
First Posted: September 16, 2005
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Canadian Cancer Trials Group
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
  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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and GSH Levels

Resource links provided by NLM:


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. [ 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 ]
  • 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 Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: December 1995
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pre-treatment tumour oxygen measurements (under anesthesia) Procedure: Pre-treatment tumour oxygen measurements (under anesthesia)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188539


Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Canadian Cancer Trials Group
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Anthony Fyles, MD Princess Margaret Hospital, Canada
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00188539     History of Changes
Other Study ID Numbers: UHN REB 01-0376-C
National Cancer Inst of Canada
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: September 22, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Hypoxia
Uterine Cervical Neoplasms
Signs and Symptoms, Respiratory
Signs and Symptoms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs