Cervix:Hypoxia, Interstitial Fluid Pressure and GSH Levels

Cervix Neoplasms Clinical Trial

Official title:

Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and GSH Levels

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00188539
• Other study ID #: UHN REB 01-0376-C
• Secondary ID: National Cancer
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 1995
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervix Neoplasms
• Hypoxia
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Pre-treatment tumour oxygen measurements (under anesthesia)

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Cancer Trials Group, Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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