Cervix:Hypoxia, Interstitial Fluid Pressure and GSH Levels

University Health Network, Toronto

Status and phase: Active, not recruiting; Phase 2

Conditions: Cervix Neoplasms

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

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT00188539

UHN REB 01-0376-C

National Cancer Inst of Canada

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Pre-treatment tumour oxygen measurements (under anesthesia)

Experimental group

Treatment:

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