Cervix: Hypoxia, Interstitial Fluid Pressure and GSH Levels

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00188539

Enrollment

346

Registered

2005-09-16

Start date

1995-12-01

Completion date

2027-12-01

Last updated

2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervix Neoplasms

Brief 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.

Interventions

PROCEDUREPre-treatment tumour oxygen measurements (under anesthesia)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

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.	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.	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

Measure	Time frame
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

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORMichael F Milosevic

Princess Margaret Hospital, Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026