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Active, not recruitingNCT00188539Updated Mar 6, 2026

Cervix: Hypoxia, Interstitial Fluid Pressure and GSH Levels

A Phase 2 interventional study of Pre-treatment tumour oxygen measurements (under anesthesia) in Cervix Neoplasms, sponsored by University Health Network, Toronto. Active, not recruiting at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
346
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Cervix Neoplasms
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 346 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with clinically occult cervix carcinoma
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Enrollment
346 participants (actual)

Study arms

  • Experimental
    Pre-treatment tumour oxygen measurements (under anesthesia)

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

Interventions

  • ProcedurePre-treatment tumour oxygen measurements (under anesthesia)
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What researchers measure

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

07

Study locations

1 site
  • Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00188539
Lead sponsor
University Health Network, Toronto
Collaborators
Canadian Cancer Trials Group, Princess Margaret Hospital, Canada
Responsible party
Sponsor
First posted
Sep 16, 2005
Start date
Dec 1995
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Mar 6, 2026

Study contacts

Michael F Milosevic
principal investigator · Princess Margaret Hospital, Canada

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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