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NCT Number: NCT00188539

Cervix: Hypoxia, Interstitial Fluid Pressure and GSH Levels

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cervix Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre-treatment tumour oxygen measurements (under anesthesia)

Procedure

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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Canadian Cancer Trials Group
  • Princess Margaret Hospital, Canada

Registry information

Official study title

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

Important dates

Study start
1995
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2005
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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