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Active, not recruitingNCT01181375Updated Mar 5, 2026

Predictive Assays In Cervix Cancer

An interventional study of Tumour Biopsies and Blood Sampling in Cervical Cancer, 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 2026-03-05.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 4 years after the study started (first participant enrolled Aug 2006, registered Aug 2010).
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
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Study summary

The experiments outlined in this proposal will compare a number of currently available techniques for assessing hypoxia and interstitial fluid pressures in patients with cervix cancer. The aim of these experiments is to establish the relationship of the clinically relevant outcome measures of tumour control and survival following radiation therapy with these biological characteristics of carcinoma of the cervix relevant to tumour hypoxia. These characteristics will be assessed in patients undergoing treatment using techniques which have reached an appropriate level of development for clinical evaluation and aim to determine the best technique for determining these parameters of the tumour microenvironment. A number of novel strategies directed at the microenvironment are undergoing or soon will be undergoing clinical evaluation and selection of appropriate patients for these trials is of great importance.

02

Conditions studied

  • Cervical Cancer

Keywords

  • cervical cancer
  • assay
  • hypoxia
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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 planned enrollment of 500 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.

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Who can participate

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

Inclusion criteria

  1. Histologic diagnosis of cervix cancer
  2. A decision to treat using radiation therapy according to the existing treatment policies of the PMH Gynecology Group
  3. Clinical stage IB-IV with grossly evident cervical disease
  4. No distant metastases
  5. No cytotoxic anti-cancer therapy for cervical carcinoma prior to study entry
  6. Signed informed consent

Exclusion criteria

Exclusion Criteria:

-

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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    Assays on cervical cancer tissue

    Other: Tumour Biopsies and Blood Sampling

Interventions

  • OtherTumour Biopsies and Blood Sampling

    Patients who consent to the tissue part of this study will have Biopsies taken for study purposes at the same time as their routine tumour biopsies . In addition,those who consent to the blood sampling part of the study will have their samples taken assess serum biomarkers of tumour oxygenation.

06

What researchers measure

Primary outcomes

  1. To understand the mechanisms by which hypoxia and IFP influence disease progression, and response to radiotherapy, chemotherapy and other novel biologically-targeted therapies in patients with cervix cancer.

    Time frame: 3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.

Secondary outcomes

  1. To determine if tissue biomarkers of hypoxia are independent prognostic factors for relapse and survival in patients with cervix cancer.

    Time frame: 3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.

  2. To determine if plasma biomarkers of hypoxia are independent prognostic factors for relapse and survival in patients with cervix cancer.

    Time frame: 3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.

  3. To assess the heterogeneity of tissue biomarkers of hypoxia in multiple biopsies from cervix cancers.

    Time frame: 3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.

07

Study locations

1 site
  • University Health Network, Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01181375
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Aug 13, 2010
Start date
Aug 1, 2006
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Mar 5, 2026

Study contacts

Michael Milosevic, MD
principal investigator · University Health Network, Princess Margaret Hospital

Oversight

Data monitoring committee
Yes
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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