NCT01181375

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Aug 2006Aug 2027

Study Start

First participant enrolled

August 1, 2006

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2010

Completed
17 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

21 years

First QC Date

August 12, 2010

Last Update Submit

March 3, 2026

Conditions

Cervical Cancer

Keywords

cervical cancerassayhypoxia

Outcome Measures

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.

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

Secondary Outcomes (3)

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

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

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

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

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

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

Study Arms (1)

Assays on cervical cancer tissue

EXPERIMENTAL
Other: Tumour Biopsies and Blood Sampling

Interventions

Tumour Biopsies and Blood SamplingOTHER

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.

Assays on cervical cancer tissue

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsHypoxia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Michael Milosevic, MD

    University Health Network, Princess Margaret Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2010

First Posted

August 13, 2010

Study Start

August 1, 2006

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

CA(1)