Predictive Assays In Cervix Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01181375
First received: August 12, 2010
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Cervical Cancer
Other: Tumour Biopsies and Blood Sampling

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and Tissue and Plasma Biomarkers of Hypoxia (CXTF10)

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: August 2006
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Assays on cervical cancer tissue Other: Tumour 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01181375

Locations
Canada, Ontario
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Anthony Fyles, MD University Health Network, Princess Margaret Hospital
Principal Investigator: Michael Milosevic, MD University Health Network, Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01181375     History of Changes
Other Study ID Numbers: UHN REB 06-0379-CE
Study First Received: August 12, 2010
Last Updated: June 24, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
cervical cancer
assay
hypoxia

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 31, 2014