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Predictive Assays In Cervix Cancer

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ClinicalTrials.gov Identifier: NCT01181375
Recruitment Status : Active, not recruiting
First Posted : August 13, 2010
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Other: Tumour Biopsies and Blood Sampling Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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)
Actual Study Start Date : August 1, 2006
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181375


Locations
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Canada, Ontario
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Anthony Fyles, MD University Health Network, Princess Margaret Hospital
Principal Investigator: Michael Milosevic, MD University Health Network, Princess Margaret Hospital
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01181375    
Other Study ID Numbers: UHN REB 06-0379-CE
First Posted: August 13, 2010    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Keywords provided by University Health Network, Toronto:
cervical cancer
assay
hypoxia
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female