Predictive Assays In Cervix Cancer
This study is currently recruiting participants.
Verified December 2012 by University Health Network, Toronto
Sponsor:
University Health Network, Toronto
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01181375
First received: August 12, 2010
Last updated: December 17, 2012
Last verified: December 2012
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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 2013 |
| Estimated Primary Completion Date: | August 2013 (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:
- 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
Exclusion Criteria:
-
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181375
Contacts
| Contact: Anthony Fyles, MD | 416 946 4501 ext 6522 | anthony.fyles@rmp.uhn.on.ca |
| Contact: Michael Milosevic, MD | 416 946 4501 ext 6522 | michael.milosevic@rmp.uhn.on.ca |
Locations
| Canada, Ontario | |
| University Health Network, Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Anthony Fyles, MD 416 946 4501 ext 6522 anthony.fyles@rmp.uhn.on.ca | |
| Contact: Michael Milosevic, MD 416 946 4501 ext 6522 michael.milosevic@rmp.on.ca | |
| Principal Investigator: Michael Milosevic, MD | |
| Principal Investigator: Anthony Fyles, MD | |
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: | December 17, 2012 |
| 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 June 18, 2013