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Predictive Assays In Cervix Cancer

Primary Purpose

Cervical Cancer

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Tumour Biopsies and Blood Sampling
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cervical Cancer focused on measuring cervical cancer, assay, hypoxia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

-

Sites / Locations

  • University Health Network, Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Assays on cervical cancer tissue

Arm Description

Outcomes

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.

Secondary Outcome Measures

To determine if tissue biomarkers of hypoxia are independent prognostic factors for relapse and survival in patients with cervix cancer.
To determine if plasma biomarkers of hypoxia are independent prognostic factors for relapse and survival in patients with cervix cancer.
To assess the heterogeneity of tissue biomarkers of hypoxia in multiple biopsies from cervix cancers.

Full Information

First Posted
August 12, 2010
Last Updated
October 3, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01181375
Brief Title
Predictive Assays In Cervix Cancer
Official Title
Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and Tissue and Plasma Biomarkers of Hypoxia (CXTF10)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2006 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
cervical cancer, assay, hypoxia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Assays on cervical cancer tissue
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Tumour Biopsies and Blood Sampling
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Fyles, MD
Organizational Affiliation
University Health Network, Princess Margaret Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Milosevic, MD
Organizational Affiliation
University Health Network, Princess Margaret Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network, Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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Predictive Assays In Cervix Cancer

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