Predictive Assays In Cervix Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and Tissue and Plasma Biomarkers of Hypoxia (CXTF10)

Conditions
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Cervical Cancer

Intervention / Treatment
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* Other: Tumour Biopsies and Blood Sampling


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assays on cervical cancer tissue<br> | Other: Tumour Biopsies and Blood Sampling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, assay, hypoxia