Predictive Assays In Cervix Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-01

Study Completion Date

2027-08-31

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.

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Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Assays on cervical cancer tissue

Group Type EXPERIMENTAL

Tumour Biopsies and Blood Sampling

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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