Predictive Assays In Cervix Cancer

Not Applicable

Active, not recruiting

• Conditions: Cervical Cancer
• Interventions: Other: Tumour Biopsies and Blood Sampling

• Registration Number: NCT01181375
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-01
• Study First Submitted: 2010-08-12
• Study First Submitted QC: 2010-08-12
• Study First Posted: 2010-08-13
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 500

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assays on cervical cancer tissue	Tumour Biopsies and Blood Sampling	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

University Health Network, Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada