Predictive Assays In Cervix Cancer

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01181375
• Other study ID #: UHN REB 06-0379-CE
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2006
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	University Health Network, Princess Margaret Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.