Predictive Assays In Cervix Cancer

• 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. ] [ Designated as safety issue: No ]
• 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. ] [ Designated as safety issue: No ]
• 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. ] [ Designated as safety issue: No ]

• To determine if tissue biomarkers of hypoxia such as CA-IX, GLUT-1, HIF-1alpha or others 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. ] [ Designated as safety issue: No ]
• To determine if plasma biomarkers of hypoxia such as osteopontin, and VEGF or others 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. ] [ Designated as safety issue: No ]
• 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. ] [ Designated as safety issue: No ]

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.

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:

-