Predictive Assays In Cervix Cancer
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ClinicalTrials.gov Identifier: NCT01181375 |
Recruitment Status :
Active, not recruiting
First Posted : August 13, 2010
Last Update Posted : November 27, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Cancer | Other: Tumour Biopsies and Blood Sampling | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 500 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and Tissue and Plasma Biomarkers of Hypoxia (CXTF10) |
Actual Study Start Date : | August 1, 2006 |
Estimated Primary Completion Date : | August 2020 |
Estimated Study Completion Date : | August 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Assays on cervical cancer tissue |
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. |
- 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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:
-

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181375
Canada, Ontario | |
University Health Network, Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 |
Principal Investigator: | Anthony Fyles, MD | University Health Network, Princess Margaret Hospital | |
Principal Investigator: | Michael Milosevic, MD | University Health Network, Princess Margaret Hospital |
Responsible Party: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT01181375 |
Other Study ID Numbers: |
UHN REB 06-0379-CE |
First Posted: | August 13, 2010 Key Record Dates |
Last Update Posted: | November 27, 2019 |
Last Verified: | November 2019 |
cervical cancer assay hypoxia |
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |