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Predictive Assays for Cervical Cancer

N/A
Waitlist Available
Led By Anthony Fyles, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No cytotoxic anti-cancer therapy for cervical carcinoma prior to study entry
No distant metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.
Awards & highlights

Study Summary

This trial will compare different techniques for measuring how much oxygen is reaching a patient's cervix cancer and how much pressure is in the tissues around the tumor. The goal is to see which technique is most accurate in determining a patient's chances of survival following radiation therapy.

Who is the study for?
This trial is for individuals with a confirmed diagnosis of cervical cancer, who are set to undergo radiation therapy as per the PMH Gynecology Group's treatment guidelines. It's open to those with clinical stage IB-IV and visible cervical disease but no distant metastases. Participants must not have received prior cytotoxic anti-cancer therapy for their condition and must provide signed informed consent.Check my eligibility
What is being tested?
The study is examining various techniques to measure hypoxia (low oxygen levels) and fluid pressures in cervix tumors, aiming to link these factors with tumor control and survival rates post-radiation therapy. The goal is to identify the best method for assessing these aspects of the tumor environment, which could help select patients for future trials targeting the microenvironment.See study design
What are the potential side effects?
Since this trial involves tumour biopsies and blood sampling rather than drug interventions, side effects may include discomfort or pain at biopsy sites, bleeding, infection risk from procedures, and potential psychological distress from additional testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not received chemotherapy for cervical cancer before joining this study.
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My cancer has not spread to distant parts of my body.
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I have been diagnosed with cervical cancer.
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My cervical cancer is between stages IB and IV and can be seen without a microscope.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
To assess the heterogeneity of tissue biomarkers of hypoxia in multiple biopsies from cervix cancers.
To determine if plasma biomarkers of hypoxia are independent prognostic factors for relapse and survival in patients with cervix cancer.
To determine if tissue biomarkers of hypoxia are independent prognostic factors for relapse and survival in patients with cervix cancer.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Assays on cervical cancer tissueExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,478 Previous Clinical Trials
484,900 Total Patients Enrolled
Anthony Fyles, MDPrincipal InvestigatorUniversity Health Network, Princess Margaret Hospital
7 Previous Clinical Trials
764 Total Patients Enrolled
Michael Milosevic, MDPrincipal InvestigatorUniversity Health Network, Princess Margaret Hospital
10 Previous Clinical Trials
648 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Predictive Assays In Cervix Cancer
2006. "Predictive Assays In Cervix Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01181375.
All > Cervical Cancer
~5 spots leftby Aug 2024
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