FDG-PET and Circulating HPV in Patients With Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT02388698|
Recruitment Status : Active, not recruiting
First Posted : March 17, 2015
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Procedure: Cervical swab Radiation: PET-CT Biological: Plasma HPV||Not Applicable|
The addition of concurrent chemotherapy to definitive radiation has improved the 5-year survival of women with locally advanced cervical cancer to 58%, there is much room for improvement. Post-therapy FDG-PET at 3 months can help predict progression-free and overall survival. Tumors continually shed their DNA into the circulation, where it can be accessed to measure disease burden. Cervical cancer is caused by Human Papilloma Virus (HPV); plasma HPV DNA could be used to monitor response and detect recurrence early. While plasma HPV DNA has been shown to correlate with prognosis and predict recurrence in other cancers, there is limited data in locally advanced cervical cancer.
This prospective multi-institutional study will recruit 20 patients with locally advanced cervical cancer to determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy response on post-therapy FDG-PET scan at 3 months. Patients will undergo phlebotomy at the following time-points for the measurement of circulating HPV DNA levels: a) baseline; b) end of radiotherapy;c) 3 months post completion of chemoradiation, along with 3-month FDG-PET and d) at recurrence. This study will provide preliminary estimates of the correlation between plasma HPV DNA level, PET finding and clinical outcome, and inform sample size calculation for a larger study. If proven useful in the future, plasma HPV DNA could enable the identification of patients at high risk of recurrence and individualized treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||FDG-PET and Circulating HPV in Patients With Cervical Cancer Treated With Definitive Chemoradiation|
|Actual Study Start Date :||November 23, 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: Cervical Swab, PET-CT and plasma HPV
Participants will have a cervical swab, and plasma HPV at baseline. In addition, a plasma HPV test drawn after completion of radiation. 3 months post chemoradiation, patients will have a PET-CT and plasma HPV completed. Plasma HPV will be drawn at progression/recurrence, if applicable.
Procedure: Cervical swab
Cervical Swab at baseline.
HPV testing at recurrence, if applicable.
PET-CT will be completed 3 month post chemoradiation.
Biological: Plasma HPV
Plasma HPV will be drawn at baseline, post radiation, 3 month post chemoradiation and at progression (if necessary).
- Change from baseline in plasma HPV DNA to 3 months. [ Time Frame: Pre treatment and within the first 3 months post treatment ]To determine if HPV DNA predates clinical recurrence and/or improves the accuracy of metabolic response on FDG-PET scan at 3 months post completion of radical chemoradiation in patients with locally advanced cervical cancer
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): NCT02388698
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G2M9|
|Principal Investigator:||Eric Leung, MD||Sunnybrook Research Institute|