FDG-PET and Circulating HPV in Patients With Cervical Cancer

September 20, 2021 updated by: Dr. Eric Leung, Sunnybrook Health Sciences Centre

FDG-PET and Circulating HPV in Patients With Cervical Cancer Treated With Definitive Chemoradiation

The addition of concurrent chemotherapy to definitive radiation has improved the 5-year survival of women with locally advanced cervical cancer to 58%. To determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy of metabolic response on FDG-PET at 3 months post completion of radical chemo-radiation in patients with locally advanced cervical cancer. Post therapy FDG-PET can help predict progression free survival and overall survival. In addition plasma HPV can be used to monitor response and detect early recurrence. Prospective 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G2M9
        • Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, FIGO stage IB-IVA
  • planned for radical radiotherapy and concurrent cisplatin chemotherapy.
  • Age ≥ 18 years.
  • Life expectancy of greater than 3 months.

Exclusion Criteria:

  • Evidence of distant metastases (suspicious paraaortic nodes below the renal vessels allowed if they will be encompassed within the radiation field)
  • Patients who have received any anticancer treatment for their cervical cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance status > 2
  • Other cervical cancer tumor histologies (e.g. small cell, serous)
  • Contraindications to 18FDG PET-CT
  • Inability to lie supine for radiation and/or 18FDG PET-CT
  • Contraindication to radiotherapy (e.g. severe Crohn's disease)
  • Contraindication to chemotherapy (e.g. non-reversible renal failure)
  • History of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for ≥ 5 years.
  • Known pregnancy or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

Radiation: PET-CT
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre treatment and within the first 3 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Princess Margaret Hospital, Canada

Investigators

  • Principal Investigator: Eric Leung, MD, Sunnybrook Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 23, 2016

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (ESTIMATE)

March 17, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPVDNA01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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