FDG-PET and Circulating HPV in Patients With Cervical Cancer

NCT02388698 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-09-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Princess Margaret Hospital, Canada

    collaborator OTHER
  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Eric Leung, MD · Sunnybrook Research Institute

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-23
Primary Completion
2019-12-31
Completion
2023-12-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02388698 on ClinicalTrials.gov