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Trial record 32 of 12460 for:    cervical

FDG-PET and Circulating HPV in Patients With Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02388698
Recruitment Status : Active, not recruiting
First Posted : March 17, 2015
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
Dr. Eric Leung, Sunnybrook Health Sciences Centre

Brief 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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Procedure: Cervical swab Radiation: PET-CT Biological: Plasma HPV Not Applicable

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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).




Primary Outcome Measures :
  1. 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



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

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

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G2M9
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Princess Margaret Hospital, Canada
Investigators
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Principal Investigator: Eric Leung, MD Sunnybrook Research Institute

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Responsible Party: Dr. Eric Leung, Radiation Oncologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02388698     History of Changes
Other Study ID Numbers: HPVDNA01
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

Keywords provided by Dr. Eric Leung, Sunnybrook Health Sciences Centre:
HPV DNA
PET-CT
Recurrent cervical cancer
chemoradiation

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female