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FDG-PET and Circulating HPV in Patients With Cervical Cancer Treated With Definitive Chemoradiation (II) (HPVDNA02)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03853915
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : April 6, 2023
Sponsor:
Collaborator:
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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Brief Summary:

Nearly all cervical cancers are caused by the human papilloma virus (HPV), which can be detected in cancer tissue by laboratory tests. There is evidence that the virus can also be detected from a blood sample to monitor the effects of treatment. Previous studies have shown that a special test called 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET-CT) at 3 months after treatment may predict survival in cervical cancer.

The purpose of this study is to see how well the FDG-PET Scan and blood tests for HPV can detect leftover cervical cancer cells after treatment. This study is not a particular form of treatment and patients will receive standard of care treatment.


Condition or disease Intervention/treatment Phase
Cervical Cancer Diagnostic Test: [18-F]- FDG - PET Not Applicable

Detailed Description:

Cervical cancer is the 4th most common malignancy in women worldwide. A significant proportion of women with locally advanced cervical cancer are primarily managed with chemotherapy and radiotherapy which has improved the 5-year survival and disease-free survival; however both local and distant recurrences still remain to be challenges after treatment.

A prospective study has shown that metabolic response on post-therapy FDG-PET scan at 3 months to be predictive of progression-free and overall survival in patients with locally advanced cervical cancer. It may also predict patterns of failures for these patients.

HPV is recognized as a necessary cause of the vast majority of cervical cancer and HPV DNA has been detected in circulation from patients with cervical cancer and oropharyngeal cancer at diagnosis and at the time of relapse. Despite the promising potential of HPV DNA to monitor response and detect recurrence at an early stage, no study has evaluated serial HPV DNA and its association with PET response and survival.

We have recently reported preliminary data from a feasibility study (HPVDNA01) on 20 patients. Detectable HPV DNA at the end of cervical radiation therapy predated the clinical diagnosis of metastases and was associated with inferior progression-free survival. Also, 3 month plasma HPV DNA level was more accurate than 3-month FDG PET imaging in detecting leftover disease. This follow-up study aims to validate the clinical utility of plasma HPV DNA detection.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Newly diagnosed FIGO stage IB-IVA cervical cancer patients planned for definitive chemoradiation will be accrued to study and will have:

  1. FDG PET Scan at 3 month time point.
  2. Blood sample to measure HPV DNA at time point baseline, end of radiotherapy, 4-6 weeks and 3 months post completion of definitive radiotherapy.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: FDG-PET and Circulating HPV in Patients With Cervical Cancer Treated With Definitive Chemoradiation (II)
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : December 30, 2025
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: FDG PET Scan
[F-18] - FDG PET Scan and blood sample to measure HPV DNA
 Diagnostic Test: [18-F]- FDG - PET
[F-18]-FDG Injection is an intravenous diagnostic radiopharmaceutical used for Positron Emission Tomography. While this is not the subject of investigation in this study, [F-18]-FDG will be used in the PET imaging assessment of study participants during their 3 month follow-up post-treatment.


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival rate [ Time Frame: up to 5 years ]
    The progression-free survival rate of patients with and without detectable plasma HPV DNA post treatment


Secondary Outcome Measures :
  1. Plasma HPV DNA levels [ Time Frame: Up to 3 months ]
    The accuracy of 3-month FDG-PET or 3-month HPV DNA for predicting relapse will be estimated.


Eligibility Criteria
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Information from the National Library of Medicine

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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
  • 3.1.2 Planned for radical radiotherapy and concurrent cisplatin chemotherapy.
  • 3.1.3 Age ≥ 18 years.

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.
  • Other cervical cancer tumor histologies (e.g. small cell, serous)
  • Contraindications to 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
Contacts and Locations
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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): NCT03853915


Contacts
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Contact: Kathy Han, MD 416 946 4501 ext 2919 kathy.han@rmp.uhn.ca

Locations
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Canada, Ontario
University Health Network, The Princess Margaret Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Kathy Han, MD    416 946 4501 ext 2919    Kathy.Han@rmp.uhn.on.ca   
Contact: Michael Milosevic, MD    416 946 4501 ext 2932    Mike.Milosevic@rmp.uhn.on.ca   
Sponsors and Collaborators
University Health Network, Toronto
Sunnybrook Health Sciences Centre
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03853915    
Other Study ID Numbers: 18-6277
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: April 6, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Cervical Cancer
PET Scan
HPV DNA
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
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases