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HPV in Blood Samples From Cervical Cancer Patients.

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: NCT03749720
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
By means of digital droplet PCR (ddPCR), this study examines blood samples from patients newly diagnosed with cervical cancer to investigate whether it is possible to measure the presence and amount of HPV DNA in these blood samples. The first blood sample is taken at time of diagnosis, and follow-up blood samples are collected during treatment- and follow-up visits. We expect to find a correlation between the disease stage and the viral load and also a decline in viral load after treatment. Furthermore, we hope that this method may serve as a way of detecting disease recurrence earlier than what is possible today.

Condition or disease Intervention/treatment Phase
HPV-Related Carcinoma HPV-Related Malignancy Other: Blood sample Not Applicable

Detailed Description:
This study hypothesises that in patients with HPV-related cervical cancer, HPV DNA may be released into the bloodstream from tumor cells. These fragments of HPV DNA shed by tumor may therefore be measured in blood samples from the patients. By using the same setting as for real-time PCR with PCR primers and probes for fluorescence detection, the study uses digital droplet PCR (ddPCR), a method based on dilution and partitioning of the blood sample in many reaction chambers or droplets, to measure absolute quantities of HPV DNA fragments in blood samples from women with different stages of cervical cancer. Patients are recruited at the time of diagnosis, where a baseline blood sample is collected. Follow-up blood samples are collected during treatment and at follow-up visits up to two years after the diagnosis. We expect the HPV DNA load to decrease after treatment, and if an increase in viral load is detected during follow-up, we expect this to be an early sign of a disease recurrence. The method may therefore become an effective monitoring tool in these patients in terms of detecting a ongoing disease recurrence, which gives us the chance to intervene and treat these patients before the disease becomes too disseminated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Case-control study with up to 200 case patients newly diagnosed cervical cancer and a control group of 10 healthy women with no prior cervical dysplasia and 10 women with cervical dysplasia (CIN3), respectively.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Can Digital Droplet PCR (ddPCR) on Blood Samples From Patients With HPV Related Cancers Become a Reality in Cancer Treatment and Monitoring?
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Cervical cancer patients
Baseline- and follow-up blood samples are collected from the cervical cancer patients at time of diagnosis and during treatment and clinical follow-up. HPV DNA is measured in these samples.
Other: Blood sample
Blood sample taken from cervical cancer patients at time of diagnosis (baseline) and follow-up visits.




Primary Outcome Measures :
  1. HPV DNA [ Time Frame: Two years ]
    A qualitative and quantitative measure of HPV DNA in blood samples.



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 cases:

  • Diagnosed with cervical cancer ≥ stage 1B between june 2018 and june 2020
  • > 18 years of age at the time of diagnosis
  • There must be available cervical tissue material from the patient to analyse for HPV

Inclusion Criteria healthy controls

  • Women > 18 years with no prior history of any cervical dysplasia

Inclusion Criteria CIN3 controls

  • Women > 18 years
  • Must have a histologically verified severe cervical dysplasia (CIN3)
  • Is admitted for cervical conisation

Exclusion Criteria cases:

  • < 18 years of age at time of cervical cancer diagnosis
  • Cervical cancer < stage 1B

Exclusion Criteria healthy controls:

  • < 18 years of age
  • Prior cervical dysplasia

Exclusion Criteria CIN3 controls:

  • < 18 years of age
  • Women with only low grades of cervical dysplasia (CIN1 or CIN2)
  • Women with HPV-negative cervical biopsies

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): NCT03749720


Contacts
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Contact: Sara Bønløkke Simonsen 0045 53372162 sarasim@clin.au.dk

Locations
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Denmark
Department of Obstetrics and Gynecology Recruiting
Aarhus, Denmark, 8200
Contact: Sara Bønløkke Simonsen    0045 53372162    sarasim@clin.au.dk   
Department of Obstetrics and Gynecolgy Not yet recruiting
Odense, Denmark, 5000
Contact: sara Bønløkke Simonsen    004553372162    sarasim@clin.au.dk   
Sponsors and Collaborators
University of Aarhus
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03749720    
Other Study ID Numbers: U416
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
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 of Aarhus:
Cervical Cancer
HPV
Pathology
ddPCR
Additional relevant MeSH terms:
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Neoplasms