Status:
COMPLETED
HPV in Blood Samples From Cervical Cancer Patients.
Lead Sponsor:
University of Aarhus
Conditions:
HPV-Related Carcinoma
HPV-Related Malignancy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
By means of digital droplet PCR (ddPCR) anf targeted Next Generation Sequencing (NGS), this study examines blood samples from patients newly diagnosed with cervical cancer to investigate whether it is...
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 meas...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2022
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT03749720
Start Date
June 15 2018
End Date
October 30 2022
Last Update
April 1 2025
Active Locations (2)
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1
Department of Obstetrics and Gynecology
Aarhus, Denmark, 8200
2
Department of Obstetrics and Gynecolgy
Odense, Denmark, 5000