HPV-Related Carcinoma Clinical Trial
Official title:
Can Digital Droplet PCR (ddPCR) on Blood Samples From Patients With HPV Related Cancers Become a Reality in Cancer Treatment and Monitoring?
NCT number | NCT03749720 |
Other study ID # | U416 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 15, 2018 |
Est. completion date | October 30, 2022 |
Verified date | September 2021 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 141 |
Est. completion date | October 30, 2022 |
Est. primary completion date | October 30, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Obstetrics and Gynecology | Aarhus | |
Denmark | Department of Obstetrics and Gynecolgy | Odense |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HPV DNA | A qualitative and quantitative measure of HPV DNA in blood samples. | Two years |
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