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
|Condition or disease||Intervention/treatment||Phase|
|HPV-Related Carcinoma HPV-Related Malignancy||Other: Blood sample||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|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)|
|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|
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.
- HPV DNA [ Time Frame: Two years ]A qualitative and quantitative measure of HPV DNA in blood samples.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749720
|Contact: Sara Bønløkke Simonsen||0045 firstname.lastname@example.org|
|Department of Obstetrics and Gynecology||Recruiting|
|Aarhus, Denmark, 8200|
|Contact: Sara Bønløkke Simonsen 0045 53372162 email@example.com|
|Department of Obstetrics and Gynecolgy||Not yet recruiting|
|Odense, Denmark, 5000|
|Contact: sara Bønløkke Simonsen 004553372162 firstname.lastname@example.org|