Criteria for eligibility:
Study pop:
Women with abnormal smear (HPV-genotype and cytology) referred to colposcopy, visibel
transformation zone (type 1 or 2) and where cervical biopsies has been sent to pathology
examination.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Women referred to colposcopy due to abnormal smear (HPV-genotype and cytology) in
Central Denmark Region or Southern Denmark Region.
Exclusion Criteria:
- Allergic to iodine.
- Tranformationzone not visible (type 3).
- Atrophy of cervical epithelium.
- Women referred to colposcopy with no cervical biopsies taken or invalid cervical
biopsies.
- Women with previous cone biopsy, hysterectomy or without a cervix due to cervical
cancer will be excluded.
- Pregnant women.
Gender:
Female
Gender based:
Yes
Gender description:
This study is focused on cervical cancer and precancer. Since only women have a cervix,
only women will be included in this study.
Minimum age:
23 Years
Maximum age:
99 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Guldberg Kvindeklinik
Address:
City:
Fredericia
Zip:
7000
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Rikke Guldberg
Phone:
+4575806480
Email:
rguldberg@dadlnet.dk
Facility:
Name:
Gødstrup Regional Hospital
Address:
City:
Herning
Zip:
7400
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Anne Hammer
Phone:
+23494736
Email:
ahlauridsen@clin.au.dk
Facility:
Name:
Horsens Gynækologisk Klinik
Address:
City:
Horsens
Zip:
8700
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Helene Nortvig
Phone:
+4575614808
Email:
nortvig@dadlnet.dk
Facility:
Name:
Horsens Regional Hospital
Address:
City:
Horsens
Zip:
8700
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Christina Blach
Phone:
+457842 6444
Email:
chissore@rm.dk
Facility:
Name:
Odense Univeristy Hospital
Address:
City:
Odense
Zip:
5000
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Lone Kjeld Petersen
Phone:
+4530576810
Email:
Lone.Kjeld.Petersen@rsyd.dk
Facility:
Name:
Randers Regional Hospital
Address:
City:
Randers
Zip:
8900
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Eva Hauge
Phone:
+4578421114
Email:
evahauge@rm.dk
Facility:
Name:
Viborg Regional Hospital
Address:
City:
Viborg
Zip:
8800
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Attila Botházi
Phone:
+45 78445865
Email:
attiboth@rm.dk
Start date:
March 1, 2023
Completion date:
July 1, 2025
Lead sponsor:
Agency:
University of Aarhus
Agency class:
Other
Source:
University of Aarhus
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05870787
