CASUS: Validation for Detection of Precursor Lesions

Plain-language summary

This study aims to validate a urine collection device called Colli-Pee for detecting precursor lesions of cervical cancer. It enrolled women aged 25 to 64 referred for colposcopy due to a high-risk HPV infection and/or an abnormal cervical lesion. This is a study without an assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Universiteit Antwerpen

Intervention

Colli-Pee Small Volumes (10 mL) device

Start date

8/20/2020

Estimated completion

2/28/2022

Countries

Belgium

Related genes

Locations

• Ghent, Belgium
• Tienen, Belgium
• Liège, Belgium

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Female
* 25 years until 64 years old
* Referred to colposcopy due to a single/multiple (probable) high-risk HPV infection and/or abnormal cervical squamous intraepithelial/glandular lesion.
* Gives informed consent to the research team at the clinical study site to contact his/her general practitioner and/or gynaecologist to access details of the participants HPV test results and cervical screening history.
* Is able to understand the information brochure/what the study is about.

Exclusion Criteria:

* Women that underwent hysterectomy
* Pregnant women
* Treatment for cervical cancer in the last 6 months before participation in the study
* Participating in an interventional clinical study (where e.g. a medical device, drug, or vaccine is evaluated) at the same time of participating in this study. Participation in another observational or low-interventional clinical study at the same time is allowed.