NCT04312737 - Evaluation of in Vitro Devices on Self-collected Vaginal Swab and Urine Sample for Testing of Human Papilloma Virus | Biotech Hunter

Enrollment

600

Participants

Timeline

Start Date

July 16, 2020

Primary Completion Date

February 23, 2022

Study Completion Date

March 15, 2022

Conditions

Cervical Intraepithelial Neoplasia Grade 2/3Neoplasm CervixCarcinoma in SituCarcinoma Cervix UterineNeoplasmsNeoplasms by Histologic Type

Interventions

DEVICE

Self-Collecting Devices

FLOQSwab (Copan) Colli-Pee (Novosanis)

DIAGNOSTIC_TEST

In Vitro Diagnostic Assays

Papilloplex (GeneFirst) HPV Oncopredict DNA (Hiantis) HPV Oncopredict RNA (GeneFirst)

Trial Locations (6)

The Coombe Women and Infants University Hospital, & Trinity College, Dublin

Dipartimento di Chirurgia e Medicina - Università Milano-Bicocca, Monza

Spedali Civili di Brescia, Brescia

European Institute of Oncology, Milan

ATS-Sardegna Azienda Tutela Salute. ASSL Sassari, Sassari

Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, Edinburgh