Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598176
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Developing a Combined Molecular Screening and Triage Test for Cervical Cancer Based on Human Papillomavirus HPV Detection Quantification Genotyping and DNA Methylation in Self-samples COMBISCREEN
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMBISCREEN
Brief Summary:
The goal of the COMBISCREEN project is to develop a fully molecular cervical screening and triage approach that is applicable on self-samples which are an easily accessible and non-invasive source of biomarkers The project allows a one-step screening and triage modality and thereby identifies women with clinically relevant disease that are in need of treatment
Detailed Description:
Currently there is still 37 of the Flemish population eligible for cervical cancer screening that remains underscreened Self-collected urine and vaginal samples that can be collected from home and are non-invasive provide an attractive alternative for this group The aim of this study is to collect different samples from patients with a cervical cancer or a scheduled conization in order to identify potential biomarkers for cervical cancer and cervical intraepithelial neoplasia CIN These samples include a home-collected first-void urine Colli-Pee 20mL prefilled with urine conservation medium UCM and vaginal self-sample Evalyn Brush as well as a clinician collected cervical smear blood sample and when appropriate also a tissue sample A tissue sample will only be collected when the patient is undergoing surgical procedures for their standard therapy As such they do not undergo additional invasive procedures as part of the study The samples are collected prior to starting therapeutic processes eg conization chemotherapy radiotherapy surgery The presence of biomarkers eg human papillomavirus HPV and DNA methylation for cervical cancer and cervical intraepithelial neoplasia CIN will be determined and compared in each of the sample types The results of the biomarker assays will also be compared to clinical results from cytology and histology in order to determine the accuracy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None