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NCT05606133 · ClinicalTrials.gov registry record · NA
Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers
A NA study of Cervical Cancer and Cervical Dysplasia, sponsored by Northwell Health.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05606133 is a NA study of Cervical Cancer and Cervical Dysplasia that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 100 participants, below the 570-participant average among 144 other Cervical Cancer trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05606133, a NA study of Cervical Cancer and Cervical Dysplasia, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Human papilloma virus-related gynecologic malignancies affect over 20,000 women in the United States, and over half a million women globally each year. In addition, approximately 200,000 women are diagnosed with high-grade cervical dysplasia, a pre-cancerous tumor. There is no currently available serum biomarker for these tumors, and surveillance and diagnosis in these patients often requires invasive testing and procedures. The ability to diagnose and monitor for these cancers with a simple blood draw would have a significant impact both here in the US and abroad. In order to detect circulating tumor-specific HPV DNA, the investigators will collaborate with the molecular diagnostics company, Naveris. Naveris has designed a blood test that utilizes digital droplet polymerase chain reactions (PCR) in order to quantify fragments of tumor-specific DNA that the investigators believe is shed by HPV-associated cancer cells in the blood. In this pilot study, the investigators will first test whether the quantification of plasma cell-free HPV DNA can distinguish pre-invasive from invasive cervical cancers.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST NavDx(R)
Study Locations (1)
New York
- Lenox Hill Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-08-10 |
| Est. Completion | 2026-08-10 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05606133
The ClinicalTrials.gov registry entry for NCT05606133 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 570-participant average among 144 other Cervical Cancer trials with a reported enrollment target (82% lower). The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cervical Cancer appearing as the primary indexed condition, and to 1 intervention - of which NavDx(R) is the first listed.
NCT05606133 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05606133 about?
NCT05606133 is a clinical study titled "Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers". Human papilloma virus-related gynecologic malignancies affect over 20,000 women in the United States, and over half a million women globally each year. In addition, approximately 200,000 women are diagnosed with high-grade cervical dysplasia, a pre-cancerous tumor. There is no currently available se...
What is the current status of trial NCT05606133?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2022-08-10. Estimated completion is 2026-08-10.
What conditions does trial NCT05606133 study?
This clinical trial studies the following conditions: Cervical Cancer, Cervical Dysplasia.
What interventions are being tested in trial NCT05606133?
The interventions under investigation include: NavDx(R) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05606133?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05606133 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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