NCT05606133

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Aug 2022Aug 2026

First Submitted

Initial submission to the registry

August 10, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

August 10, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2026

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

4 years

First QC Date

August 10, 2022

Last Update Submit

September 18, 2025

Conditions

Cervical DysplasiaCervical Cancer

Outcome Measures

Primary Outcomes (3)

  • Pre-Treatment Circulating HPV DNA

    The presence or absence of ct-HPV DNA

    Week 0

  • On-Treatment Circulating HPV DNA

    The presence or absence of ct-HPV DNA

    Up to 8 weeks

  • Post-Treatment Circulating HPV DNA

    The presence or absence of ct-HPV DNA

    8-12 weeks

Study Arms (1)

Circulating HPV DNA

EXPERIMENTAL
Diagnostic Test: NavDx(R)

Interventions

NavDx(R)DIAGNOSTIC_TEST

NavDx® is a blood test that utilizes digital droplet PCR in order to quantify fragments of tumor-specific DNA shed by HPV-associated cancer cells in the blood. The technology has the ability to distinguish tumor-tissue modified virus particles present in the plasma cell-free DNA from non-cancer associated sources of HPV DNA.

Circulating HPV DNA

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients above age 18, with biopsy proven HPV-related high-grade cervical dysplasia or invasive cervical cancer will be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

Related Publications (6)

  • Pereira E, Camacho-Vanegas O, Anand S, Sebra R, Catalina Camacho S, Garnar-Wortzel L, Nair N, Moshier E, Wooten M, Uzilov A, Chen R, Prasad-Hayes M, Zakashansky K, Beddoe AM, Schadt E, Dottino P, Martignetti JA. Personalized Circulating Tumor DNA Biomarkers Dynamically Predict Treatment Response and Survival In Gynecologic Cancers. PLoS One. 2015 Dec 30;10(12):e0145754. doi: 10.1371/journal.pone.0145754. eCollection 2015.

    PMID: 26717006BACKGROUND

  • Oh J, Lee HJ, Lee TS, Kim JH, Koh SB, Choi YS. Clinical value of routine serum squamous cell carcinoma antigen in follow-up of patients with locally advanced cervical cancer treated with radiation or chemoradiation. Obstet Gynecol Sci. 2016 Jul;59(4):269-78. doi: 10.5468/ogs.2016.59.4.269. Epub 2016 Jul 13.

    PMID: 27462593BACKGROUND

  • Chera BS, Kumar S, Beaty BT, Marron D, Jefferys S, Green R, Goldman EC, Amdur R, Sheets N, Dagan R, Hayes DN, Weiss J, Grilley-Olson JE, Zanation A, Hackman T, Blumberg JM, Patel S, Weissler M, Tan XM, Parker JS, Mendenhall W, Gupta GP. Rapid Clearance Profile of Plasma Circulating Tumor HPV Type 16 DNA during Chemoradiotherapy Correlates with Disease Control in HPV-Associated Oropharyngeal Cancer. Clin Cancer Res. 2019 Aug 1;25(15):4682-4690. doi: 10.1158/1078-0432.CCR-19-0211. Epub 2019 May 14.

    PMID: 31088830BACKGROUND

  • Kang Z, Stevanovic S, Hinrichs CS, Cao L. Circulating Cell-free DNA for Metastatic Cervical Cancer Detection, Genotyping, and Monitoring. Clin Cancer Res. 2017 Nov 15;23(22):6856-6862. doi: 10.1158/1078-0432.CCR-17-1553. Epub 2017 Sep 12.

    PMID: 28899967BACKGROUND

  • Jeannot E, Becette V, Campitelli M, Calmejane MA, Lappartient E, Ruff E, Saada S, Holmes A, Bellet D, Sastre-Garau X. Circulating human papillomavirus DNA detected using droplet digital PCR in the serum of patients diagnosed with early stage human papillomavirus-associated invasive carcinoma. J Pathol Clin Res. 2016 Jun 28;2(4):201-209. doi: 10.1002/cjp2.47. eCollection 2016 Oct.

    PMID: 27917295BACKGROUND

  • Chera BS, Kumar S, Shen C, Amdur R, Dagan R, Green R, Goldman E, Weiss J, Grilley-Olson J, Patel S, Zanation A, Hackman T, Blumberg J, Patel S, Thorp B, Weissler M, Yarbrough W, Sheets N, Mendenhall W, Tan XM, Gupta GP. Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in HPV-Associated Oropharyngeal Cancer. J Clin Oncol. 2020 Apr 1;38(10):1050-1058. doi: 10.1200/JCO.19.02444. Epub 2020 Feb 4.

    PMID: 32017652BACKGROUND

MeSH Terms

Conditions

Uterine Cervical DysplasiaUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by Site

Central Study Contacts

Elena Pereira, MD

CONTACT

2124343770epereira2@northwell.edu

Jeannine Villella, MD

CONTACT

2124343770jvillella@northwell.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 10, 2022

First Posted

November 4, 2022

Study Start

August 10, 2022

Primary Completion (Estimated)

August 10, 2026

Study Completion (Estimated)

August 10, 2026

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)