Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers

NCT ID: NCT05606133

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-10
• Study Completion Date: 2026-08-10

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.

Conditions

Cervical Dysplasia; Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Circulating HPV DNA

Group Type: EXPERIMENTAL

NavDx(R)

Intervention Type: 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.

Interventions

NavDx(R)

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Naveris

UNKNOWN

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Elena Pereira

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lenox Hill Hospital

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elena Pereira, MD

Role: CONTACT

epereira2@northwell.edu

2124343770

Jeannine Villella, MD

Role: CONTACT

jvillella@northwell.edu

2124343770

Facility Contacts

Elena Pereira, MD

Role: primary

epereira2@northwell.edu

2124343770

Jeannine Villella, MD

Role: backup

jvillella@northwell.edu

2124343770

References

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.

Reference Type: BACKGROUND

PMID: 26717006 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27462593 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31088830 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28899967 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27917295 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32017652 (View on PubMed)

Other Identifiers

22-0247

Identifier Type: -

Identifier Source: org_study_id