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

Primary Purpose

Cervical Dysplasia, Cervical Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NavDx(R)
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Dysplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: All patients above age 18, with biopsy proven HPV-related high-grade cervical dysplasia or invasive cervical cancer will be included. Exclusion Criteria: Persons who do not meet the above inclusion criteria.

Sites / Locations

  • Lenox Hill HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Circulating HPV DNA

Arm Description

Outcomes

Primary Outcome Measures

Pre-Treatment Circulating HPV DNA
The presence or absence of ct-HPV DNA
On-Treatment Circulating HPV DNA
The presence or absence of ct-HPV DNA
Post-Treatment Circulating HPV DNA
The presence or absence of ct-HPV DNA

Secondary Outcome Measures

Full Information

First Posted
August 10, 2022
Last Updated
October 31, 2022
Sponsor
Northwell Health
Collaborators
Naveris
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1. Study Identification

Unique Protocol Identification Number
NCT05606133
Brief Title
Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers
Official Title
Implementation of Circulating HPV DNA for the Screening and Surveillance of HPV-related Gynecologic Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
August 10, 2024 (Anticipated)
Study Completion Date
August 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
Naveris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dysplasia, Cervical Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Circulating HPV DNA
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
NavDx(R)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pre-Treatment Circulating HPV DNA
Description
The presence or absence of ct-HPV DNA
Time Frame
Week 0
Title
On-Treatment Circulating HPV DNA
Description
The presence or absence of ct-HPV DNA
Time Frame
Up to 8 weeks
Title
Post-Treatment Circulating HPV DNA
Description
The presence or absence of ct-HPV DNA
Time Frame
8-12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. Exclusion Criteria: Persons who do not meet the above inclusion criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Pereira, MD
Phone
2124343770
Email
epereira2@northwell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeannine Villella, MD
Phone
2124343770
Email
jvillella@northwell.edu
Facility Information:
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Pereira, MD
Phone
212-434-3770
Email
epereira2@northwell.edu
First Name & Middle Initial & Last Name & Degree
Jeannine Villella, MD
Phone
2124343770
Email
jvillella@northwell.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26717006
Citation
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.
Results Reference
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PubMed Identifier
27462593
Citation
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.
Results Reference
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PubMed Identifier
31088830
Citation
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.
Results Reference
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PubMed Identifier
28899967
Citation
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.
Results Reference
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PubMed Identifier
27917295
Citation
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.
Results Reference
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PubMed Identifier
32017652
Citation
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. Erratum In: J Clin Oncol. 2020 Oct 20;38(30):3579. J Clin Oncol. 2023 Sep 20;41(27):4449.
Results Reference
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Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers

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