Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-08 @ 7:08 AM
Study NCT ID:
NCT05606133
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2022-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-08-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2022-08-10', 'studyFirstSubmitQcDate': '2022-10-31', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-Treatment Circulating HPV DNA', 'timeFrame': 'Week 0', 'description': 'The presence or absence of ct-HPV DNA'}, {'measure': 'On-Treatment Circulating HPV DNA', 'timeFrame': 'Up to 8 weeks', 'description': 'The presence or absence of ct-HPV DNA'}, {'measure': 'Post-Treatment Circulating HPV DNA', 'timeFrame': '8-12 weeks', 'description': 'The presence or absence of ct-HPV DNA'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Dysplasia', 'Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '26717006', 'type': 'BACKGROUND', '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.'}, {'pmid': '27462593', 'type': 'BACKGROUND', '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.'}, {'pmid': '31088830', 'type': 'BACKGROUND', '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.'}, {'pmid': '28899967', 'type': 'BACKGROUND', '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.'}, {'pmid': '27917295', 'type': 'BACKGROUND', '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.'}, {'pmid': '32017652', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients above age 18, with biopsy proven HPV-related high-grade cervical dysplasia or invasive cervical cancer will be included.\n\nExclusion Criteria:\n\nPersons who do not meet the above inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT05606133', 'briefTitle': 'Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Implementation of Circulating HPV DNA for the Screening and Surveillance of HPV-related Gynecologic Cancers', 'orgStudyIdInfo': {'id': '22-0247'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Circulating HPV DNA', 'interventionNames': ['Diagnostic Test: NavDx(R)']}], 'interventions': [{'name': 'NavDx(R)', 'type': 'DIAGNOSTIC_TEST', '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.', 'armGroupLabels': ['Circulating HPV DNA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10075', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elena Pereira, MD', 'role': 'CONTACT', 'email': 'epereira2@northwell.edu', 'phone': '2124343770'}, {'name': 'Jeannine Villella, MD', 'role': 'CONTACT', 'email': 'jvillella@northwell.edu', 'phone': '2124343770'}], 'facility': 'Lenox Hill Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Elena Pereira, MD', 'role': 'CONTACT', 'email': 'epereira2@northwell.edu', 'phone': '2124343770'}, {'name': 'Jeannine Villella, MD', 'role': 'CONTACT', 'email': 'jvillella@northwell.edu', 'phone': '2124343770'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Naveris', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Elena Pereira', 'investigatorAffiliation': 'Northwell Health'}}}}