Study Summary
This trial will test a simple blood test to detect HPV-related gynecologic cancers and pre-cancerous tumors, which could help diagnose and monitor these conditions more easily.
Eligible Conditions
- Cervical Dysplasia
- Cervical Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 0 Secondary · Reporting Duration: 8-12 weeks
8-12 weeks
Post-Treatment Circulating HPV DNA
Up to 8 weeks
On-Treatment Circulating HPV DNA
Week 0
Pre-Treatment Circulating HPV DNA
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Circulating HPV DNA
1 of 1
Experimental Treatment
100 Total Participants · 1 Treatment Group
Primary Treatment: Circulating HPV DNA · No Placebo Group · N/A
Circulating HPV DNA
DiagnosticTest
Experimental Group · 1 Intervention: NavDx(R) · Intervention Types: DiagnosticTestTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8-12 weeks
Who is running the clinical trial?
NaverisUNKNOWN
1 Previous Clinical Trials
75 Total Patients Enrolled
Northwell HealthLead Sponsor
426 Previous Clinical Trials
462,323 Total Patients Enrolled
Eligibility Criteria
Age 18+ · Female Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- 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.
- 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.
- 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.
- Kang Z, Stevanović 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.
- 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.
- Jeannot E, Becette V, Campitelli M, Calméjane 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. eCollection 2016 Oct.
- 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.
- 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.
- 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.
- Elena Pereira 2022. "Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05606133.
Frequently Asked Questions
Are there any remaining openings in this clinical research initiative?
"Affirmative, clinicaltrials.gov records attest that this research endeavour is actively seeking participants. It was first announced on August 10th 2022 and has since been modified as recently as October 31st 2022. One health facility will be recruiting a total of 100 patients for the trial." - Anonymous Online Contributor
Unverified Answer
To what extent is enrollment available for this clinical trial?
"Affirmative. Perusal of the information hosted on clinicaltrials.gov elucidates that this medical experiment, which was initially posted on August 10th 2022, is presently recruiting patients. Approximately 100 individuals must be recruited at a single institution." - Anonymous Online Contributor
Unverified Answer