CTCs in Cervix Cancer

Identification of Circulating Tumor Cells in Patients With HPV 16 or 18 Associated Cervical Cancer

This study is a validation study to confirm the ability of Telomescan OBP-401 to identify CTCs in patients with HPV 16 / 18 associated cervical cancer. CTCs identified will be tested for the presence of the HPV 16 / 18 E6 protein, confirming a cervical cancer origin.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; HPV
• Intervention / Treatment: Diagnostic test: Blood Assayed for CTCs

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Two groups will be recruited: the case group will consist of 16 participants with advanced or recurrent cervical cancer; the control arm will consist of 16 participants without a history of cervical cancer or high grade pre-cancer of the cervix.

Description

Inclusion Criteria:

• Able to safely provide 15 ml of blood
• Able to provide informed consent
• Pathologically confirmed invasive cervical cancer
• Proof of serotype HPV 16 or HPV 18 positive within 3 years of the study
• Patients with stages IIA2 to IVB OR recurrent cervical cancer
• For patients with newly diagnosed cervical cancer, they must be enrolled (blood drawn) prior to initiating anti-cancer therapy
• For patients with recurrent cervical cancer, they must be enrolled (blood drawn) prior to initiating a new anti-cancer therapy for progression of disease (based on RECIST 1.1 criteria). Patients who have progressed and are moving to best supportive care are eligible.
• If patients meet criteria 5.1A 5 above, the following criteria must be met:
• At least 21 days have elapsed following treatment with cytotoxic chemotherapy
• At least 14 days have elapsed following treatment with biologic therapy
• At least 14 days have elapsed following radiation therapy

Exclusion Criteria:

• History of any cancer other than cervix cancer within the past five years.
• History of any known germ-line pathogenic mutation (ie BRCA 1 / 2 or Lynch syndrome, but genetic testing is not required)
• Current use of systemic corticosteroids at doses exceeding 10 mg per day of prednisone or its equivalent.
• Active infection including hepatitis B, hepatitis C, HIV.
• Any patient unable to comply with the study criteria.
• Patients taking any anti-inflammatory agents (aspirin, NSAIDs, steroids), within 24 hrs prior to blood draw.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cervical Cancer; Participants with advanced or recurrent cervical cancer will provide 15 mL of whole blood. Participants will then be followed prospectively for three years to document oncologic outcome.	Diagnostic test: Blood Assayed for CTCs; All study participants will have 15 mL of blood drawn for the purpose of the study.
Control; Participants without a history of cervical cancer or high grade pre-cancer of the cervix	Diagnostic test: Blood Assayed for CTCs; All study participants will have 15 mL of blood drawn for the purpose of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effectiveness of OBP-401 to identify CTCs in patients with active HPV 16 / 18 associated cervical cancer compared to non-cancer controls (patients without CIN 2 - 3 or cancer).	3 Years

Secondary Outcome Measures

Outcome Measure	Time Frame
Presence of HPV 16 or 18 genome in the samples with a positive CTC result, in order to confirm a cervical cancer origin.	3 Years
Recurrence rates in patients stratified by CTC identification	3 Years

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Leslie Boyd, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2020
• Primary Completion (ACTUAL): April 23, 2020
• Study Completion (ACTUAL): April 23, 2020

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (ACTUAL): August 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: 19-00495

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No