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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04064515
Other study ID # 19-00495
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2, 2020
Est. completion date April 23, 2020

Study information

Verified date August 2022
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date April 23, 2020
Est. primary completion date April 23, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Blood Assayed for CTCs
All study participants will have 15 mL of blood drawn for the purpose of the study.

Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Recurrence rates in patients stratified by CTC identification 3 Years
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