CTCs in Cervix Cancer

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04064515
• Other study ID #: 19-00495
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Cervical Cancer
• HPV
• Uterine Cervical Neoplasms

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