CTCs in Cervix Cancer

NYU Langone Health

Status: Completed

Conditions: HPV; Cervical Cancer

Treatments: Diagnostic Test: Blood Assayed for CTCs

Study type: Observational

Funder types: Other

Identifiers

NCT04064515

19-00495

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

4 participants in 2 patient groups

Cervical Cancer

Description:

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.

Treatment:

Diagnostic Test: Blood Assayed for CTCs

Control

Description:

Participants without a history of cervical cancer or high grade pre-cancer of the cervix

Treatment:

Diagnostic Test: Blood Assayed for CTCs