Sponsors

Lead Sponsor

NYU Langone Health

Age

18 - 100 years

Sex

FEMALE

Healthy Volunteers

No

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.

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What this study is about

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Sponsors

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Trial snapshot

Condition

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For caregivers