Status:
COMPLETED
CTCs in Cervix Cancer
Lead Sponsor:
NYU Langone Health
Conditions:
Cervical Cancer
HPV
Eligibility:
FEMALE
18-100 years
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 23 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04064515
Start Date
March 2 2020
End Date
April 23 2020
Last Update
August 5 2022
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016