CTCs in Cervix Cancer
Completed
- Conditions
- HPVCervical Cancer
- Registration Number
- NCT04064515
- Lead Sponsor
- NYU Langone Health
- 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 of the HPV 16 / 18 E6 protein, confirming a cervical cancer origin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 4
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Recurrence rates in patients stratified by CTC identification 3 Years
Trial Locations
- Locations (1)
NYU Langone Health
🇺🇸New York, New York, United States
NYU Langone Health🇺🇸New York, New York, United States