Cervical Cancer, HPV
Conditions
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.
Interventions
DIAGNOSTIC_TESTBlood Assayed for CTCs
All study participants will have 15 mL of blood drawn for the purpose of the study.
Sponsors
NYU Langone Health
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed