CTCs in Cervix Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Identification of Circulating Tumor Cells in Patients With HPV 16 or 18 Associated Cervical Cancer

Conditions
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Cervical Cancer, HPV

Intervention / Treatment
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* Diagnostic Test: Blood Assayed for CTCs


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cervical Cancer<br>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. | Diagnostic Test: Blood Assayed for CTCs<br>* All study participants will have 15 mL of blood drawn for the purpose of the study.<br>|
| Control<br>Participants without a history of cervical cancer or high grade pre-cancer of the cervix | Diagnostic Test: Blood Assayed for CTCs<br>* All study participants will have 15 mL of blood drawn for the purpose of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |