Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
4 participants
OBSERVATIONAL
2020-03-02
2020-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Cervical Cancer
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.
Blood Assayed for CTCs
All study participants will have 15 mL of blood drawn for the purpose of the study.
Control
Participants without a history of cervical cancer or high grade pre-cancer of the cervix
Blood Assayed for CTCs
All study participants will have 15 mL of blood drawn for the purpose of the study.
Interventions
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Blood Assayed for CTCs
All study participants will have 15 mL of blood drawn for the purpose of the study.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
100 Years
FEMALE
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Leslie Boyd, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Other Identifiers
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19-00495
Identifier Type: -
Identifier Source: org_study_id
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