NCT04064515已完成不适用
Identification of Circulating Tumor Cells in Patients With HPV 16 or 18 Associated Cervical Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
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).
时间窗: 3 Years
次要结局
- 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)
研究者
研究点 (1)
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