Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Proportion of patients with undetectable circulating tumor deoxyribonucleic acid (ctDNA) posttreatment in patients with detectable ctDNA pre-treatment
研究概览
简要总结
This study collects blood samples to determine if the DNA of HPV that causes cervical cancer can be detected in patients with cervical cancer that is new (primary), has come back (recurrent), or has spread to other places in the body (metastatic) and are undergoing treatment with surgery, radiotherapy, chemotherapy, and/or immunotherapy. Researchers may use this information to predict response (good or bad) of the cervical cancer to treatment and detect recurrent cancer sooner.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the ctDNA detection rate in cervix cancer patients undergoing surgery, radiotherapy, chemotherapy, and/or immunotherapy in the setting of primary, recurrent or metastatic disease.
II. Association of ctDNA baseline levels and clearance kinetics with clinical and radiographic tumor response.
III. To explore the association of detectable ctDNA at each time point with invasive recurrence-free survival and overall survival.
IV. To explore the use of ctDNA for surveillance and detection of disease recurrence.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to provide written consent
- •Patient has given permission to give tumor/blood sample for research testing
- •Histological confirmation of adenocarcinoma, adenosquamous, or small cell carcinoma of the cervix
- •Known HPV status defined as positive staining for p16 on IHC or DNA ISH for HPV
- •Willingness to return to enrolling institution (Mayo Clinic Rochester or the University of Minnesota) for follow-up (during the Active Monitoring Phase of the study) or complete blood draws locally using study mail-in kits
- •Consent to allow blood specimens to be shared with Mayo Clinic study personnel and potential external collaborators for sample analysis
- •Definitive Chemoradiotherapy for Locally Advanced Disease (FIGO Stage IB2-IIIC)
- •FIGO 2019 Stage IB2-IIIC or not a surgical candidate
- •Plan to undergo definitive chemoradiotherapy including external beam radiotherapy, brachytherapy, and chemotherapy
排除标准
- •Other active malignancy =< 2 years prior to registration.
- •EXCEPTIONS: Non-melanotic skin cancer
- •NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for cancer
- •Pregnancy or lactation
- •Inability on the part of the patient to understand the informed consent to be compliant with the protocol
结局指标
主要结局
Proportion of patients with undetectable circulating tumor deoxyribonucleic acid (ctDNA) posttreatment in patients with detectable ctDNA pre-treatment
时间窗: At 6 weeks post-surgery (cohort 1), at 4-6 weeks after completion of chemotherapy and radiation (cohort 2), 4-6 weeks post End of chemotherapy and radiotherapy (cohort 3), at 8 weeks after start of chemotherapy or immunotherapy (cohort 4)
The proportion will be reported along with the exact 95% binomial confidence interval. Additionally will report the mean standard deviation and median interquartile range ctDNA post-treatment in these patients.
次要结局
- Clinical tumor response(At post-treatment assessment, assessed up to 2 years)
- Overall survival(Up to 2 years)
- ctDNA clearance kinetics(Up to 2 years)
- ctDNA levels(Baseline)
- Radiographic tumor response(At post-treatment assessment, assessed up to 2 years)
- ctDNA conversion(Up to 2 years)
- Recurrence-free survival(Up to 2 years)