NCT04308720进行中（未招募）不适用
Circulating Tumor DNA (ctDNA) and Immunophenotyping as Potential Biomarkers in Patients Undergoing Regional Nodal Irradiation for Breast Cancer
适应症
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
- 217
- 试验地点
- 1
- 主要终点
- Changes in the ctDNA detection
研究概览
简要总结
This study will assess how radiation affects the patterns of circulating tumor deoxyribonucleic acid (ctDNA) and immune cells (T cells) during radiation treatment in patients with breast cancer. By better understanding how radiation therapy affects these markers (characteristic that is measured to see how well the body responds to a treatment for a disease) in the blood, researchers may better customize treatments for patients with breast cancer in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years of age or older
- •Histologically confirmed primary or recurrent non-metastatic invasive breast cancer with plans for adjuvant post-lumpectomy or post-mastectomy radiation therapy at the Mayo Clinic and indications for regional nodal irradiation.
- •Or patients undergoing curative intent irradiation for oligometastatic breast cancer (=< 3 sites of metastases) is permitted
- •Willingness to provide informed consent and expresses understanding of this protocol and its requirements, risks, and discomforts
- •Patients with non-metastatic breast cancer must have completed their final breast surgery including re-excision of margins for invasive cancer and ductal carcinoma in situ (DCIS) or chemotherapy within 90 days prior to registration but no sooner than 21 days prior to the initiation of radiation therapy (RT).
- •Bilateral breast cancer is permitted
- •Positive or close margins is allowed
排除标准
- •Other active malignancy =< 2 years prior to registration (exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix)
- •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
Changes in the ctDNA detection
时间窗: Baseline to 3 months post-treatment (treatment typically lasts 3-6 weeks)
Assessed by the number of patients who have undetectable ctDNA post-treatment, among patients that were detectable pre-treatment.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
撤回
不适用
A Study of the Role of Circulating Tumor DNA in Predicting the Likelihood of Organ Preservation After Clinical Complete Response to Neoadjuvant Therapy for Rectal CancerGastrointestinal MalignanciesNCT03749083Massachusetts General Hospital
招募中
不适用
ctDNA-based MRD Assessment in Local Advanced Esophageal CarcinomaEsophageal Squamous Cell CarcinomaNCT05426850Fudan University100
尚未招募
不适用
ctDNA and Organ Preservation/Pathologic CR in Rectal CancerRectal CancerNon Metastatic Rectal CancerNCT05629442Massachusetts General Hospital60
已完成
不适用
The Implication of Plasma ctDNA Methylation Haplotypes in Detecting Colorectal Cancer and AdenomasAdenomaColorectal CancerNCT03737591Fudan University1,138
终止
不适用
Temporal Pattern of Circulating DNA for Patients Receiving IrradiationRadiationNCT01099020University of Rochester13