A Proof of Concept Study of Pancreatic Cancer Early Detection by cfDNA Assay
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 276
- 试验地点
- 3
- 主要终点
- Performance of cfDNA methylation-based model for discriminating pancreatic cancer versus non-cancer
研究概览
简要总结
This study is a multi-center, observational study aiming at developing a machine learning-based early detection model using prospectively collected liquid biopsy samples from clinically-annotated individuals.
详细描述
Peripheral blood samples from participants with new diagnosis of pancreatic cancers will be collected to characterize the cancer-specific circulating signals by sequencing cell free DNA. A noninvasive test integrating machine learning algorithm will be trained and validated through a two-stage approach in recruited well-classified individuals, along with non-cancers without clinical diagnosis of cancer after routine medical screening. The performance of liquid biospy assays discovering cancer from non-cancer will be evaluated in participants with benign disease as well as average risk individuals.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-75 years old
- •Clinically and/or pathologically diagnosed pancreatic cancer
- •No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
- •Able to provide a written informed consent and willing to comply with all part of the protocol procedures.
排除标准
- •Pregnancy or lactating women
- •Known prior or current diagnosis of other types of malignancies comorbidities
- •Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.0 °C) within 14 days prior to blood draw
- •Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- •Recipients of blood transfusion within 30 days prior to study blood draw
- •Recipients of therapy in past 14 days prior to blood draw, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide
- •Other conditions that the investigators considered are not suitable for the enrollment
- •Benign Disease Arm
- •Inclusion Criteria:
- •40-75 years old
- •Clinically and/or pathologically diagnosed pancreatic non-malignant disease (pancreatic intraepithelial neoplasia, pancreatic cyst and chronic pancreatitis)
- •No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
- •Able to provide a written informed consent and willing to comply with all part of the protocol procedures
- •Exclusion Criteria:
- •Pregnancy or lactating women
- •Known prior or current diagnosis of other types of malignancies comorbidities
- •Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.0 °C) within 14 days prior to blood draw
- •Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- •Recipients of blood transfusion within 30 days prior to study blood draw
- •Recipients of therapy in past 14 days prior to blood draw, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide
- •Other conditions that the investigators considered are not suitable for the enrollment
结局指标
主要结局
Performance of cfDNA methylation-based model for discriminating pancreatic cancer versus non-cancer
时间窗: 12 months
Sensitivities of cfDNA methylation-based model at specificity of 99% and 95%, respectively.
次要结局
- Performance of models using multi-omic data for discriminating pancreatic cancer versus non-cancer(12 months)
- Performance of pre-defined model in clinical sub-groups of interest(12 months)
研究者
Xian-Jun Yu
Principal Investigator
Fudan University