NCT06456281招募中不适用
Development and Validation of Multi-omics Model for Screening of Pancreatic Cancer Using cfDNA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Performance of cfDNA multi-omics model for discriminating pancreatic cancer versus healthy individuals.
研究概览
简要总结
This is a prospective case-control study, aiming at developing a cell free DNA (cfDNA) multi-omics precise diagnostic model for screening of pancreatic cancer.
详细描述
Peripheral blood samples from participants with new diagnosis of pancreatic cancers, precancerous lesions and healthy individuals will be collected to characterize the cancer-specific signatures by low-pass whole-genome sequencing and target methylation sequencing using cfDNA. An ensemble multi-omics model will be trained aided by machine learning algorithm and validated in test set. The performance of this multi-omics model distinguishing pancreatic cancer from non-cancer will be evaluated.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-75 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
- •Physical status score ECOG 0-1
排除标准
- •Pregnancy or lactating women
- •Known prior or current diagnosis of other types of malignancies comorbidities
- •Severe acute infection or febrile illness 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
- •Precancerous Lesions Arm
- •Inclusion Criteria:
- •18-75 years old
- •Diagnosed with pancreatic intraepithelial tumor pancreatic intraepithelial lesions (PanINs), Intraductal papillary mucinous neoplasms (IPMN) or mucinous cystic neoplasms (MCN) by radiographical assess
- •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 or febrile illness 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
- •Healthy Individuals Arm
- •Inclusion Criteria:
- •18-75 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 or febrile illness 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 multi-omics model for discriminating pancreatic cancer versus healthy individuals.
时间窗: 12 months
The area under the curve (AUC), sensitivity and specificity of cfDNA multi-omics model.
次要结局
- Performance of pre-defined model in clinical sub-groups of interest.(12 months)
- Performance of cfDNA multi-omics model for discriminating patients with pancreatic cancer and precancerous lesions versus healthy individuals.(12 months)
- Performance of cfDNA multi-omics model for discriminating precancerous lesions versus healthy individuals.(12 months)
研究者
Xian-Jun Yu
Chair of Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Fudan University
研究点 (1)
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