PaCIFiC-CUP：Pan-Cancer Integrated Fingerprinting Classifier for Identifying the Origin of Cancer of Unknown Primary: A Multi-Center Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This study aims to initially utilize machine learning on pan-cancer DNA methylation data from public databases to construct a DNA methylation classification model (PaCIFiC-CUP, pan-cancer integrated fingerprinting classifier of CUP) for diagnosing various types of cancer, particularly the primary site of cancer of unknown primary. The goal is to achieve diagnosis of cancer pathology type by analyzing the DNA methylation patterns of cancer specimens, thereby guiding subsequent precision treatment for cancer.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient specimens were obtained from the Sun Yat-sen University Cancer Center and affiliated cooperating centers, with written consent from the patients authorizing the use of the specimens for research purposes.
- •Following standard assessments (medical history, physical examination, complete blood count, biochemistry, computed tomography scans of the neck, chest, abdomen, and pelvis, targeted evaluations of all symptomatic areas, pathology, and immunohistochemistry), the diagnosis was determined as a primary site unknown tumor (including adenocarcinoma, squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma, sarcoma, etc).
- •The diagnosis was confirmed at the participating institution and the patient had received systemic therapy.
- •Complete clinical, pathological, and follow-up data for the patients can be obtained.
- •ECOG performance status score: 0-2 points.
排除标准
- •Pregnant or lactating female patients.
- •Tumor tissue sample size is too small (tumor tissue accounts for <70% in the biopsy or slice tissue).
- •Organ transplant or history of non-autologous (allogeneic) bone marrow or stem cell transplantation.
- •History of previous tumors, with the current condition being a recurrent tumor.
- •Hematological malignancies (excluding lymphoma).
- •Other diseases that may severely impact patient survival, such as severe cardiovascular or cerebrovascular diseases, sepsis, severe trauma or burns, etc.
研究组 & 干预措施
Site-Specific Therapy Group
These patients with cancer of unknown primary received site-specific therapy that matched the particular site predicted by the DNA methylation classifier.
Empirical Therapy Group
These patients with cancer of unknown primary received empirical therapy that didn't match the particular site predicted by the DNA methylation classifier.
结局指标
主要结局
Overall Survival
时间窗: From date of diagnosis until the date of death from any cause, assessed up to 24 months
Overall survival refers to the length of time that a person lives after being diagnosed with cancer of unknown primary, without regard to any specific cause of death.
次要结局
- Progression-Free Survival(From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
研究者
Xiao-Peng Tian
Principal Investigator
Sun Yat-sen University