This study is a multi-center, case-control study aiming at developing and blinded testing machine learning-based multiple cancers early detection model by prospectively collecting blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis.
Eligibility
Sex
ALL
Min age
40 Years
Max age
74 Years
Healthy volunteers
Accepted
Inclusion Criteria for Case Arm Participants:
* 40-74 years old
* Clinically and/or pathologically diagnosed 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
Exclusion Criteria for Case Arm Participants:
* 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.) within 14 days prior to screen
* Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 30 days prior to screen
* Recipients of therapy in past 14 days prior to screen, including oral or IV glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
* Unsuitable for this trial determined by the researchers
Inclusion Criteria for Control Arm Participants:
* 40-74 years old
* Without confirmed cancer diagnosis
* Able to provide a written informed consent and willing to comply with all part of the protocol procedures
Exclusion Criteria for Control Arm Participants:
* 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.) within 14 days prior to screen
* Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 30 days prior to screen
* Recipients of therapy in the past 14 days prior to screen, including oral or IV glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
* Unsuitable for this trial determined by the researchers
Primary outcome measure(s)
The performance of cfDNA methylation-based multiple cancers early detection model in case-control study — 12 months The sensitivity, specificity and tissue origin accuracy of cfDNA methylation-based multiple cancers early detection model in detecting cancer or non-cancer at 95% confidence interval.
Trial sites (8)
Facility
City
Region
Status
Peking University People's Hospital
Beijing
Beijing Municipality
Recruiting
Peking University Cancer Hospital and Institute
Beijing
Beijing Municipality
Active Not Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
China
Active Not Recruiting
The First Hospital of Jilin University
Changchun
China
Active Not Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou
China
Active Not Recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou
China
Active Not Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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