This study is a multi-center, observational study aiming to develop an early screening multi-model for detecting lung cancer signals through the integration of imaging (non-contrast CT) and blood testing (cfDNA methylation).
Eligibility
Sex
ALL
Min age
40 Years
Max age
74 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 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:
* 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 ≥ 38.5 °C) 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 antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
* Unsuitable for this trial determined by the researchers
* Low-quality samples: images only partially showing the lungs or in lateral decubitus position, unreadable due to severe motion artifacts/metal artifacts, or with missing critical metadata
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.) or febrile illness (body temperature of ≥ 38.5 °C) 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 antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
* Unsuitable for this trial determined by the researchers
* Low-quality samples: images only partially showing the lungs or in lateral decubitus position, unreadable due to severe motion artifacts/metal artifacts, or with missing critical metadata
Primary outcome measure(s)
The performance of mult-modal in lung cancer early detection — 12 months The sensitivity, specificity and AUC for lung cancer early detection in detecting cancer or non-cancer at 95% confidence interval
Trial sites (7)
Facility
City
Region
Status
Shijiazhuang People's Hospital
Shijiazhuang
Hebei
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
The First Hospital of Ji Lin University
Changchun
Jilin
Liaoning Cancer Hospital & Institute
Shenyang
Liaoning
Shanghai Pulmonary Hospital
Shanghai
Shanghai Municipality
Shanghai Chest Hospital
Shanghai
Shanghai Municipality
Yunnan Cancer Hospital
Kunming
Yunnan
More Shanghai Pulmonary Hospital, Shanghai, China trials in China
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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