About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
lung cancers or healthy individuals who can provide imaging data meeting the inclusion and exclusion criteria
Trial design
Case-control
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
The performance of mult-modal in lung cancer early detection
The sensitivity, specificity and AUC for lung cancer early detection in detecting cancer or non-cancer at 95% confidence interval
Secondary outcomes
The performance of multi-modal across subgroup analysis
Sensitivity and 95% confidence intervals of multimodal approach (imaging combined with blood-based methylation testing) across different stages, pathological subtypes, gender, age, and risk factor subgroups.
Comparing the performance of three different modals.
Comparison of sensitivity, specificity, and 95% confidence intervals among imaging modality, blood-based methylation testing modality, and multimodal approach (imaging combined with blood-based methylation testing) in lung cancer early screening.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Pulmonary Hospital, Shanghai, China
Lead sponsor
Shanghai Chest Hospital
Collaborator
Liaoning Cancer Hospital & Institute
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Yunnan Cancer Hospital
Collaborator
Shijiazhuang People's Hospital
Collaborator
The First Hospital of Jilin University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: