A Multi-modal Integrating Imaging and Cell-free DNA Methylation in Lung Cancer Early Detection (CMe-Lung): a Multi-center, Observational Study

Starting soon

Conditions studied: Lung Cancer

In brief

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).

Key facts

Study ID

NCT07375979

Run by

Shanghai Pulmonary Hospital, Shanghai, China

People needed

14300

Starts

2026-02-05

Expected to finish

2026-09-01

Last updated by the study team

2026-01-29

Who can join

Age: 40 and older, up to 74. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shijiazhuang People's Hospital — Shijiazhuang, Hebei, China
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
• The First Hospital of Ji Lin University — Changchun, Jilin, China
• Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China
• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China
• Yunnan Cancer Hospital — Kunming, Yunnan, China

Full record on ClinicalTrials.gov

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