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

NCT07375979 | Not Yet Recruiting

• 1 other identifier: CMe-Lung
• Study Type: observational
• Target: 14,300
• Locations: 1 country
• Sites: 7

Brief Summary

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).

Conditions

Lung Cancer

Keywords

multi-modal; CT and cfDNA methylation; lung cancer early detection

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (2)

• The performance of multi-modal across subgroup analysis

  12 months

• Comparing the performance of three different modals.

  12 months

Study Arms (3)

CT cohort

Lung cancer patients or healthy individuals who can provide CT scan

Blood-based cohort

Blood based cfDNA methylation information retrieved from Profound study

Multi-modal cohort

Retrospective collect paired CT and blood based cfDNA methylation information from Profound study

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

lung cancers or healthy individuals who can provide imaging data meeting the inclusion and exclusion criteria

You may qualify if:

• 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
• years old
• Without confirmed cancer diagnosis
• Able to provide a written informed consent and willing to comply with all part of the protocol procedures
• 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

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead
• 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

Study Sites (7)

Shijiazhuang People's Hospital

Shijiazhuang, Hebei, 050026, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

The First Hospital of Ji Lin University

Changchun, Jilin, 130021, China

Location

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110801, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Yunnan Cancer Hospital

Kunming, Yunnan, 650100, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: February 5, 2026
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

CN (7)