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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07375979

Enrollment

14300

Registered

2026-01-29

Start date

2026-02-05

Completion date

2026-09-01

Last updated

2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

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

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).

Detailed description

This study aims to develop three modality -based models for lung cancer early screening, incuding a CT-based imaging model, a blood-based cfDNA methylation model, and a multimodal framework. First, 10,700 retrospective non-contrast CT scans will be collected to construct the CT imaging-based model. This model will extract multi- scale structural features through a hierarchical modeling framework, enabling the learning of interpretable spatial representations. Second, cfDNA methylation data from lung cancer patients and healthy individuals enrolled in the ProFound study (NCT06217900) wll be used to develop the blood-based model. Third, subjects with paired CT imaging and cfDNA methylation data from the ProFound study will be included to construct a multimodal model by integrating information across modalities. The performance of models based on different modalities will be systematically compared to evaluate their respective and complementary contributions to lung cancer early screening.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 74 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

Measure	Time frame	Description
The performance of multi-modal across subgroup analysis	12 months	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.	12 months	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.

Countries

China

Outcome results