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

ConditionLung Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-74
SponsorShanghai Pulmonary Hospital, Shanghai, China

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

14,300 Participants
are grouped into 3 trial groups
Group A: CT cohort
Group B: Blood-based cohort
Group C: Multi-modal cohort

Trial outcomes

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

Time frame
12 months

Secondary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12 months

Other outcomes

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: