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Not yet recruiting NCT07375979

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

— Observational Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: 40 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Primary outcome measures

  • The performance of mult-modal in lung cancer early detection [Time frame: 12 months]
Secondary outcome measures (2)
  • The performance of multi-modal across subgroup analysis [Time frame: 12 months]
  • Comparing the performance of three different modals. [Time frame: 12 months]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

China · 7 centers
  • Shijiazhuang People's Hospital — Shijiazhuang
  • The First Affiliated Hospital of Zhengzhou University — Zhengzhou
  • The First Hospital of Ji Lin University — Changchun
  • Liaoning Cancer Hospital & Institute — Shenyang
  • Shanghai Pulmonary Hospital — Shanghai
  • Shanghai Chest Hospital — Shanghai
  • Yunnan Cancer Hospital — Kunming

Identifiers

NCT: NCT07375979 · CMe-Lung

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗