Lung Cancer Diagnosis by Detecting Epigenetic Imprinting Alterations in Bronchoalveolar Lavage

NCT ID: NCT05707585

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2064 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-29
• Study Completion Date: 2024-07-15

Brief Summary

The goal of this multicenter observational study is to evaluate the lung cancer diagnostic value of epigenetic imprinting detection in bronchoalveolar lavage. This study will mainly focus on varifing the previously identified epigenetic imprinting biomarkers for lung cancer and upgrading and validating a lung cancer imprinting diagnostic model specifically for bronchoalveolar lavage. The lavage sample will be collected from each eligible paticipants under bronchialscopy and undergo QCIGISH detection to analyze the allelic expression status of imprinted genes. The QCIGISH detection results will be compared with the final surgical histopathology. No interventions will be taken according to the QCIGISH detection results.

Detailed Description

Bronchial biopsy and bursh are widely used in lung cancer diagnosis but not bronchoalveolar lavage because of its low sensitivity. As the molecular alterations usually occur before the morphological changes, genetic and epigenetic biomarkers will be helpful for early diagnosis of cancers. As an important epigenetic regulation in mammalian embryo development, genomic imprinting plays important roles in cancers. In normal post-natal somatic cells, imprinted genes are "silenced", that is mono-allelically expressed either from the maternal or paternal allele, while in cancers, some silenced imprinting genes' copies could be reactivated, leading to expressions from both alleles. The loss of monoallelic gene regulation is named loss of imprinting (LOI), and has been previously found in various human cancers. Our previous studies has identified several imprinted genes with elevated aberrant allelic expressions in lung cancer. A diagnostic model based on the epigenetic imprinting biomarkers achieved 99.1% sensitivity and 92.1% specificity. In this study, we will first verify the epigenetic imprinting biomarkers in bronchoalveolar lavage, and refine the previously developed diagnostic model specifically for lavage samples. The diagnostic model will be independently validated in a group of prospectively enrolled cases. This study will help to distinguish benign and malignant pulmonary nodules presurgically, and improve the early diagnosis of lung cancer.

Conditions

Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Quantitative Chromogenic Imprinted Gene in situ Hybridization (QCIGISH)

Visualize and quantify the allelic expression status of imprinted genes by in situ hybridization using probes targeting the nascent RNAs

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old, and ≤ 75 years old;
• Chest CT showed pulmonary nodule with diameter<3cm;
• Subjects voluntarily participated and signed the informed consent form.

Exclusion Criteria

• Active massive hemoptysis;
• Severe heart and lung dysfunction;
• Severe arrhythmia;
• Extreme exhaustion of general condition;
• Coagulation dysfunction;
• Acute attack of asthma;
• Aortic aneurysm.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: collaborator

Zongda Hospital affiliated to Southeast University

NETWORK

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

First Hospital of China Medical University

OTHER

Sponsor Role: collaborator

Shengjing Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Lisen Imprinting Diagnostics, Inc.

UNKNOWN

Sponsor Role: collaborator

The Second Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qi Wang, MD

Role: STUDY_DIRECTOR

The Second Affiliated Hospital of Dalian Medical University

Locations

Zongda Hospital affiliated to Southeast University

Nanjing, Jiangsu, China

Site Status: RECRUITING

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status: RECRUITING

Zhongshan Hospital Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Encheng Li, MD

Role: CONTACT

doctorliencheng@163.com

+86-411-84671291

Facility Contacts

Ming Ding, MD

Role: primary

maolading_527@sina.com

+8618951610130

Encheng Li, MD

Role: primary

doctorliencheng@163.com

+86-411-84671291

Jian Zhou, PhD

Role: primary

zhou.jian@fudan.edu.cn

+8618221223320

References

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Reference Type: BACKGROUND

PMID: 17177177 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 9442905 (View on PubMed)

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Other Identifiers

LungCancerImprintingDiagnosis

Identifier Type: -

Identifier Source: org_study_id