Lung Cancer Diagnosis by Detecting Epigenetic Imprinting Alterations in Bronchoalveolar Lavage

January 29, 2023 updated by: The Second Affiliated Hospital of Dalian Medical University

A Multicenter Study for Evaluating the Benign and Malignant Pulmonary Noldules by Detecting the Epigenetic Imprinting Alterations in Bronchoalveolar Lavage

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

2064

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital Fudan University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zongda Hospital affiliated to Southeast University
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116023
        • Recruiting
        • The Second Affiliated Hospital of Dalian Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with pulmonary nodules and meet the criteria of bronchoscopy examination

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epigenetic Imprinting Diagnostic Score
Time Frame: Within 10 days after each sample collected
Cancer risk scores calculated by combining the biallelic expressions, multiallelic expressions and total expressions of several imprinted genes
Within 10 days after each sample collected

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Dalian Medical University

Collaborators

Fudan University
West China Hospital
Shengjing Hospital
The First Affiliated Hospital of Guangzhou Medical University
Henan Provincial People's Hospital
First Hospital of China Medical University
Zongda Hospital affiliated to Southeast University
Lisen Imprinting Diagnostics, Inc.

Investigators

  • Study Director: Qi Wang, MD, The Second Affiliated Hospital of Dalian Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 29, 2023

Primary Completion (ANTICIPATED)

January 15, 2024

Study Completion (ANTICIPATED)

July 15, 2024

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

January 29, 2023

First Posted (ACTUAL)

February 1, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2023

Last Update Submitted That Met QC Criteria

January 29, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LungCancerImprintingDiagnosis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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