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Trial Title:
Lung Cancer Diagnosis by Detecting Epigenetic Imprinting Alterations in Bronchoalveolar Lavage
NCT ID:
NCT05707585
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Genomic Imprinting
Epigenetics
Diagnostic Study
Bronchoalveolar Lavage
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Quantitative Chromogenic Imprinted Gene in situ Hybridization (QCIGISH)
Description:
Visualize and quantify the allelic expression status of imprinted genes by in situ
hybridization using probes targeting the nascent RNAs
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.
Criteria for eligibility:
Study pop:
Patients with pulmonary nodules and meet the criteria of bronchoscopy examination
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zongda Hospital affiliated to Southeast University
Address:
City:
Nanjing
Zip:
210009
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming Ding, MD
Phone:
+8618951610130
Email:
maolading_527@sina.com
Facility:
Name:
The Second Affiliated Hospital of Dalian Medical University
Address:
City:
Dalian
Zip:
116023
Country:
China
Status:
Recruiting
Contact:
Last name:
Encheng Li, MD
Phone:
+86-411-84671291
Email:
doctorliencheng@163.com
Facility:
Name:
Zhongshan Hospital Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Zhou, PhD
Phone:
+8618221223320
Email:
zhou.jian@fudan.edu.cn
Start date:
January 29, 2023
Completion date:
July 15, 2024
Lead sponsor:
Agency:
The Second Affiliated Hospital of Dalian Medical University
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Zongda Hospital affiliated to Southeast University
Agency class:
Other
Collaborator:
Agency:
West China Hospital
Agency class:
Other
Collaborator:
Agency:
Henan Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
First Hospital of China Medical University
Agency class:
Other
Collaborator:
Agency:
Shengjing Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Lisen Imprinting Diagnostics, Inc.
Agency class:
Other
Source:
The Second Affiliated Hospital of Dalian Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05707585
