Lung Cancer Diagnosis by Detecting Epigenetic Imprinting Alterations in Bronchoalveolar Lavage

NCT05707585 | Unknown

• 1 other identifier: LungCancerImprintingDiagnosis
• Study Type: observational
• Target: 2,064
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Cancer

Keywords

Genomic Imprinting; Epigenetics; Diagnostic Study; Bronchoalveolar Lavage

Outcome Measures

Primary Outcomes (1)

• Epigenetic Imprinting Diagnostic Score

  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

Interventions

Quantitative Chromogenic Imprinted Gene in situ Hybridization (QCIGISH) DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with pulmonary nodules and meet the criteria of bronchoscopy examination

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (3)

Zongda Hospital affiliated to Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116023, China

RECRUITING

Zhongshan Hospital Fudan University

Shanghai, 200032, China

RECRUITING

Related Publications (8)

• Jelinic P, Shaw P. Loss of imprinting and cancer. J Pathol. 2007 Feb;211(3):261-8. doi: 10.1002/path.2116.

  PMID: 17177177 BACKGROUND

• Bartolomei MS, Tilghman SM. Genomic imprinting in mammals. Annu Rev Genet. 1997;31:493-525. doi: 10.1146/annurev.genet.31.1.493.

  PMID: 9442905 BACKGROUND

• Ribarska T, Goering W, Droop J, Bastian KM, Ingenwerth M, Schulz WA. Deregulation of an imprinted gene network in prostate cancer. Epigenetics. 2014 May;9(5):704-17. doi: 10.4161/epi.28006. Epub 2014 Feb 10.

  PMID: 24513574 BACKGROUND

• Matouk IJ, Halle D, Gilon M, Hochberg A. The non-coding RNAs of the H19-IGF2 imprinted loci: a focus on biological roles and therapeutic potential in Lung Cancer. J Transl Med. 2015 Apr 9;13:113. doi: 10.1186/s12967-015-0467-3.

  PMID: 25884481 BACKGROUND

• Ito Y, Koessler T, Ibrahim AE, Rai S, Vowler SL, Abu-Amero S, Silva AL, Maia AT, Huddleston JE, Uribe-Lewis S, Woodfine K, Jagodic M, Nativio R, Dunning A, Moore G, Klenova E, Bingham S, Pharoah PD, Brenton JD, Beck S, Sandhu MS, Murrell A. Somatically acquired hypomethylation of IGF2 in breast and colorectal cancer. Hum Mol Genet. 2008 Sep 1;17(17):2633-43. doi: 10.1093/hmg/ddn163. Epub 2008 Jun 9.

  PMID: 18541649 BACKGROUND

• Shen R, Cheng T, Xu C, Yung RC, Bao J, Li X, Yu H, Lu S, Xu H, Wu H, Zhou J, Bu W, Wang X, Si H, Shi P, Zhao P, Liu Y, Deng Y, Zhu Y, Zeng S, Pineda JP, Lin C, Zhou N, Bai C. Novel visualized quantitative epigenetic imprinted gene biomarkers diagnose the malignancy of ten cancer types. Clin Epigenetics. 2020 May 24;12(1):71. doi: 10.1186/s13148-020-00861-1.

  PMID: 32448196 BACKGROUND

• Xu H, Zhang Y, Wu H, Zhou N, Li X, Pineda JP, Zhu Y, Fu H, Ying M, Yang S, Bao J, Yang L, Zhang B, Guo L, Sun L, Lu F, Wang H, Huang Y, Zhu T, Wang X, Wei Q, Sheng C, Qu S, Lv Z, Xu D, Li Q, Dong Y, Qin J, Cheng T, Xing M. High Diagnostic Accuracy of Epigenetic Imprinting Biomarkers in Thyroid Nodules. J Clin Oncol. 2023 Feb 20;41(6):1296-1306. doi: 10.1200/JCO.22.00232. Epub 2022 Nov 15.

  PMID: 36378996 BACKGROUND

• Zhou J, Cheng T, Li X, Hu J, Li E, Ding M, Shen R, Pineda JP, Li C, Lu S, Yu H, Sun J, Huang W, Wang X, Si H, Shi P, Liu J, Chang M, Dou M, Shi M, Chen X, Yung RC, Wang Q, Zhou N, Bai C. Epigenetic imprinting alterations as effective diagnostic biomarkers for early-stage lung cancer and small pulmonary nodules. Clin Epigenetics. 2021 Dec 14;13(1):220. doi: 10.1186/s13148-021-01203-5.

  PMID: 34906185 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Disease

Interventions

In Situ Hybridization

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Nucleic Acid Hybridization; Genetic Techniques

Study Officials

• Qi Wang, MD

  The Second Affiliated Hospital of Dalian Medical University

  STUDY DIRECTOR

Central Study Contacts

Encheng Li, MD

CONTACT

+86-411-84671291; doctorliencheng@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 1, 2023
• Study Start: January 29, 2023
• Primary Completion: January 15, 2024
• Study Completion: July 15, 2024
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)