Lung CancerNCT05707585
Lung Cancer Diagnosis by Detecting Epigenetic Imprinting Alterations in Bronchoalveolar Lavage
An observational study of Lung Cancer, run by The Second Affiliated Hospital of Dalian Medical University at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Quantitative Chromogenic Imprinted Gene in situ Hybridization (QCIGISH)
- How many people
- 2,064 participants
- Where
- 3 sitesChina
- Study dates
- 29 Jan 2023to 15 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pulmonary nodules and meet the criteria of bronchoscopy examination
Who may be able to join
- 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.
Who cannot join
- Active massive hemoptysis;
- Severe heart and lung dysfunction;
- Severe arrhythmia;
- Extreme exhaustion of general condition;
- Coagulation dysfunction;
- Acute attack of asthma;
- Aortic aneurysm.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116023
Encheng Li, MD, +86-411-84671291, doctorliencheng@163.com
- Recruiting
Zongda Hospital affiliated to Southeast University
Nanjing, Jiangsu, 210009
Ming Ding, MD, +8618951610130, maolading_527@sina.com
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, 200032
Jian Zhou, PhD, +8618221223320, zhou.jian@fudan.edu.cn
About this study
Official title: 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.
Read the 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
- Being tested
- Quantitative Chromogenic Imprinted Gene in situ Hybridization (QCIGISH)
- Keywords
- Genomic Imprinting, Epigenetics, Diagnostic Study, Bronchoalveolar Lavage
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigenetic Imprinting Diagnostic Score
Cancer risk scores calculated by combining the biallelic expressions, multiallelic expressions and total expressions of several imprinted genes
Measured: Within 10 days after each sample collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start29 Jan 2023
- Primary completion15 Jan 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,064 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Zongda Hospital affiliated to Southeast University, West China Hospital, Henan Provincial People's Hospital, First Hospital of China Medical University, Shengjing Hospital, The First Affiliated Hospital of Guangzhou Medical University, Lisen Imprinting Diagnostics, Inc.
- Responsible party
- Sponsor
- Investigators
- Qi Wang, MD, Study director, The Second Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707585
- Sponsor's protocol ID
- LungCancerImprintingDiagnosis
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jelinic P, Shaw P. Loss of imprinting and cancer. J Pathol. 2007 Feb;211(3):261-8. doi: 10.1002/path.2116.
PubMed 17177177Bartolomei MS, Tilghman SM. Genomic imprinting in mammals. Annu Rev Genet. 1997;31:493-525. doi: 10.1146/annurev.genet.31.1.493.
PubMed 9442905Ribarska 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.
PubMed 24513574Matouk 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.
PubMed 25884481Ito 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.
PubMed 18541649Shen 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.
PubMed 32448196Xu 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.
PubMed 36378996Zhou 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.
PubMed 34906185
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study for Evaluating the Benign and Malignant Pulmonary Noldules by Detecting the Epigenetic Imprinting Alterations in Bronchoalveolar Lavage
- ClinicalTrials.gov ID
- NCT05707585
- Acronym / sponsor ID
- LungCancerImprintingDiagnosis
- Conditions
- Lung Cancer
- Keywords
- Genomic Imprinting, Epigenetics, Diagnostic Study, Bronchoalveolar Lavage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,064 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Collaborators
- Fudan University, Zongda Hospital affiliated to Southeast University, West China Hospital, Henan Provincial People's Hospital, First Hospital of China Medical University, Shengjing Hospital, The First Affiliated Hospital of Guangzhou Medical University, Lisen Imprinting Diagnostics, Inc.
- Study start
- 29 Jan 2023 (actual)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pulmonary nodules and meet the criteria of bronchoscopy examination
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Active massive hemoptysis;
- Severe heart and lung dysfunction;
- Severe arrhythmia;
- Extreme exhaustion of general condition;
- Coagulation dysfunction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Background: PubMed 17177177Jelinic P, Shaw P. Loss of imprinting and cancer. J Pathol. 2007 Feb;211(3):261-8. doi: 10.1002/path.2116.
- Background: PubMed 9442905Bartolomei MS, Tilghman SM. Genomic imprinting in mammals. Annu Rev Genet. 1997;31:493-525. doi: 10.1146/annurev.genet.31.1.493.
- Background: PubMed 24513574Ribarska 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.
- Background: PubMed 25884481Matouk 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.
- Background: PubMed 18541649Ito 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.
- Background: PubMed 32448196Shen 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.
- Background: PubMed 36378996Xu 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.
- Background: PubMed 34906185Zhou 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.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qi Wang, MD study director
The Second Affiliated Hospital of Dalian Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by The Second Affiliated Hospital of Dalian Medical University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Encheng Li, MD (+86-411-84671291, doctorliencheng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epigenetic Imprinting Diagnostic Score (time frame: Within 10 days after each sample collected). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05707585, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.