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A Prospective Cohort Study of Chinese Patients With Pulmonary Nodules: Prediction of Lung Cancer Using Noninvasive Biomarkers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04462185
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
Sponsor:
Collaborators:
The First Affiliated Hospital of Guangzhou Medical University
Tongji Hospital
Qilu Hospital of Shandong University
Shanghai Zhongshan Hospital
West China Hospital
Beijing Chao Yang Hospital
Johnson & Johnson (China) Investment Ltd.
Information provided by (Responsible Party):
AnchorDx Medical Co., Ltd.

Brief Summary:

The broad goals of this study is to identify changes in genomic landscape during transition from stage 0 to stage 1 lung cancer.

This study intends to determine whether diagnostic biomarkers measured in minimally invasive biospecimens are able to correlate molecular, clinical and imaging features to distinguish malignant from benign pulmonary nodules. The diagnostic markers once validated can be used as broad screening tools for lung cancer.


Condition or disease Intervention/treatment
Pulmonary Nodules Diagnostic Test: A genomic and transcriptomic landscape analysis

Detailed Description:

The four-year study aims to recruit 3000 patients (1500 GGO and 1500 solid / semi solid nodules) in the study based on qualifying for a lung cancer screening CT or by routine CT chest with the observation of a lung nodule between 5-30mm diameter. These patients will be followed for 2~3 years and be managed according to institutional standard of care. This may involve the Chinese Thoracic Society guideline or Fleischner criteria (either 2013 or 2017 guidelines). The clinical data, CT imaging and biospecimens will be collected during each visit. Once a patient undergoes surgery, tissue samples (FFPE) from surgery will also be collected.

The gold standard for lung cancer diagnosis will be the results of bronchoscopic biopsy of lung or lymph nodes, percutaneous biopsy of lung or other organ sites, surgical biopsy or resection, or a minimum follow-up of 2 years.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study of Chinese Patients With Pulmonary Nodules: Prediction of Lung Cancer Using Noninvasive Biomarkers
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Prospective Cohort
This is a prospectively enrolling cohort study and 3000 patients (1500 GGO and 1500 solid / semi solid nodules) with radiologic diagnosis of indeterminate pulmonary nodule (5-30 mm) will be recruited. All participants will be followed up with chest CT or low-dose computed tomography (LDCT) scans for 2-3 years, and take the diagnostic test, a genomic and transcriptomic landscape analysis, at each visit.
Diagnostic Test: A genomic and transcriptomic landscape analysis
A genomic and transcriptomic landscape analysis will be developed to identify and characterize the transcriptome of benign versus malignant by using RNA sequencing, and to profile cfDNA in blood samples collected from patients with pulmonary nodules.




Primary Outcome Measures :
  1. To identify the changes in genomic landscape related to progression from Stage 0 to Stage I lung cancer that could be utilized for early lung cancer diagnosis and intervention. [ Time Frame: 3 Years ]

    To identify and characterize the transcriptome of benign versus malignant by using RNA sequencing.

    To profile cfDNA in blood samples collected from patients with pulmonary nodules.



Secondary Outcome Measures :
  1. To compare and correlate biomarker changes in nasal epithelium and matching blood and tissue samples so as to validate molecular tests using nasal epithelium to predict lung cancer. [ Time Frame: 3 Years ]
  2. To determine if individual or combinations of clinical, molecular, and imaging features can reliably identify individuals with indeterminate lung nodules 5-30 mm who have lung cancer [ Time Frame: 3 Years ]

Biospecimen Retention:   Samples With DNA
Whole blood; Nasal epithelium; Biopsy / surgical specimen


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects with pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans between 5-30 mm diameter
Criteria

Inclusion Criteria:

  • 18 Years and older, both male and female
  • Willing and able to provide a written informed consent
  • Radiologic diagnosis of solid indeterminate pulmonary nodule (5-30 mm) OR semi-solid (mixed density) nodule with solid component of at least 5mm OR non-solid nodule (including pGGO); must be of appropriate size at enrollment, but nodule(s) may have been first identified within 12 months prior. Furthermore, nodule(s) < 5 mm in size may have been first identified greater than 12 months prior to enrollment though it must grow into the appropriate size range (5-30 mm) within 12 months prior to enrollment. If multiple nodules were diagnosed, choose the most representative one with the longest diameter as the target lesion; if two or more nodules are of the same largest size, choose the one with the perpendicular longest diameter
  • CT scan completed within 3 months prior to enrollment
  • Agree to tolerate all biospecimen collection as required by protocol
  • Agree to comply with standard of care follow up visits including clinical exams, diagnostic work-ups, and imaging for 2~3 years from enrollment
  • Agree to fill out Patient Lung History Questionnaire

Exclusion Criteria:

  • History or previous diagnosis of primary lung cancer, metastatic lung cancer, or any other non-lung cancer within 5 years (exceptions are adequately treated squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast)
  • Any receipt of cytotoxic agents within the past 6 months
  • Any symptoms of lung cancer (unexplained weight loss, recent hemoptysis)
  • Pregnant or lactating women
  • Underwent invasive biopsy procedures (e.g. bronchoscopies or CT-guided transthoracic biopsies) before enrollment
  • Receipt of transfusion within 30 days prior to enrollment
  • Fail to understand or provide a written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04462185


Contacts
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Contact: Bo WANG +86-15920405979 bo_wang@anchordx.com
Contact: Wenhua LIANG, MD +86-13710249454 liangwh1987@163.com

Locations
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China
Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital Not yet recruiting
Beijing, China
Principal Investigator: Zhaohui TONG, MD         
Department of Respiratory Medicine, West China Hospital of Sichuan University Not yet recruiting
Chengdu, China
Principal Investigator: Dan LIU, MD         
The First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, China
Contact: Wenhua LIANG, MD       liangwh1987@163.com   
Principal Investigator: Nanshan ZHONG, MD         
Sub-Investigator: Wenhua LIANG, MD         
Department of Respiratory, Qilu Hospital, Shandong University Not yet recruiting
Jinan, China
Principal Investigator: Wei XIAO, MD         
Department of Pulmonary Medicine, Zhongshan Hospital, Fudan University Not yet recruiting
Shanghai, China
Principal Investigator: Xin ZHANG, MD         
Department of Respiratory and Critical Care Medicine, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Not yet recruiting
Wuhan, China
Principal Investigator: Jianping ZHAO, MD         
Sponsors and Collaborators
AnchorDx Medical Co., Ltd.
The First Affiliated Hospital of Guangzhou Medical University
Tongji Hospital
Qilu Hospital of Shandong University
Shanghai Zhongshan Hospital
West China Hospital
Beijing Chao Yang Hospital
Johnson & Johnson (China) Investment Ltd.
Investigators
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Study Chair: Nanshan ZHONG, MD The First Affiliated Hospital of Guangzhou Medical University
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Responsible Party: AnchorDx Medical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04462185    
Other Study ID Numbers: AnchorDx LC023
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AnchorDx Medical Co., Ltd.:
Noninvasive Biomarkers
Lung Cancer
Computed Tomography (CT)
Nasal epithelium
Additional relevant MeSH terms:
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Lung Neoplasms
Multiple Pulmonary Nodules
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases