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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Nodules
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Bo WANG; Phone Number: +86-15920405979; Email: bo_wang@anchordx.com
• Study Contact Backup: Name: Wenhua LIANG, MD; Phone Number: +86-13710249454; Email: liangwh1987@163.com

Study Locations

• China
  • Beijing, China
    • Not yet recruiting
    • Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital
    • Principal Investigator: Zhaohui TONG, MD
  • Chengdu, China
    • Not yet recruiting
    • Department of Respiratory Medicine, West China Hospital of Sichuan University
    • Principal Investigator: Dan LIU, MD
  • Guangzhou, China
    • Recruiting
    • The First Affiliated Hospital of Guangzhou Medical University
    • Contact: Wenhua LIANG, MD; Email: liangwh1987@163.com
    • Principal Investigator: Nanshan ZHONG, MD
    • Sub-Investigator: Wenhua LIANG, MD
  • Jinan, China
    • Not yet recruiting
    • Department of Respiratory, QILU Hospital, Shandong University
    • Principal Investigator: Wei XIAO, MD
  • Shanghai, China
    • Not yet recruiting
    • Department of Pulmonary Medicine, Zhongshan Hospital, Fudan University
    • Principal Investigator: Xin Zhang, MD
  • Wuhan, China
    • Not yet recruiting
    • Department of Respiratory and Critical Care Medicine, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
    • Principal Investigator: Jianping ZHAO, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The transcriptome of benign versus malignant by using RNA sequencing. The cfDNA in blood samples collected from patients with pulmonary nodules.	3 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The biomarker changes in nasal epithelium and matching blood and tissue samples so as to validate molecular tests using nasal epithelium to predict lung cancer.	The biomarker change in nasal epithelium to predict lung cancer.	3 Years
The individual or combinations of clinical, molecular, and imaging features can reliably identify individuals with indeterminate lung nodules 5-30 mm who have lung cancer	The individual or combination of clinical, molecular, and imaging features can reliably identify individuals who have lung cancer	3 Years

Collaborators and Investigators

• Sponsor: AnchorDx Medical Co., Ltd.
• Collaborators: Shanghai Zhongshan Hospital; West China Hospital; Tongji Hospital; Qilu Hospital of Shandong University; Beijing Chao Yang Hospital; The First Affiliated Hospital of Guangzhou Medical University; Johnson & Johnson (China) Investment Ltd.
• Investigators: Study Chair: Nanshan ZHONG, MD, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: July 5, 2020
• First Submitted That Met QC Criteria: July 5, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Lung Cancer; Computed Tomography (CT); Noninvasive Biomarkers; Nasal epithelium
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: AnchorDx LC023

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