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

NCT04462185 | Unknown

• 1 other identifier: AnchorDx LC023
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 6

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.

Conditions

Pulmonary Nodules

Keywords

Noninvasive Biomarkers; Lung Cancer; Computed Tomography (CT); Nasal epithelium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

  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

  3 Years

Study Arms (1)

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

Interventions

A genomic and transcriptomic landscape analysis DIAGNOSTIC_TEST

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.

Prospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AnchorDx Medical Co., Ltd.: lead
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Tongji Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Shanghai Zhongshan Hospital: collaborator
• West China Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator
• Johnson & Johnson (China) Investment Ltd.: collaborator

Study Sites (6)

Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital

Beijing, China

NOT YET RECRUITING

Department of Respiratory Medicine, West China Hospital of Sichuan University

Chengdu, China

NOT YET RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

RECRUITING

Department of Respiratory, Qilu Hospital, Shandong University

Jinan, China

NOT YET RECRUITING

Department of Pulmonary Medicine, Zhongshan Hospital, Fudan University

Shanghai, China

NOT YET RECRUITING

Department of Respiratory and Critical Care Medicine, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood; Nasal epithelium; Biopsy / surgical specimen

MeSH Terms

Conditions

Multiple Pulmonary Nodules; Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nanshan ZHONG, MD

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Bo WANG

CONTACT

+86-15920405979; bo_wang@anchordx.com

Wenhua LIANG, MD

CONTACT

+86-13710249454; liangwh1987@163.com

Study Design

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

Study Record Dates

• First Submitted: July 5, 2020
• First Posted: July 8, 2020
• Study Start: July 1, 2020
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)