Plasma Proteomic Biomarkers for Early Diagnosis of Lung Cancer

NCT05742204 | Active Not Recruiting

• 1 other identifier: 2022-1109
• Study Type: observational
• Target: 3,700
• Locations: 1 country
• Sites: 1

Brief Summary

We will identify plasma proteomics biomarkers for early diagnosis of lung cancer.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Plasma proteomic biomarkers

  Plasma proteomic biomarkers for detection of lung cancer

  1 month after surgery

• Model or classifier performance

  Artificial intelligent (AI) assisted proteomics classifier will be developed for early diagnosis of lung cancer; and model or classifier performance including AUC, sensitivity, specificity, and accuracy

  1 month after surgery

Study Arms (2)

Lung cancer group

Patients age over 18, with confirmed diagnosis of lung cancer.

Other: Plasma protein biomarker analysis

Control group

Non-cancer patients including healthy volunteers, chronic inflammatory airway diseases such as chronic obstructive airway disease, asthma, and bronchiectasis, etc.

Other: Plasma protein biomarker analysis

Interventions

Plasma protein biomarker analysis OTHER

Plasma samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment.We will use TMT-based proteomics approaches to analyze more than 2000 proteins in plasma samples from lung cancer patients .

Lung cancer group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study group: Patients with suspected or confirmed diagnosis of lung cancer. Control group: Non-cancer subjects including healthy volunteers, chronic inflammatory airway diseases such as chronic obstructive airway disease, asthma, and bronchiectasis, etc.

You may qualify if:

• CT screening results showed that the size of pulmonary nodules was more than 5mm
• No treatment related to pulmonary nodules/lung cancer (including surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, etc.)
• Complete clinical and imaging data
• Chest CT/ low-dose spiral CT reports can be provided in the last 3 months
• Voluntarily sign informed consent

You may not qualify if:

• There is a history of tumor
• Clinically uncontrolled active infections, such as acute pneumonia, tuberculosis, etc.
• Received any treatment related to pulmonary nodules, such as antibiotics and hormones, in the past 4 weeks
• Complicated with other tumors and serious diseases of the heart, liver, kidney, brain, blood and other systems
• Participated in other clinical trials within the last 3 months
• Combined with liver and kidney insufficiency, hypoproteinemia and other diseases affecting protein content
• You are pregnant or breastfeeding

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China, 310009, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Weilin Wang

  2nd Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: February 23, 2023
• Study Start: February 1, 2023
• Primary Completion: May 1, 2025
• Study Completion (Estimated): October 31, 2032
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

CN (1)