Plasma Proteomic Biomarkers for Early Diagnosis of Lung Cancer

Lung Cancer Clinical Trial

Official title:

Identification and Functional Verification Study in Plasma Proteomic Biomarkers for Early Diagnosis of Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05742204
• Other study ID #: 2022-1109
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: October 31, 2032

Study information

• Verified date: February 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Ming Wu, M.D
• Phone: +8613757118715
• Email: iwuming22[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

We will use TMT-based proteomics approaches to analyze more than 2000 proteins in plasma samples from lung cancer patients and controls. Artificial intelligent (AI) assisted proteomics classifier will be developed for early diagnosis of lung cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3700
• Est. completion date: October 31, 2032
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Plasma protein biomarker analysis
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 .
• Plasma protein biomarker analysis
Plasma samples of control subjects were collected.

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma proteomic biomarkers	Plasma proteomic biomarkers for detection of lung cancer	1 month after surgery
Primary	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