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NCT Number: NCT05742204

Plasma Proteomic Biomarkers for Early Diagnosis of Lung Cancer

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China, 310009

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 .

Primary outcomes

  1. Plasma proteomic biomarkers

    Time frame: 1 month after surgery

    Plasma proteomic biomarkers for detection of lung cancer

  2. Model or classifier performance

    Time frame: 1 month after surgery

    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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2032
First posted
Feb 23, 2023
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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