Plasma Proteomic Biomarkers for Early Diagnosis of Lung Cancer

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05742204

Collaborator

(none)

3,700

Enrollment

Location

117

Anticipated Duration (Months)

31.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Other: Plasma protein biomarker analysis Other: Plasma protein biomarker analysis

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

3700 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Oct 31, 2032

Arms and Interventions

Arm	Intervention/Treatment
Lung cancer group Patients age over 18, with confirmed diagnosis of lung cancer.	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 .
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 Plasma samples of control subjects were collected.

Arm

Intervention/Treatment

Lung cancer group

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

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 .

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

Plasma samples of control subjects were collected.

Outcome Measures

Primary Outcome Measures

Plasma proteomic biomarkers [1 month after surgery]
Plasma proteomic biomarkers for detection of lung cancer
Model or classifier performance [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou		China	310009

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Study Chair: Weilin Wang, 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT05742204

Other Study ID Numbers:

2022-1109

First Posted:

Feb 23, 2023

Last Update Posted:

Feb 27, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Study Results

No Results Posted as of Feb 27, 2023