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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04287712
Other study ID # 2018PHB233-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 13, 2018
Est. completion date May 20, 2020

Study information

Verified date June 2020
Source Peking University People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

There are no reliable blood-based tests currently available for early-stage lung cancer diagnosis. We try to establish a highly accurate method for detecting early-stage lung cancer by combining machine learning with untargeted and targeted metabolomics .


Description:

All plasma lipids were first detected by untargeted metabolomics methods and 9 feature lipids of early-stage lung cancer were selected by support vector machine algorithm. Then, a targeted metabolomics method was developed to detect the 9 lipids quantitatively based on multiple reaction monitoring mode. Finally, a detection model was established based on the 9 lipids.


Recruitment information / eligibility

Status Completed
Enrollment 558
Est. completion date May 20, 2020
Est. primary completion date October 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. pulmonary nodules or opacity

2. plan to receive surgery

Exclusion Criteria:

1. history of other malignancies

2. received anti-cancer treatment (chemotherapy, radiotherapy, targeted therapy, etc.) before surgery

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Plasma lipids
Plasma lipids were detected by an Ultimate 3000 ultra-high-performance liquid chromatography (UHPLC) system coupled with Q-Exactive MS (Thermo Scientific) . Then a detection model was built based on plasma lipids using machine learning algorithm.

Locations

Country Name City State
China Peking University People's Hospital Beijing Beijing

Sponsors (4)

Lead Sponsor Collaborator
Peking University People's Hospital Beijing Haidian Hospital, Jiangsu Cancer Institute & Hospital, Peking University Health Science Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma Lipids A detection model based on 9 lipids were developed, including 3 lysophosphatidylcholines, 5 phosphatidylcholines, and a triglyceride. The 9 lipids were detected by targeted metabolomics by mass spectrometry. All samples were detected together after participants recruitment and sample collection. All samples were detected within 18 months from sample collection.
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