NCT04287712

Brief 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
558

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

11 months

First QC Date

February 13, 2020

Last Update Submit

June 2, 2020

Conditions

Keywords

Early-Stage Lung CancerPlasma MetabolomicsLipidsMachine Learning

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Participants received surgery

Patients who underwent surgery at the Department of Thoracic Surgery of Peaking University People's Hospital, Jiangsu Cancer Hospital, and Beijing Haidian Hospital were enrolled with the following criteria: 1) pathologically confirmed lung cancer; 2) no history of other malignancies; 3) no anti-cancer treatment (chemotherapy, radiotherapy, targeted therapy, etc.) before surgery. Plasma samples were collected before surgery and plasma lipids were detected by mass spectrometry. Pathological diagnosis and clinical characteristics of enrolled participants were retrieved.

Diagnostic Test: Plasma lipids

Interventions

Plasma lipidsDIAGNOSTIC_TEST

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.

Participants received surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who with pulmonary nodules or opacity and underwent surgery at the Department of Thoracic Surgery of Peaking University People's Hospital, Jiangsu Cancer Hospital, and Beijing Haidian Hospital were enrolled

You may qualify if:

  • pulmonary nodules or opacity
  • plan to receive surgery

You may not qualify if:

  • history of other malignancies
  • received anti-cancer treatment (chemotherapy, radiotherapy, targeted therapy, etc.) before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

For enrolled participants, 4 ml of peripheral blood were collected in tubes containing EDTA and all participants had fasted at least 8 hr before blood collection. Whole blood was centrifuged at 1600 g for 10 min followed by centrifugation at 16000 g for 10 min. Plasma aliquots were transferred into cryovials and stored at -80 °C.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

February 13, 2020

First Posted

February 27, 2020

Study Start

December 13, 2018

Primary Completion

October 31, 2019

Study Completion

May 20, 2020

Last Updated

June 4, 2020

Record last verified: 2020-06

Locations