Early-Stage Lung CancerELAIDNCT04287712
Detection of Lung Cancer by Plasma Lipids
An observational study of Early-Stage Lung Cancer, run by Peking University People's Hospital at 1 site in China.
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 . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Early-Stage Lung Cancer
- What is being tested?
- Plasma lipids
- How many people
- 558 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2018to 20 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- pulmonary nodules or opacity
- plan to receive surgery
Who cannot join
- history of other malignancies
- received anti-cancer treatment (chemotherapy, radiotherapy, targeted therapy, etc.) before surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Detection of Early-stage Lung Cancer Using Machine Learning and Plasma Metabolomics
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 .
Read the detailed 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.
- Conditions
- Early-Stage Lung Cancer
- Being tested
- Plasma lipids
- Keywords
- Early-Stage Lung Cancer, Plasma Metabolomics, Lipids, Machine Learning
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Plasma lipids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: All samples were detected together after participants recruitment and sample collection. All samples were detected within 18 months from sample collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start13 Dec 2018
- Primary completion31 Oct 2019
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-Stage Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Haidian Hospital, Jiangsu Cancer Institute & Hospital, Peking University Health Science Center
- Responsible party
- Principal investigator, Jun Wang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287712
- Sponsor's protocol ID
- 2018PHB233-01
- Acronym
- ELAID
- Status last verified
- Jun 2020
- First submitted
- 13 Feb 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Early-stage Lung Cancer Using Machine Learning and Plasma Metabolomics
- ClinicalTrials.gov ID
- NCT04287712
- Acronym / sponsor ID
- ELAID / 2018PHB233-01
- Conditions
- Early-Stage Lung Cancer
- Keywords
- Early-Stage Lung Cancer, Plasma Metabolomics, Lipids, Machine Learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 558 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Beijing Haidian Hospital, Jiangsu Cancer Institute & Hospital, Peking University Health Science Center
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants received surgery | – | Diagnostic Test: Plasma lipidsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- pulmonary nodules or opacity
- plan to receive surgery
Key exclusion criteria (2 listed)
- history of other malignancies
- received anti-cancer treatment (chemotherapy, radiotherapy, targeted therapy, etc.) before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma lipidsPlasma 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. | Diagnostic test | Participants received surgery |
Primary outcome
Plasma Lipids
Time frame: All samples were detected together after participants recruitment and sample collection. All samples were detected within 18 months from sample collection.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early-Stage Lung Cancer, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Lipids (time frame: All samples were detected together after participants recruitment and sample collection. All samples were detected within 18 months from sample collection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.