Lung CancerNCT06503432
The Effects of Programmed Death-ligand 1 on Postoperative Pain for Lung Cancer Patients
An observational study of Lung Cancer and Postoperative Pain, run by Peking University People's Hospital at 1 site in China.
Trial summary
The concentration of plasma programmed death-ligand 1(PD-L1) for lung cancer patients before video-assisted thoracoscopic surgery is detected. According to the distribution of plasma concentration, patients are divided into high or low expression of PD-L1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer, Postoperative Pain
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2024to Mar 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent video-assisted thoracoscopic surgery for malignant lung disease.
Who may be able to join
- American Society of Anesthesiologists physical status I-IV (males and females).
- 18-80 years of age.
- Patients undergoing video-assisted thoracoscopic surgery for malignant lung disease.
Who cannot join
- History of opioid abuse.
- Known psychiatric disorders.
- Unexpected conversion to thoracotomy or transferred to intensive care unit for further treatment.
- Combined with other surgeries or sites.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100037
Yi Feng, MD
About this study
The concentration of plasma programmed death-ligand 1(PD-L1) for lung cancer patients before video-assisted thoracoscopic surgery is detected. According to the distribution of plasma concentration, patients are divided into high or low expression of PD-L1. Differences in acute and chronic postoperative pain are compared between two groups of patients. And effects of PD-L1 expresion on postoperative pain in lung cancer patients are explained.
Read the detailed description
Chronic pain after video-assisted thoracoscopic surgery (VATS) has been a major concern for lung cancer patients. The relationship between plasma programmed cell death ligand-1 (PD-L1) concentration and chronic pain in post-VATS is uncertain. This study aims to explore the effects of PD-L1 levels on chronic pain and provide proactive pain management regimen according to individual genetic differences.
The concentration of plasma PD-L1 for lung cancer patients before video-assisted thoracoscopic surgery is detected. According to the distribution of plasma concentration, patients are divided into high or low expression of PD-L1. Differences in acute and chronic postoperative pain are compared between two groups of patients. And effects of PD-L1 expresion on postoperative pain in lung cancer patients are explained.
- Conditions
- Lung Cancer, Postoperative Pain
- Medical subject headings
- Lung Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| high expression of programmed death-ligand 1 | According to the distribution of PD-L1 concentration levels in the plasma, participants were divided into two groups: high expression of PD-L1 (PD-L1(H)) and low expression of PD-L1 (PD-L1(L)). | |
| low expression of programmed death-ligand 1 | According to the distribution of PD-L1 concentration levels in the plasma, participants were divided into two groups: high expression of PD-L1 (PD-L1(H)) and low expression of PD-L1 (PD-L1(L)). |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of chronic pain after surgery
Patients were followed up by the Brief Pain Inventory questionnaire about the details of chronic pain.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start20 Jul 2024
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
- Investigators
- Xue Tian, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503432
- Sponsor's protocol ID
- 2020PHB252-01
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Programmed Death-ligand 1 on Postoperative Pain for Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT06503432
- Acronym / sponsor ID
- 2020PHB252-01
- Conditions
- Lung Cancer, Postoperative Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 16 Jul 2024 (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.
The concentration of plasma programmed death-ligand 1(PD-L1) for lung cancer patients before video-assisted thoracoscopic surgery is detected. According to the distribution of plasma concentration, patients are divided into high or low expression of PD-L1. Differences in acute and chronic postoperative pain are compared between two groups of patients. And effects of PD-L1 expresion on postoperative pain in lung cancer patients are explained.
Detailed description
Chronic pain after video-assisted thoracoscopic surgery (VATS) has been a major concern for lung cancer patients. The relationship between plasma programmed cell death ligand-1 (PD-L1) concentration and chronic pain in post-VATS is uncertain. This study aims to explore the effects of PD-L1 levels on chronic pain and provide proactive pain management regimen according to individual genetic differences.
The concentration of plasma PD-L1 for lung cancer patients before video-assisted thoracoscopic surgery is detected. According to the distribution of plasma concentration, patients are divided into high or low expression of PD-L1. Differences in acute and chronic postoperative pain are compared between two groups of patients. And effects of PD-L1 expresion on postoperative pain in lung cancer patients are explained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high expression of programmed death-ligand 1 | – | –According to the distribution of PD-L1 concentration levels in the plasma, participants were divided into two groups: high expression of PD-L1 (PD-L1(H)) and low expression of PD-L1 (PD-L1(L)). |
| low expression of programmed death-ligand 1 | – | –According to the distribution of PD-L1 concentration levels in the plasma, participants were divided into two groups: high expression of PD-L1 (PD-L1(H)) and low expression of PD-L1 (PD-L1(L)). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent video-assisted thoracoscopic surgery for malignant lung disease.
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical status I-IV (males and females).
- 18-80 years of age.
- Patients undergoing video-assisted thoracoscopic surgery for malignant lung disease.
Key exclusion criteria (4 listed)
- History of opioid abuse.
- Known psychiatric disorders.
- Unexpected conversion to thoracotomy or transferred to intensive care unit for further treatment.
- Combined with other surgeries or sites.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the incidence of chronic pain after surgery
Time frame: 3 months after surgery
Patients were followed up by the Brief Pain Inventory questionnaire about the details of chronic pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Xue Tian, MD principal investigator
Peking University People's Hospital
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 Lung Cancer and Postoperative Pain, 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xue Tian, MD (88325581, justine_troy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of chronic pain after surgery (time frame: 3 months after surgery). 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 19 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.