The Effects of Programmed Death-ligand 1 on Postoperative... | NCT06503432

Studies
The Effects of Programmed Death-ligand 1 on Postoperative Pain for Lung Cancer Patients

NCT06503432

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Sep 19, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Lung Cancer
Postoperative Pain

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2024Actual

Primary Completion Date

Feb 2025Estimated

Completion Date

Mar 2025Estimated

First Submitted Date

Jun 26, 2024

First Submission Date that Met QC Criteria

Jul 9, 2024

First Posted Date

Jul 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2024

Last Update Posted Date

Sep 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yi Feng, MD, director of department of Anesthesiology and Pain medicine, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)).

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the incidence of chronic pain after surgery	Patients were followed up by the Brief Pain Inventory questionnaire about the details of chronic pain.	3 months after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients underwent video-assisted thoracoscopic surgery for malignant lung disease.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xue Tian, MD	Contact	88325581		justine_troy@163.com

Overall Officials

Name	Affiliation	Role
Xue Tian, MD	Peking University People's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University People's Hospital	Recruiting	Beijing	Beijing Municipality	100037	China

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided