Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-03 @ 7:53 PM
Study NCT ID:
NCT06503432
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Programmed Death-ligand 1 on Postoperative Pain for Lung Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-10', 'studyFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2024-07-09', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of chronic pain after surgery', 'timeFrame': '3 months after surgery', 'description': 'Patients were followed up by the Brief Pain Inventory questionnaire about the details of chronic pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients underwent video-assisted thoracoscopic surgery for malignant lung disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. American Society of Anesthesiologists physical status I-IV (males and females).\n2. 18-80 years of age.\n3. Patients undergoing video-assisted thoracoscopic surgery for malignant lung disease.\n\nExclusion Criteria:\n\n1. History of opioid abuse.\n2. Known psychiatric disorders.\n3. Unexpected conversion to thoracotomy or transferred to intensive care unit for further treatment.\n4. Combined with other surgeries or sites.'}, 'identificationModule': {'nctId': 'NCT06503432', 'briefTitle': 'The Effects of Programmed Death-ligand 1 on Postoperative Pain for Lung Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'The Effects of Programmed Death-ligand 1 on Postoperative Pain for Lung Cancer Patients', 'orgStudyIdInfo': {'id': '2020PHB252-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'high expression of programmed death-ligand 1', 'description': '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)).'}, {'label': 'low expression of programmed death-ligand 1', 'description': '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)).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Feng, MD', 'role': 'CONTACT'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xue Tian, MD', 'role': 'CONTACT', 'email': 'justine_troy@163.com', 'phone': '88325581'}], 'overallOfficials': [{'name': 'Xue Tian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director of department of Anesthesiology and Pain medicine', 'investigatorFullName': 'Yi Feng, MD', 'investigatorAffiliation': "Peking University People's Hospital"}}}}