Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:44 AM
Study NCT ID:
NCT07477158
Status:
RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes and Quality Of Life After Minimally Invasive Segmentectomy Versus Lobectomy for Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-07', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative dyspnea', 'timeFrame': 'It will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.', 'description': 'The postoperative dyspnea score will be calculated from the 33-35 items of the EORTC QLQ-LC29 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 29) questionnaire and standardized to a 0-100 score. These items assess dyspnoea in three modalities: during rest, walking and climbing stairs in the preceding week. In each setting dyspnea is quantified from 1 (not at all short or breath) to 4 (very much short of breath), therefore a higher score indicates a higher level of dyspnea.'}], 'secondaryOutcomes': [{'measure': 'Quality-Adjusted Life Years (QALYs)', 'timeFrame': 'Data will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.', 'description': 'Quality-adjusted life years (QALYs) will be calculated by combining survival with health-related quality of life measured using the EuroQol 5-Dimension ( EQ-5D) Questionnaire questionnaire at predefined follow-up time points. Utility scores derived from EQ-5D responses will be used to estimate QALYs using the area-under-the-curve method over the study period. Utility scores typically range from values below 0 (health states considered worse than death) to 1 (perfect health), with higher scores indicating better health status.'}, {'measure': 'Physical Functioning', 'timeFrame': 'Data will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.', 'description': 'Physical functioning will be assessed using the Physical Functioning scale of the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) questionnaire. This scale is calculated from items 1-5, which assess limitations in strenuous activities, walking long and short distances, the need to stay in bed or a chair during the day, and the need for assistance with basic daily activities. Scores are linearly transformed to a 0-100 scale according to the EORTC scoring manual, with higher scores indicating better physical functioning (100 = best functioning, 0 = worst).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Segmentectomy', 'Lobectomy', 'NSCLC', 'Lung Cancer', 'PROM', 'QoL', 'HRQoL'], 'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The goal is to compare patient reported outcomes, such as dyspnea, physical functioning and quality of life, between minimally invasive segmentectomy and lobectomy for stage I NSCLC during the first year after surgery.\n\nThe main questions it aims to answer are:\n\n* Do patients with stage I NSCLC that undergo minimally invasive segmentectomy have less postoperative dyspnea than patients that undergo lobectomy?\n* Do patients with stage I NSCLC that undergo minimally invasive segmentectomy have more favorable postoperative health related quality of life (HRQoL) than patients that undergo lobectomy?\n* Do patients with stage I NSCLC that undergo VATS segmentectomy or lobectomy have more favorable postoperative health related quality of life (HRQoL) than patients that undergo RATS segmentectomy or lobectomy?\n\nParticipants already undergoing surgical intervention as part of their regular medical care for resectable lung cancer will answer quality of life questionnaires preoperatively, at 1, 3, 6, and 12 months after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing elective thoracic surgery at a tertiary referral hospital will be considered for inclusion. The study population will consist of patients scheduled for pulmonary resection for suspected or confirmed malignant lung disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clinical stage I NSCLC who undergo segmentectomy or lobectomy with VATS or RATS.\n\nExclusion Criteria:\n\n* Thoracic surgery in the previous year\n* Neoadyuvant treatment\n* Failure to complete preoperative questionnaires'}, 'identificationModule': {'nctId': 'NCT07477158', 'briefTitle': 'Clinical Outcomes and Quality Of Life After Minimally Invasive Segmentectomy Versus Lobectomy for Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal'}, 'officialTitle': 'Living After Lung Surgery: Clinical Outcomes and Quality Of Life After Minimally Invasive Segmentectomy Versus Lobectomy for Lung Cancer', 'orgStudyIdInfo': {'id': '073/26'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Segmentectomy', 'description': 'Patients with cI NSLSC that undergo minimally invasive segmentectomy'}, {'label': 'Lobectomy', 'description': 'Patients with cI NSLSC that undergo minimally invasive lobectomy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28034', 'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Sara Fra, MD', 'role': 'CONTACT', 'email': 'sarafrafernandez@gmail.com', 'phone': '0034913369102'}, {'name': 'Nicolás Moreno, PhD', 'role': 'CONTACT', 'email': 'nicolas.moreno.hrc@gmail.com', 'phone': '0034913368048'}], 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Sara Fra, MD', 'role': 'CONTACT', 'email': 'sarafrafernandez@gmail.com', 'phone': '0034913369102'}, {'name': 'Nicolás Moreno, MD, PhD', 'role': 'CONTACT', 'email': 'sarafrafernandez@gmail.com', 'phone': '0034913368048'}], 'overallOfficials': [{'name': 'Sara Fra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Ramón y Cajal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sara Fra Fernandez', 'investigatorAffiliation': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal'}}}}