Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-01-02 @ 9:24 AM
Study NCT ID:
NCT07131293
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
European Registry Study on Lymphatic Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D011504', 'term': 'Protein-Losing Enteropathies'}, {'id': 'D002916', 'term': 'Chylothorax'}, {'id': 'D044148', 'term': 'Lymphatic Abnormalities'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2025-07-29', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Symptoms Following Lymphatic Intervention, assessed by:', 'timeFrame': 'From time of treatment to yearly follow-up up to 5 years.', 'description': 'Patient-reported or physician-assessed symptoms (e.g., cough, diarrhea, dyspnea) will be categorized as normalized, improved, unchanged, or worsened compared to baseline.\n\nUnit of Measure:\n\nSymptom status category (normalized / improved / unchanged / worsened)'}, {'measure': 'Change in Objective Biomarkers Following Lymphatic Intervention', 'timeFrame': 'From time of treatment to yearly follow-up up to 5 years.', 'description': 'Objective clinical findings (e.g., serum albumin level, lymphocyte count, fluid accumulation) will be categorized as normalized, improved, unchanged, or worsened compared to baseline.\n\nUnit of Measure:\n\nBiomarker status category (normalized / improved / unchanged / worsened)'}, {'measure': 'Composite improvement:', 'timeFrame': 'From time of treatment to yearly follow-up up to 5 years.', 'description': '≥50% reduction in presenting symptoms and/or ≥20% improvement in key biomarkers (e.g., serum albumin, lymphocyte count etc.).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymphatic complications', 'Multicenter study', 'Plastic bronchitis', 'Protein Losing Enteropathy', 'Chylothorax'], 'conditions': ['Lymphatic Disorders', 'Plastic Bronchitis', 'Protein Losing Enteropathy', 'Chylothorax', 'Lymphatic Abnormalities']}, 'descriptionModule': {'briefSummary': 'This European multicenter observational study aims to evaluate the real-world use, timing, and outcomes of lymphatic interventions in patients with congenital heart disease and/or primary lymphatic disorders. The study will examine the effectiveness of diagnostic imaging and interventional techniques, such as lymphatic embolization, in improving clinical symptoms, biomarkers, and fluid-related complications. The central question is whether early diagnosis and targeted intervention can lead to clinically meaningful improvements and reduced need for reintervention. Data collected retrospectively and prospectively from participating centers will help identify predictors of outcome, assess disease severity, and inform standardized diagnostic and therapeutic pathways across Europe.', 'detailedDescription': 'This is a prospective, multicenter observational study with retrospective components. The study population includes patients who have undergone or are undergoing lymphatic imaging diagnostics and lymphatic interventions at participating centers across Europe. Patients are included both retrospectively (from medical records) and prospectively as part of their routine clinical care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be identified from pediatric and adult congenital cardiology and lymphatic referral centers across Europe. The study population includes patients of any age with congenital heart disease (CHD) and associated central lymphatic complications (such as plastic bronchitis, protein-losing enteropathy, or chylothorax), as well as patients with primary central lymphatic disorders. Patients are included from tertiary care institutions that perform lymphatic imaging and/or interventions and will be enrolled retrospectively from existing clinical records and prospectively during routine care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of any age with a confirmed central lymphatic disorder, either in the context of CHD or as a primary lymphatic disorder, diagnosed by lymphatic imaging (e.g., T2-weighted MRL, DCMRL, or percutaneous lymphangiography under fluoroscopy).\n* Patients who have undergone, or are undergoing, diagnostic lymphatic imaging and/or interventional procedures for their lymphatic disorder.\n* Patients who are receiving, or have received, conservative (non-interventional) management for their lymphatic disorder.\n\nExclusion Criteria:\n\n* Patients with isolated peripheral lymphatic disorders not involving the central lymphatic system.\n* Patients with acute postoperative iatrogenic chylothorax (\\<3-4 weeks duration and not requiring intervention).\n* Patients without sufficient clinical documentation to confirm diagnosis, treatment, or follow-up.\n* Patients who decline, or whose legal guardians decline, to provide informed consent (for prospective inclusion).'}, 'identificationModule': {'nctId': 'NCT07131293', 'acronym': 'EURO-LYMPH', 'briefTitle': 'European Registry Study on Lymphatic Interventions', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'European Registry Study on Lymphatic Interventions: Towards Standardized Care in CHD-Related Lymphatic Disorders', 'orgStudyIdInfo': {'id': 'R-25051744'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lymph intervention', 'interventionNames': ['Procedure: Lymphatic intervention']}], 'interventions': [{'name': 'Lymphatic intervention', 'type': 'PROCEDURE', 'description': 'This intervention was made as part of their clinical treatment.', 'armGroupLabels': ['Lymph intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Sanam Safi-Rasmussen, MD', 'role': 'CONTACT', 'email': 'sanam.safi-rasmussen@regionh.dk', 'phone': '+45 3049 0641'}, {'name': 'Vibeke Hjortdal, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rigshospitalet, Copenhagen University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Sanam Safi-Rasmussen, MD', 'role': 'CONTACT', 'email': 'sanam.safi-rasmussen@regionh.dk', 'phone': '+4530490641'}], 'overallOfficials': [{'name': 'Vibeke E Hjortdal, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sanam Safi-Rasmussen, MD & PhD-fellow', 'investigatorFullName': 'Sanam Safi-Rasmussen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}