Lopende studies in AZ Sint-Lucas

Anesthesie

Studieteam

• Dr. Freekje Viaene

Lopende studies

• UTTX: Uterustransplantatie vanuit de multi-orgaandonor: een prospectieve studie - donatieluik.

Endocrinologie

Studieteam

• Dr. Inge Van Boxelaer

Lopende studies

• CORDELIA: Continuous glucose monitoring for women with gestational diabetes: a randomized controlled trial.

Fertiliteit

Studieteam

• Dr. Nele Van Renterghem

Lopende studies

• HYFOIL: Live birth after additional tubal flushing with oil-based contrast versus no additional flushing: a randomised, multicentre, parallel group pragmatic trial in infertile women with at least one patent tube at Hysterosalpingo-foam sonography.

Gynaecologie

Studieteam

• Dr. Victoria Bracke
• Dr. Rawand Salihi

Lopende studies

• Elevate: Early dEtection of cerVical cAncer in hard-to-reach populations of women through portable and point-of-care HPV Testing.
• B.OSS B.OSS: Belgian Obstetric Surveillance System.
• VULVA: Gegevensverzameling van vrouwen die gediagnosticeerd zijn met vulvacarcinoom (VULVA).

Hart-en vaatziekten

De dienst hart- en vaatziekten neemt intensief deel aan internationale wetenschappelijke fase 2b en fase 3 studies waardoor patiënten de kans krijgen deel te nemen aan onderzoek met nieuwe, veelbelovende medicatie voor specifieke hart- en vaataandoeningen. Specifiek opgeleide studieverpleegkundigen zorgen voor de opvolging, samen met de arts.

Studieteam

• Dr. Hermans Kurt
• Dr. Vandekerckhove Hans
• Dr. Katarina van Beeumen

Lopende studies

• ACO-Real: A non-interventional study providing insights into the use of Acoramidis in Patients with ATTR Amyloidosis with Cardiomyopathy (ATTR-CM) in routine clinical practice
• BE.REAL: A Belgian Registry to Evaluate the reAl life treatment with incLisiran on top of standard of care lipid-lowering therapy in patients with atherosclerotic cardiovascular disease: the Belgian REAL (BE.REAL) registry.
• BI_1378-0020 A Phase III: double-blind, randomised, parallel-group superiority trial to evaluate efficacy & safety of the combined use of oral BI 690517 & empagliflozin compared with placebo & empagliflozin in participants with symptomatic heart failure & LVEF >40%.
• COL BE PCI: Colchicine in Belgium in patients with coronary artery disease after percutaneous coronary intervention.
• Easi HF Reduced 1378-0018: A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral vicadrostat (BI 690517) and empagliflozin compared with placebo and empagliflozin in participants with symptomatic chronic heart failure (HF: NYHA II-IV) and left ventricular ejection fraction (LVEF) < 40%
• EHRA-PATHS WP5 EHRA-PATHS: Addressing multimorbidity in elderly atrial fibrillation patients through interdisciplinary, patient-centred systematic care pathways Clinical and health economic evaluation of new care pathways.
• Maritime-CV study, AMG -133-20220196: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants with Atherosclerotic Cardiovascular Disease and Overweight or Obesity
• Ocean(a): A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Patients with Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein (a).
• SCAD REGISTRY: A registry of Spontaneous Coronary Arterial Dissection.
• SOS-AMI: Selatogrel Outcome Study in suspected Acute Myocardial Infarction (SOS-AMI).
• Triconos Study, DSE-BMP-01-24-EU: Effectiveness and Safety of Bempedoic Acid in combination with Ezetimibe and either Rosuvastatin or Atorvastatin in Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia: an Observational Study
• Victorian-2-Prevent: A randomized, double-blind, placebo-controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease.

Heelkunde

Studieteam

• Dr. Kjell Fierens
• Dr. Elodie Melsens

Lopende studies

• BEET-IT: Use of beetroot juice to protect against postoperative ileus following colorectal surgery
  
• M2R2: M2R2 Collaborative. Multicenter Ventral Mesh Rectopexy Registry

Huidziekten

De dienst huidziekten neemt actief deel aan klinische studies die de behandelingsmogelijkheden voor allerhande huidaandoeningen evalueren zoals psoriasis, eczeem en huidkanker. Zo blijft de dienst op de hoogte van de meest recente ontwikkelingen en garanderen ze de beste behandeling voor de patiënt.

Studieteam

• Dr. Chevolet Ines
• Dr. Dierckxsens Laurence
• Dr. Heughebaert Carol
• Dr. Kint Bernard
• Dr. Lissens Esther
• Dr. Pescod Stefanie

Lopende studies

• INCB018424-316 TRuE-AD5: Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Children and Adolescents (6 to < 18 Years Old) With Moderate Atopic Dermatitis
• INCB018424-325 TRuE-HS: A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa

Kinderziekten

Studieteam

• Dr. Sarah De Schryver

Lopende studies

• DBPCFC - SPT - C: Dubbelblinde placebogecontroleerde voedingsallergietesten in de praktijk: uitwerking van een breed kader voor de uitvoering ervan - Proof of concept testvoedingen via huidpriktesten bij kinderen.
• EPI-ROTA-067 BOD BE DB: An observational study to assess the trends in confirmed rotavirus gastroenteritis (RV GE) hospitalisations and to assess the impact of the switch from current to Porcine circovirus (PCV)-free GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus vaccine, in children aged <2 years, in Belgium.

Laboratorium

Studieteam

• Dr. Jos Van Acker
• Dr.Anne-Marie Van den Abeele

Lopende studies

• HDV Epidemiology of Hepatitis Delta Virus in Belgium: a prospective cross-sectional cohort study.
• NAC: National Antibiogram Comittee.

Longziekten

Studieteam

• Dr. Filip Triest

Lopende studies

• Ozawade: refractaire hypersomnolentie bij OSAS onder CPAP therapie.
• Predictumab: Predictive factors and magnitude of response to Omalizumab and Mepolizumab in allergic and eosinophilic severe asthma, an open-label, controlled, randomized multinational pragmatic trial.

Maag-, darm- en leverziekten

De dienst maag-, darm- en leverziekten werkt actief mee aan klinische studies rond IBD. Inflammatoire darmziekten (=IBD), zoals de ziekte van Crohn en Colitis Ulcerosa, zijn tot op heden nog niet te genezen. Deze aandoeningen hebben een grote invloed op de kwaliteit van leven van de patiënt. Daarom is het van groot belang om door middel van wetenschappelijk onderzoek de verschillende bestaande behandelingen te optimaliseren, nieuwe behandelingsmogelijkheden te onderzoeken en de veiligheid van de behandelingen op lange termijn te bestuderen. Als patiënt word je tijdens deze studies heel nauw opgevolgd om elk effect van de behandeling te kunnen opsporen.

Naast de IBD-studies werkt deze dienst ook mee aan studies rond tumoren van het spijsverteringsstelsel en infecties (Clostridium difficile).

Studieteam

• Dr. De Clerck Frederik
• Prof. Dr. Peeters Harald
• Dr. Rogge Sofie
• Dr. Strubbe Beatrijs
• Dr. Van Ongeval Johan

Lopende studies

• AMARETTO: Subcutaneous infliximab after a previous intravenous dose optimization.
• A Real-world Study to Evaluate Clinical Outcomes of dostarlimab in Patients with Previously Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer (firma GSK)
• BALLAD: Ballad Blegium: a trial to evaluate the potential benefit of adjuvant chemotherapy for small bowel adenocarcinoma.
• C6461003: An Interventional, Phase 3, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of PF-08634404 in Combination with Chemotherapy Versus Bevacizumab in Combination with Chemotherapy in Treatment-Naïve Participants with Metastatic Colorectal Cancer
• DNET: An epidemiological and medical data collection of patients suffering from digestive neuroendocrine tumors via an electronic registry
• GALOCEAN: A prospective, non-interventional, multi-country cohort study of the effectiveness and safety of filgotinib in adult patients with moderately to severely active ulcerative colitis.
• HeliResC: Accuraatheid van de detectie van Helicobacter pylori en clarithromycine resistentie in stoelgang in vergelijking met maagbiopt
• HYRISS HYRISS: A multicenter, international, prospective, non-interventional, observational study, to assess treatment retention of an adalimumab biosimilar (Hyrimoz®) in IBD patients in real life setting.
• ICONIC-UC: A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults with an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis
• ICONIC-CD: A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn’s Disease
• Omicrohn: Active RandoMIsed Study of Treatment Selection Based on Epigenetic Markers Versus Standard of Care Treatment Selection in Adults With CROHN’s Disease: OMICROHN.
• ON-TRK: Prospective non-interventional study in patients with locally advanced or metastatic TRK fusion cancer treated with larotrectinib.
• PASSPORT: Prospective cohort study of functional dyspepsia/postprandial distress syndrome patients treated with Itopride
• PERFORMANCE: Prediction of surgical resectability after folfirinox chemotherapy for borderline resectable and locally advanced pancreatic cancer: the role of diffusion weighted magnetic resonance imaging, radiomics and liquid biopsy
• SIBERITE: A phase III, multicenter, double-blind, placebo-controlled, treat-through study to assess the efficacy and safety of induction and maintenance therapy with RO7790121 in patients with moderately to severely active crohn’s disease
• SKYLINE-UC: Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis
• Soprano CD: Prevention of postoperative endoscopic recurrence with endoscopy-driven versus systematic biological therapy: a randomized, multicentre, parallel group pragmatic non-inferiority trial in adult patients with Crohn’s disease undergoing an ileocolonic resection with ileocolonic anastomosis.

Neus-, keel- en oorziekten

Studieteam

• Dr. Stefan Delreu
• Dr. Philippe Leune

Lopende studies

• Nasumab II: Real life study assessing long term outcomes and predictive factors of response to biologicals in patients with severe Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) with or without comorbid asthma.
• Effect of outpatient vestibular revalidation in patients with unilateral vestibular hypofunction: retrospective analysis.

Neurochirurgie

Studieteam

• Dr. Kristel Vanchaze

Lopende studies

• FOOT DROP: a prospective, multi-center, randomized, parallel-group controlled trial to compare conservative versus surgical treatment of foot drop in peroneal nerve entrapment – Foot Drop.

Neurologie

Het neurologisch studiecentrum neemt deel aan klinische studies die nieuw ontwikkelde behandelingsmogelijkheden evalueren op effectiviteit en efficiëntie. Deze studies zijn actueel, vooral gericht op eerder zeldzame neuromusculaire aandoeningen zoals ALS, myasthenia gravis en myositis.

Studieteam

• Prof. dr. De Bleecker Jan
• Dr. Loret Griet
• Dr. Pieter Olivier

Lopende studies

• ABCURO2/ABC008-IBM-202: An Open-label, Multicenter Study to Evaluate the Long-term Safety and Efficacy of Ulviprubart (ABC008) in Subjects Who Have Completed a Trial of Ulviprubart for the Treatment of Inclusion Body Myositis.
• ADAPT SERON/ARGX-113-2308: A randomized, double-blinded, placebo-controlled, Phase 3, Parallel-group design study evaluating the efficacy and safety of Efgartigimod IV in adult participants with acethylcholine receptor binding antibody seronegative generalized myasthenia gravis.
• ARDA+/ARGX-117-2003: A Long-term Extension of the ARGX-117-2002 Trial to Evaluate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy
• ALKIVIA+/ARGX-113-2011: A Phase 3, Single-Arm, Multicenter, Open-label Extension of Study ARGX-113-2007 to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy.
• DBS RETRO: Deep Brain Stimulation (DBS) Retrospective Outcomes Study.
• Essential Tremor Registry: Boston Scientific Registry of Deep Brain Stimulations for treatment of Essential Tremor (ET).
• NIMBLE/R3918-MG-2018: Werkzaamheid en veiligheid van de combinatiebehandeling met pozelimab en cemdisiran bij patiënten met symptomatische gegeneraliseerde myasthenia gravis.
• VIVACITY-MG3/MOM-M281-011: Een gerandomiseerd, dubbelblind, placebogecontroleerd fase 3-onderzoek in meerdere centra ter beoordeling van de werkzaamheid, veiligheid, farmacokinetiek en farmacodynamiek van nipocalimab toegediend aan volwassenen met gegeneraliseerde myasthenia gravis.

Oncologisch studiecentrum

Het Oncologisch Studiecentrum neemt deel aan wetenschappelijk onderzoek rond kankerbehandeling. Ondanks de grote vooruitgang die de laatste decennia op het vlak van kankerbehandeling geboekt is, genezen patiënten niet altijd. Daarom is het noodzakelijk om door middel van wetenschappelijk onderzoek te blijven zoeken naar nieuwe behandelingsmethoden. Naast de bestaande medicatie zijn tal van geneesmiddelen ter bestrijding van kanker nog in ontwikkeling.

Studieteam

• Medisch oncologen:
  • Dr. Stefanie De Waele
  • Dr. Glen Meert
  • Dr. Vincent Renard
  • Dr. Daphne Serruys
• Longartsen
  • Dr. Eveline Claeys
  • Dr. Elke Govaerts
  • Dr. Olivier Van Kerkhove
• Hematologen
  • Dr. Maxim Clauwaert
  • Dr. Ine Moors
  • Dr. Eva Steel

Lopende studies

Gynaecologische oncologie

• DESTINY- Ovarian01: This study is a Phase 3, Open-label, Multicenter, Randomized Study of Trastuzumab Deruxtecan with Bevacizumab Versus Bevacizumab Monotherapy as Firstline Maintenance Therapy in HER2-Expressing Ovarian Cancer.
• Gloriosa: Randomized, multicenter, open-label, Phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with FRα-high recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed after second-line platinum-based chemotherapy plus bevacizumab
• TroFuse-022: A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer
• XPORT-EC-042: A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-type, advanced or recurrent Endometrial Carcinoma.

Senologische oncologie

• Cambria-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next-Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamox).
• Serena-4: A randomized, multicentre, double-blind, phase III study of AZD9833 (an oral SERD) plus palbociclib versus anastrazole plus palbociclib for the treatment of patients with estrogen receptor-positive, HER2-negative advanced breast cancer who have not received any systemic treatment for advanced disease.
• TROPION-BREAST03: A Study of Dato-DXd With or Without Durvalumab Versus Investigator’s Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy.

Thoracale oncologie

• eVOLVE-Lung02 A Phase III: Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (mNSCLC)
• IMscin4Real: A non-interventional, multicenter, multicohort study to evaluate patient-reported satisfaction, effectiveness and safety of subcutaneous atezolizumab in patients treated in routine clinical practice
• Neo-Coast 2: Een open-label, gerandomiseerde fase II-studie in meerdere centra naar neoadjuvante en adjuvante behandeling bij patiënten met reseceerbare niet-kleincellige longkanker in een vroeg stadium (II tot IIIB)
• RE-ALEC: A multicenter non-interventional cohort study to evaluate the real-world clinical management and outcomes of patients diagnosed with ALK-positive advanced NSCLC treated with alectinib.

Urologische oncologie

• DART trial: Stereotactic body radiotherapy with or without Darolutamide for OligoRecurrent prostate cancer: a randomized phase II trial.
• MEVPRO-3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Mevrometostat (PF-06821497) With Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (MEVPRO-3)
• SGNDV-001/KN-D74: An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and greater).
• Talapro-3 trial: A phase 3, randomized, double-blind study of Talazoparib with Enzalutamide versus placebo with enzalutamide in men with DDR gene mutated metastatic castration-sensitive prostate cancer.

Orthopedie

Studieteam

• Dr. Hans Van der Bracht
• Dr. Luc Verhelst
• Dr. Verstuyft Lotte

Lopende studies

• Claviculafracturen 3D: Klinische, radiologische en 3D analyse van conservatief behandelde claviculafracturen.
• Schouder- en elleboogregister: Aanleggen van een database van de behandeling en follow-up van aandoeningen aan elleboog en schouder.
• Schouderprotheses na borst CA: Reverse schouderprothese bij patiënten met een voorgeschiedenis van borstcarcinoom: een retrospectieve cohort studie.
  claviculafracturen 3D Klinische, radiologische en 3D analyse van conservatief behandelde claviculafracturen.
• Subscapularis saving approach for reversed shoulder arthroplasty: a clinical and radiographical outcome study.

Radiotherapie

Studieteam

• Dr. Wim Duthoy
• Dr. Vanhoutte Ilse
• Dr. Van de Voorde Lien

Lopende studies

• GROINSS: Groningen International Study on Sentinel Nodes in Vulvar Cancer-III, a Prospective Phase II Treatment Trial.
• DART: Stereotactic body radiotherapy with or without Darolutamide for OligoRecurrent prostate cancer: a randomized phase II trial.
• ProCaLung: The Project on Cancer of the Lung.
• 1811 - E2-RADiaTE - 1822 - Oligocare 1811: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe 1822: A pragmatic observational cohort study to evaluate radical radiotherapy for oligo-metastatic cancer patients.

Spoedgevallen

Studieteam

• Dr. Kristof Buyse
• Dr. Philippe Leune

Lopende studies

• Spiking spoed: Kenmerken van spiking in Gent - een multicentrisch prospectief observationeel onderzoek.
• Aanmeldingstraject: Het aanmeldingstraject van patiënten op spoedgevallenzorg. Een prevalantiestudie binnen de niet-planbare zorg.