Clinical Research Trial UnitClinical Research Trial Unit
Lieselot Croes, Stefanie Dias, Mieke Van Den Berghe and Annelies Verkest and Flore Ryckebusch and Flore Herman are the study coordinators for Medical Oncology. Danielle Delombaerde works closely with the study team as a scientific researcher.
Lieselot Croes graduated from the University of Antwerp with a Master’s Degree in Molecular and Cellular Biomedical Sciences in 2012. She then completed her doctorate research in Medical Sciences (Oncology/Epigenetics). For her thesis titled ‘GSDME, from Tumour Suppressor Gene to Biomarker‘, she received the highest academic degree (PhD) in 2019 from the Antwerp Doctoral School (University of Antwerp). In addition, since May 2020, she has given scientific guidance for the clinical study department for medical oncology. Since January 2020, she has worked at the Maria Middelares General Hospital as a doctor specialist assistant, where she supports Dr Vulsteke during consultations and scientific research.
Stefanie Dias graduated in 2008 with a Professional Bachelor's degree in Midwifery from the Artevelde University of Applied Sciences in Ghent. She then received her Master's Degree in Health care Management and Policy in 2010 from the University of Ghent. She worked for six years as a midwife at Maria Middelares General Hospital and, in 2017, transferred to the Clinical Study Department for Medical Oncology. Since May 2020, she has lead the team in operations as a study coordinator.
Mieke Van Den Berghe graduated from the University of Antwerp in 2002 with her Master's Degree in Biomedical Sciences. She subsequently obtained another degree in Biology. She carried out clinical research for large pharmaceutical companies for 12 years In November of 2016, she started working at Maria Middelares General Hospital as a study coordinator for the development of cancer medication.
Annelies Verkest graduated in 2008 with her professional Bachelor's Degree in Midwifery from the Artevelde University of Applied Sciences in Ghent. In 2016, she received her Master's Degree in Nursing and Midwifery from the University of Ghent. She worked for eleven years as a midwife at Maria Middelares General Hospital and, in August 2019, transferred to the Clinical Study Department for Medical Oncology.
Flore Ryckebusch graduated in 2012 with a professional Bachelor's Degree in Nursing from the Catholic University College in Kortrijk. In 2016, she received her Master's Degree in Nursing and Midwifery from the University of Ghent. She worked for five years as a theatre nurse at Maria Middelares General Hospital and, in September 2020, transferred to the Clinical Study Department for Medical Oncology.
Flore Herman graduated in 2014 with a Professional Bachelor's Degree in Nursing from the Artevelde University of Applied Sciences in Ghent. In 2016, she received her Master's Degree in Nursing and Midwifery from the University of Ghent. She worked as a nurse at the Oncology/Haematology Department of the St Lucas General Hospital in Ghent and at the Gastro-oncology Department of Ghent University Hospital. She joined the Medical Oncology Study Team in February 2021. She currently combines this with a job at Ghent University Hospital as an oncology researcher.
Danielle Delombaerde graduated in 2019 from the University of Ghent with a Master’s Degree in Pharmaceutical Care. She then worked as a deputy pharmacist in two pharmacies. Since 2020, she has worked at Maria Middelares General Hospital as a scientific researcher, completing a PhD in the prediction of immunotherapy-related toxicities under the supervision of Prof. Dr Vulsteke and Dr Croes.
Clinical Trial Manager Assistant:
The Medical Oncology Study Team is managed by:
Mastology StudiesMastology Studies
Adjuvant HER2 negative
- EORTC 1745: A Phase II Study of Adjuvant PALbociclib as an Alternative to Chemotherapy in Elderly Patients with High-Risk ER+/HER2 - Early Breast Cancer (APPALACHES).
- MK3475-756: Study of Pembrolizumab (MK-3475) Versus Placebo in Combination with Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756).
- DS8201-A-U301 - Daichi: A Phase 3, Multi-centre, Randomised, Open-Label, Active-Controlled Trial of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC), Versus Treatment of Investigator's Choice for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated with Prior Standard of Care HER2 Therapies, Including T-DM1.
- IPSOC mamma: Prospective, non-interventional, non-controlled multi-centre observational study to evaluate aspects of pharmaceutical care and the treatment of postmenopausal patients with hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with everolimus and examestane.
Urology StudiesUrology Studies
- PCR 3001 Janssen: A Study of Niraparib in Combination with Abiraterone Acetate and Prednisone versus Abiraterone Acetate and Prednisone for Treatment of Participants with Metastatic Prostate Cancer.
- AARDVARC: A phase II, open-label, study to assess the efficacy, safety, and tolerability of AZD4635 in combination with durvalumab and in combination with cabazitaxel and durvalumab in patients who have progressive metastatic castrate-resistant prostate cancer.
- CAPItello-281: A phase III double-blind, randomised, placebo-controlled study assessing the efficacy and safety of capivasertib + abiraterone versus placebo + abiraterone as treatment for patients with de novo metastatic hormone-sensitive prostate cancer (mHSPC) characterised by PTEN deficiency.
- BMS: CA017-078: A Study of Chemo-only versus Chemo-plus Nivmo with or without BMS-986205, Followed by Post-surgery Therapy with Nivo or Nivo and BMS-986205 in Patients with MIBC.
- MK 3475-866: Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-8666/KEYNOTE-866) (KEYNOTE-866).
- MK 3475-905: Perioperative Pembrolizumab (M-3475) Plus Cystectomy versus Cystectomy Alone in Cisplatin-ineligible Participants with Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905).
- KEYNOTE 676: Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Bacillus Calmette-Guerin (BCG) in High-risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676).
- THOR: BLC3001:A Study of Erdafitinib Compared with Vinflunine or Docetaxel or Pembrolizumab in Participants with Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations.
- THOR- 2: BLC2003: A randomized phase 2 study of erdafitinib versus investigator choice of intravesical chemotherapy in subjects who received bacillus calmette-guérin (BCG) and recurred with high risk non-muscle-invasive bladder cancer (NMIBC) and FGFR mutations or fusions.
- SGN22E-003/ EV-302: An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab versus chemotherapy alone in previously untreated locally advanced of metastaic urothelial cancer.
Gynaecology StudiesGynaecology Studies
- ENGOT-ov50/ INNOVATE-3: Pivotal, randomized, open-label study of tumor treating fields (TTFields, 200kHz) concomitant with weekly paclitaxel for the treatment of platinum-resistant ovarian cancer (PROC).
- ENGOT-ov43/ KEYLYNCK-001: A randomized phase 3, double-blind study of chemotherapy with or without pembrolizumab followed by maintenance with olaparib or placebo for the first-line treatment of BCRA non-mutated advanced epithelial ovarian cancer (EOC).
- SGNTV-002/innovaTV 208: Open label phase 2 study of tisotumab vedotin for patients with platinum-resistant ovarian cancer with a safety run-in of a dose dense regimen.
- ENGOT-EN9/ MK-7902-001-04: A phase 3 randomized, open-label, study of pembrolizumab (MK-3475) plus lenvatinib (E7080/MK-7902) versus chemotherapy for first-line treatment of advanced or recurrent endometrial carcinoma (LEAP-001).
Melanoma StudiesMelanoma Studies
- E011-MEL: A phase Ib open label study to assess the safety and tolerability of ECI-006 mRNA immunotherapy by intranodal administration to melanoma patients following surgical resection in Cohort 1 and by intranodal or intratumoral administration on top of first line standard of care pembrolizumab in patients with advanced or metastatic melanoma in Cohort 2.
- CA209-76K: A phase 3, randomized, double-blind study of adjuvant immunotherapy with nivolumab versus placebo after complete resection of stage IIB/C melanoma
Other StudiesOther Studies
AMTRA: Ambulant Monitoring of Cancer Therapy using a smaRtphone Application.