Mitigating Toxicity of (Neo)Adjuvant Chemotherapy by Applying Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects: the Prospective Randomized eChemoCoach Trial

Chemotherapy induces side effects varying in severity, impacting patients' quality of life and necessitating unplanned hospital care. Patient-reported outcomes (PROs) could aid in early detection and management of side effects. However, existing PRO monitoring lacks triage capabilities, leading to clinician involvement and suboptimal symptom management. The investigators propose eChemoCoach, an electronic questionnaire integrated into the electronic health portal, offering real-time symptom assessment and personalized advice based on CTCAE criteria. Our study aims to assess the impact of eChemoCoach on non-hematological CTCAE ≥ 3 graded side effects in early breast cancer patients undergoing chemotherapy. This is a randomized controlled trial involving 746 patients that will evaluate the eChemoCoach's efficacy compared to standard monitoring. Phase one will validate questionnaires and assess usability, while phase two focuses on the primary outcome. Te investigators anticipate reduced severe side effects, thereby enhancing patients' quality of life, reducing stress, and minimizing hospital visits.

开始日期2025-06-01

申办/合作机构

Noordwest Ziekenhuisgroep

[+2]

NCT06096883 / Not yet recruitingN/A

Development of Acetabular Erosion After Hemiarthroplasty: an Exploratory Retrospective Study

The aim of this exploratory retrospective study is to gain a better understanding about the occurrence of acetabular erosion in patients after after hip hemiarthroplasty. The main objectives are i) to summarise a selection of basic patient characteristics of all patients of ≤ 75 years of age with a femoral neck fracture who have received either HA or THA, ii) to explore the proportion of patients after HA who developed acetabular erosion in the first years post-surgery and iii) to explore the proportion of patients after HA for whom acetabular erosion was the main reason for conversion surgery from HA to THA. A secondary objective is to assess the observer reliability of, and explore the association between, the Baker classification grading and Köhler line measurements.
All participants approached for participation in the main phase of the study will be asked to give their written informed consent to use their patient data. Patients who are willing to participate will also be asked to complete a short paper survey to collect data that is not available from their health records.

开始日期2024-08-01

申办/合作机构

Stichting Máxima Medisch Centrum

[+3]

NCT06644716 / RecruitingN/AIIT

[18F]F-FAPI PET-CT to Identify Carcinoma of Unknown Primary Origin

The investigators will determine the proportion of CUP patients in whom the primary tumor can be identified by [18F]F-FAPI PET-CT.

开始日期2024-07-19

申办/合作机构

Academisch Ziekenhuis Maastricht

[+2]

100 项与 Noordwest Ziekenhuisgroep 相关的临床结果

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0 项与 Noordwest Ziekenhuisgroep 相关的专利（医药）

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2024-05-02·Cancer Research

Abstract PO1-14-11: Different molecular processes are associated with recurrence in the clinical high- genomic low risk (cH/gL) and clinical low- genomic high risk (cL/gH) groups of the MINDACT clinical trial

作者: Maetens, Marion ; Pierga, Jean-Yves ; Brain, Etienne ; Aalders, Kim ; Neijenhuis, Peter A ; Hilbers, Florentine ; De Meulemeester, Laura ; Delorenzi, Mauro ; Cardoso, Fatima ; Viale, Giuseppe ; Piccart, Martine ; Poncet, Coralie ; Veer, Laura Van ’t ; Sotiriou, Christos ; Nguyen, Ha-Linh ; Desmedt, Christine ; Rutgers, Emiel ; Vrijaldenhoven, Suzan ; Richard, François ; Delaloge, Suzette

AbstractBackground: Despite the growing understanding of estrogen receptor positive/HER2-negative (ER+/HER2-) breast cancer (BC) biology, many unknowns remain regarding the mechanisms of disease recurrence. While several multigene prognostic signatures have shown clinical utility in identifying those patients at high or low genomic risk of recurrence, they can present with some limitations. In this retrospective analysis of the MINDACT trial, we interrogated the available transcriptomic data to understand which biological characteristics of the tumor are associated with recurrence in patients from the clinical high- genomic low risk (cH/gL) and clinical low- genomic high risk (cL/gH) groups (where the clinical and genomic risk were defined by a modified version of Adjuvant Online! and the 70-gene signature, respectively). Methods: These analyses focused on the subset of patients with ER+/HER2- tumors of no special type (NST) who received endocrine therapy (which comprised the majority of this NST ER+/HER2- sub-cohort) and for which central pathology and gene expression data were available (n= 1245). Scores of gene expression modules associated with key biological processes in breast cancer defined in a collection of previous publications were computed from the gene expression matrix using the formula described in Desmedt et al. (Clin. Cancer Res. 2008). Gene Set Variation Analysis method (R package ‘GSVA’ – version 1.40.1) was used to derive the enrichment scores of fifty hallmark gene sets available in the ‘H’ collection of the MSigDB database (version 7.5.1). Survival analyses were performed for disease-free survival (DFS) and distant recurrence-free survival (DRFS). Univariable and multivariable regression models, implemented by Cox regression and Fine-Gray subdistribution hazard regression methods, were performed to evaluate the association of enrichment of hallmarks and gene modules with DFS and DRFS, respectively (covariates =age, nodal status, KI67, tumor size, chemotherapy, radiotherapy). Results: DFS event occurred in 150/913 (16.4%) and 51/332 (15.4%) NST ER+/HER2- patients in the cH/gL and cL/gH groups, respectively. DRFS event occurred in 70/913 (7.7%) and 21/332 (6.3%) NST ER+/HER2- patients in the cH/gL and cL/gH groups, respectively. In the cH/gL group, we observed an association of hallmarks related to cell cycle and downregulation of gene modules related to lymphocyte-centric immune activities with worse prognosis (Table). For the cL/gH, we did not observe an association between hallmarks related to cell cycle and worse prognosis but an enrichment of hallmarks related to PI3K/AKT/mTOR signaling as well as several metabolic hallmarks related to insulin activities (Table). Of interest, in this group of patients, higher scores of the HER2-associated gene expression signature were also associated with worse prognosis. Across the two groups effects were more pronounced for DRFS than DFS. Conclusion: Different molecular processes are associated with progression in these two distinct groups of patients. The association of hallmarks related to cell cycle with survival in the cH/gL group supports the observation that adjuvant chemotherapy could benefit a subset of these patients. In the cL/gH group, the association of signatures associated with PI3K pathway and HER2 can have potential clinical relevance given their current targetability in the metastatic setting. This retrospective study is funded by the Breast Cancer Research Foundation.Table. Representative hallmarks and gene expression modules independently associated with prognosis in NST ER+/HER2- patients in the cH/gL group and in the cL/gH group #p-values reported were not corrected for multiple testingCitation Format: Christine Desmedt, Ha-Linh Nguyen, François Richard, Marion Maetens, Coralie Poncet, Laura De Meulemeester, Kim Aalders, Mauro Delorenzi, Suzette Delaloge, Jean-Yves Pierga, Etienne Brain, Suzan Vrijaldenhoven, Peter A Neijenhuis, Emiel Rutgers, Florentine Hilbers, Laura Van ’t Veer, Giuseppe Viale, Christos Sotiriou, Martine Piccart, Fatima Cardoso. Different molecular processes are associated with recurrence in the clinical high- genomic low risk (cH/gL) and clinical low- genomic high risk (cL/gH) groups of the MINDACT clinical trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-14-11.

2023-03-01·Cancer Research

Abstract P5-14-01: Transcriptomic insights into lobular breast cancer biology: a retrospective analysis of the MINDACT clinical trial

作者: Pierga, Jean-Yves ; Wesseling, Jelle ; Vrijaldenhoven, Suzan ; Viale, Giuseppe ; Rutgers, Emiel ; Delorenzi, Mauro ; Neijenhuis, Peter A ; Linn, Sabine ; Maetens, Marion ; Hilbers, Florentine ; Van Baelen, Karen ; Piccart, Martine ; Nguyen, Ha-Linh ; Metzger, Otto ; Desmedt, Christine ; Brain, Etienne ; Van ’t Veer, Laura ; Poncet, Coralie ; Cardoso, Fatima ; Delaloge, Suzette ; Richard, François ; Aalders, Kim

AbstractBackground: Invasive lobular carcinoma (ILC) represents the second most common subtype of breast cancer after invasive breast cancer of no special type (NST). In this retrospective analysis of the MINDACT trial, we aimed at identifying/refining the transcriptomic differences between: 1) estrogen receptor positive/HER2-negative (ER+/HER2-) ILC versus ER+/HER2- NST, 2) classic and non-classic ER+/HER2- ILC, and, 3) recurring and non-recurring ER+/HER2- ILC in the subgroup of patients with a low clinical and low genomic (cL/gL) risk (as defined by a modified version of Adjuvant Online! and the 70-gene signature). Patients and methods: Central pathology review was performed for histological subtype, grade and Ki67 (G.V.) for 5929/6693 (88.6%) of the patients included in the MINDACT trial (NCT00433589). Analysis of transcriptomic data adjusted for age and grade was performed using the R/Bioconductor package ‘limma’ to identify differentially expressed genes (DEGs). DEGs having absolute log-fold change (logFC)≥ 0.2 and FDR-adjusted p-value (q-value) < 0.05 were considered. Gene set enrichment analyses (GSEA) of MSigDB hallmark gene sets were performed. Adjusted Cox regression models were used to evaluate the association of these hallmarks with disease free survival (DFS) and distant recurrence free survival (DRFS). Results: After central pathological review, 464 patients with ER+/HER2- ILC and 3798 patients with ER+/HER2- NST were identified. Patients with ILC were significantly older at diagnosis, had larger tumors, less axillary nodal involvement, more grade 2 tumors than patients with NST. At the transcriptomic level, we observed a high number of DEGs between these 2 subgroups, confirming their distinct phenotype. CDH1, the gene coding for E-cadherin, was as expected the most highly overexpressed gene in NST versus ILC. We further observed an increased expression of leptin (LEP), leptin receptor (LEPR), lipoprotein lipase (LPL), and the fatty acid transporter CD36 in ILC. This could suggest that ILC relied on increased lipid uptake thanks to the increased contact of ILC tumor cells with the adipocytes. IGF1 was also overexpressed in ILC versus NST, as a potential consequence of high LEP and high LEPR expression. Differences were also evident with regard to the extracellular matrix (ECM), with many collagens, matrix metalloproteinases (MMPs) and other key enzymes (e.g. LOXL1) being differentially expressed. We confirmed a decreased ER-signaling and increased PI3K/Akt signaling in ILC versus NST. Out of the 464 ER+/HER2- ILC tumors, 253 (55%) were classic ILC and 211 (45%) non-classic ILC. There were more grade 3 tumors, more highly proliferative tumors and more nodal involvement in patients with non-classic versus classic ILC. At the transcriptomic level, differences were subtler than the differences seen above. Still, a significant enrichment of the hallmarks related to cell cycle in the non-classic ILC, and of the hallmarks related to epithelial-to-mesenchymal transition, hypoxia, adipogenesis and IL6/JAK/STAT3 signaling in classic ILC was observed. Finally, 216/464 patients with ER+/HER2- ILC (47%) were assigned to the cL/gL risk group and did not receive chemotherapy. 28/216 of these patients (13%) relapsed (DFS, median FU: 8.7 years). Enrichment of hallmarks related to apoptosis, inflammatory response, hypoxia and oncogenic signaling (PI3K/Akt, Ras, c-Myc) was associated with worse survival. Conclusion: This represents, to the best of our knowledge, the largest set of gene expression data for patients with ILC, issued from a clinical trial where histology was reviewed centrally. These results could be used to personalize treatment for patients with ILC. This project is funded by the Breast Cancer Research Foundation.Citation Format: Christine Desmedt, Ha-Linh Nguyen, François Richard, Sabine Linn, Otto Metzger, Coralie Poncet, Jelle Wesseling, Florentine Hilbers, Kim Aalders, Mauro Delorenzi, Suzette Delaloge, Jean-Yves Pierga, Etienne Brain, Suzan Vrijaldenhoven, Peter A Neijenhuis, Karen Van Baelen, Marion Maetens, Emiel Rutgers, Martine Piccart, Laura Van ’t Veer, Giuseppe Viale, Fatima Cardoso. Transcriptomic insights into lobular breast cancer biology: a retrospective analysis of the MINDACT clinical trial [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P5-14-01.

2021-03-01·ESGE Days 2021

Adherence to Mismatch Repair Testing Guidelines in PT1 Colorectal Carcinomas Diagnosed Before the age of 70 Years