Nationwide comprehensive gastro-intestinal cancer cohorts: the 3P initiative

Background: The increasing sub-classification of cancer patients due to more detailed molecular classification of tumors, and limitations of current trial designs, require innovative research designs. We present the design, governance and current standing of three comprehensive nationwide cohorts including pancreatic, esophageal/gastric, and colorectal cancer patients (NCT02070146). Multidisciplinary collection of clinical data, tumor tissue, blood samples, and patient-reported outcome (PRO) measures with a nationwide coverage, provides the infrastructure for future and novel trial designs and facilitates research to improve outcomes of gastrointestinal cancer patients. Material and methods: All patients aged ≥18 years with pancreatic, esophageal/gastric or colorectal cancer are eligible. Patients provide informed consent for: (1) reuse of clinical data; (2) biobanking of primary tumor tissue; (3) collection of blood samples; (4) to be informed about relevant newly identified genomic aberrations; (5) collection of longitudinal PROs; and (6) to receive information on new interventional studies and possible participation in cohort multiple randomized controlled trials (cmRCT) in the future. Results: In 2015, clinical data of 21,758 newly diagnosed patients were collected in the Netherlands Cancer Registry. Additional clinical data on the surgical procedures were registered in surgical audits for 13,845 patients. Within the first two years, tumor tissue and blood samples were obtained from 1507 patients; during this period, 1180 patients were included in the PRO registry. Response rate for PROs was 90%. The consent rate to receive information on new interventional studies and possible participation in cmRCTs in the future was >85%. The number of hospitals participating in the cohorts is steadily increasing. Conclusion: A comprehensive nationwide multidisciplinary gastrointestinal cancer cohort is feasible and surpasses the limitations of classical study designs. With this initiative, novel and innovative studies can be performed in an efficient, safe, and comprehensive setting

Accuracy of upper endoscopies with random biopsies to identify patients with gastric premalignant lesions who can safely be exempt from surveillance

Introduction: Guidelines recommend endoscopy with biopsies to stratify patients with gastric premalignant lesions (GPL) to high and low progression risk. High-risk patients are recommended to undergo surveillance. We aimed to assess the accuracy of guideline recommendations to identify low-risk patients, who can safely be discharged from surveillance. Methods: This study includes patients with GPL. Patients underwent at least two endoscopies with an interval of 1–6 years. Patients were defined ‘low risk’ if they fulfilled requirements for discharge, and ‘high risk’ if they fulfilled requirements for surveillance, according to European guidelines (MAPS-2012, updated MAPS-2019, BSG). Patients defined ‘low risk’ with progression of disease during follow-up (FU) were considered ‘misclassified’ as low risk. Results: 334 patients (median age 60 years IQR11; 48.7% ma

Nationwide comprehensive gastro-intestinal cancer cohorts: the 3P initiative

Background: The increasing sub-classification of cancer patients due to more detailed molecular classification of tumors, and limitations of current trial designs, require innovative research designs. We present the design, governance and current standing of three comprehensive nationwide cohorts including pancreatic, esophageal/gastric, and colorectal cancer patients (NCT02070146). Multidisciplinary collection of clinical data, tumor tissue, blood samples, and patient-reported outcome (PRO) measures with a nationwide coverage, provides the infrastructure for future and novel trial designs and facilitates research to improve outcomes of gastrointestinal cancer patients. Material and methods: All patients aged ≥18 years with pancreatic, esophageal/gastric or colorectal cancer are eligible. Patients provide informed consent for: (1) reuse of clinical data; (2) biobanking of primary tumor tissue; (3) collection of blood samples; (4) to be informed about relevant newly identified genomic aberrations; (5) collection of longitudinal PROs; and (6) to receive information on new interventional studies and possible participation in cohort multiple randomized controlled trials (cmRCT) in the future. Results: In 2015, clinical data of 21,758 newly diagnosed patients were collected in the Netherlands Cancer Registry. Additional clinical data on the surgical procedures were registered in surgical audits for 13,845 patients. Within the first two years, tumor tissue and blood samples were obtained from 1507 patients; during this period, 1180 patients were included in the PRO registry. Response rate for PROs was 90%. The consent rate to receive information on new interventional studies and possible participation in cmRCTs in the future was >85%. The number of hospitals participating in the cohorts is steadily increasing. Conclusion: A comprehensive nationwide multidisciplinary gastrointestinal cancer cohort is feasible and surpasses the limitations of classical study designs. With this initiative, novel and innovative studies can be performed in an efficient, safe, and comprehensive setting

Clinicopathological characteristics of early onset colorectal cancer

BACKGROUND: The rising incidence of early onset colorectal cancer (EOCRC) might reflect a novel tumour entity. AIMS: To evaluate clinicopathological characteristics of sporadic EOCRC (in patients 2005, P = 0.09), and a higher percentage of rectal cancer was found in age group III (34.3%  2005, P < 0.01). Mean overall survival was 6.3 years and improved over time. CONCLUSIONS: EOCRC is not only characterised by age of onset but also by the more frequent presence of signet-ring cells, more poorly differentiated tumours, and higher risk of lymph node metastases. In the most recent years, a higher proportion of rectal cancer was found from the age of 30 years, and a higher proportion of CRCs were diagnosed in females below the age of 30 years

Palliation of dysphagia

Item does not contain fulltextPalliation of dysphagia is the cornerstone of palliative treatment in patients with incurable oesophageal cancer. Available palliative options for dysphagia are oesophageal stent placement and radiotherapy. In general, oesophageal stent placement is the preferred therapeutic option in patients with a relatively poor prognosis because of its rapid relief of dysphagia. Regardless of ongoing technical developments, recurrence of dysphagia and stent-related complications are still occurring. For patients with a relatively good prognosis, intra-luminal brachytherapy is advised because of its sustained palliation of dysphagia. Due to limited availability of intra-luminal brachytherapy in clinical practice, fractionated external beam radiation therapy is commonly applied as an alternative. Selection of the optimal palliative approach for patients remains however challenging as conclusive high-quality evidence is limited. Moreover, with the introduction of new palliative treatment options (e.g. palliative chemotherapeutic and radiotherapeutic options) and the concurrent change of patient characteristics, supporting evidence from large randomised studies is warranted

Self-expandable duodenal metal stent placement for the palliation of gastric outlet obstruction over the past 20 years.

INTRODUCTION: Duodenal stent placement is a palliative option for management of malignant gastric outlet obstruction (GOO). In the last 20 years, management of gastrointestinal cancers has considerably changed. It is unknown if these changes have affected clinical outcome of duodenal stent placement. METHODS: Retrospective cohort study conducted in a tertiary referral center. Patients who underwent duodenal stent placement for GOO-symptoms due to a malignant stricture were included. Primary outcome was GOO-symptom free survival. Secondary outcomes included stent-related adverse event rates. Potential explanatory parameters such as period of stent placement (1998-2009 vs 2010-2019), prior treatments, peritoneal deposits, and stricture length were evaluated using multivariable Cox regression analysis. RESULTS: A total of 147 patients (62 % male; median age 64 years) were included. After a median of 28 days after stent placement, 82 patients (57 %) had recurrent GOO-symptoms. GOO-symptom free survival was significantly lower in 2010-2019 (P < 0.01). Time period was the only independent predictor for reduced GOO-symptom free survival (HR 1.76, P < 0.01). Stent-related adverse event rates increased over time (1998-2009: 31 % vs 2010-2019: 37 %). Prior treatment with chemotherapy and/or radiotherapy was significantly associated with an increased risk of adverse events (OR 2.53, P = 0.02). CONCLUSIONS: Clinical outcome of duodenal stent placement did not improve over time. The decreased GOO-symptom free survival and increased adverse event rate in more recent years are probably related to the chemo- and/or radiotherapy treatment provided prior to duodenal stent placement

Quality assurance of colonoscopy within the Dutch national colorectal cancer screening program

Colorectal cancer (CRC) screening is capable of reducing CRC-related morbidity and mortality. Colonoscopy is the reference standard to detect CRC, also providing the opportunity to detect and resect its precursor lesions: colorectal polyps. Therefore, colonoscopy is either used as a primary screening tool or as a subsequent procedure after a positive triage test in screening programs based on non-invasive stool testing or sigmoidoscopy. However, in both settings, colonoscopy is not fully protective for the occurrence of post-colonoscopy CRCs (PCCRCs). Because most PCCRCs are the result of colonoscopy-related factors, a high-quality procedure is of paramount importance to assure optimal effectiveness of CRC screening programs. For this reason, at the start of the Dutch fecal immunochemical test (FIT)-based screening program, quality criteria for endoscopists performing colonoscopies in FIT-positive screenees, as well as for endoscopy centers, were defined. In conjunction, an accreditation and auditing system was designed and implemented. In this report, we describe the quality assurance process for endoscopists participating in the Dutch national CRC screening program, including a detailed description of the evidence-based quality criteria. We believe that our experience might serve as an example for colonoscopy quality assurance programs in other CRC screening programs

Diagnostic Accuracy of Stool Tests for Colorectal Cancer Surveillance in Hodgkin Lymphoma Survivors

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