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Intraoperative endoscopic pylorus dilatation during minimally invasive Ivor Lewis oesophagectomy to prevent delayed gastric conduit emptying (DGCE): protocol for the WIDE randomised controlled trial.5 days agoOesophageal cancer has a poor prognosis and oesophagectomy has increasingly adopted minimally invasive techniques, but delayed gastric conduit emptying (DGCE) still occurs in ~10-50% of patients, depending on the used diagnostic criteria and definitions. DGCE can cause serious complications, such as aspiration pneumonia, and it prolongs hospital stay and the overall morbidity of patients. Surgical pyloric drainage procedures (pyloroplasty or pyloromyotomy) have not clearly improved outcomes. Endoscopic pyloric balloon dilatation (EPBD) effectively treats established DGCE, and emerging evidence suggests that prophylactic EPBD may reduce its incidence. However, no randomised trial has evaluated intraoperative EPBD during minimally invasive oesophagectomy until now. The WIDE trial will test whether adding an EPBD during oesophagectomy can prevent early postoperative DGCE.
WIDE is a single-centre, double-blind randomised controlled trial, in which 116 adult patients undergoing minimally invasive Ivor Lewis oesophagectomy for oesophageal cancer are randomly assigned to intraoperative endoscopic pyloric balloon dilatation (30 mm EPBD) versus no pyloric intervention. Patients with prior gastric surgery, non-curative disease or American Society of Anesthesiologists class V are excluded. The EPBD is following induction of general anaesthesia and endotracheal intubation, and immediately prior to or concomitant with the start of the surgical procedure in the operating room. Control patients will receive standard surgery without any pyloric procedure. Patients and outcome assessors are blinded to the groups. The primary outcome is early DGCE after 5 and 10 days post-op, defined as nasogastric tube output ≥500 mL on postoperative day 5 or later and/or >100% increase in gastric conduit width on imaging (vs immediate post-op baseline). Key secondary outcomes include DGCE at 3 months, postoperative complication rates (eg, anastomotic leak, pneumonia, aspiration), recovery metrics (time to first bowel movement, time to resume solid food, vomiting episodes), length of hospital and ICU stay, and 3-month quality of life. Analysis will follow the intention-to-treat principle. A sample size of 104 patients (52 per arm) provides 80% power to detect a meaningful reduction in DGCE incidence (α=0.05). The target enrolment is 116 to allow for ~10% attrition.
The protocol (V.1.3) has been approved by the Northwestern and Central Switzerland Ethics Committee (EKNZ; BASEC 2025-01877). Written informed consent will be obtained from all participants. The trial is classified as a Category A (minimal-risk) study under the Swiss Human Research Act and Clinical Trials Ordinance (ClinO). Findings will be disseminated in peer-reviewed journals and conference presentations, as well as in our in-hospital journal in a lay version for patients.
NCT07355374.CancerAccessCare/ManagementAdvocacy -
Understanding LUng Cancer risk factors and their Impact Assessment (LUCIA): protocol for multicentre observational cohort study.5 days agoLung cancer (LC) is the leading cause of cancer-related mortality worldwide, primarily due to diagnosis at advanced stages. Although low-dose computed tomography (LDCT) screening reduces lung cancer mortality in high-risk populations, current screening programmes are largely restricted to individuals defined by age and smoking history. This approach excludes never-smokers and individuals with non-smoking-related risk factors, limiting the equity, efficiency and scalability of lung cancer screening. The LUng Cancer risk factors and their Impact Assessment (LUCIA) project aims to overcome these limitations by developing personalised lung cancer risk prediction models and evaluating novel non-invasive technologies for early detection within a risk-adapted screening strategy.
LUCIA is a multicentre, observational, longitudinal cohort study that will recruit approximately 4000 participants across four European regions: Andalusia and the Basque Country (Spain), Liège (Belgium) and Riga (Latvia). The study population includes smokers, never-smokers and reduced smokers with low-to-moderate lung cancer risk. All participants will initially enter phase 1 (wide population screening) and may transition to phase 2 (precision screening) or phase 3 (diagnosis) based on LDCT findings, results from non-invasive screening devices and artificial intelligence-based risk prediction models. Participants will be followed up for 24 months, with assessments at baseline and at 6, 12 and 24 months. Data collection includes sociodemographic characteristics, medical history, environmental and occupational exposures, lifestyle factors, spirometry, multi-omics profiles and outputs from novel non-invasive devices, including a breath analyser, spectrometry-on-card and a skin-applied volatile organic compound sensing patch. The study will develop and validate integrated lung cancer risk prediction models and evaluate the diagnostic performance of these technologies to support population stratification and personalised screening.
The study will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and applicable national and European regulations. Ethical approval has been obtained from the relevant ethics committees in all participating countries. Written informed consent will be obtained from all participants. Study findings will be disseminated through peer-reviewed open-access publications, scientific conferences and communication with public health stakeholders.
ClinicalTrials.gov, NCT06473870.CancerChronic respiratory diseaseAccessCare/ManagementAdvocacyEducation -
Pre-diagnostic route reported by patients with sarcoma from the Netherlands, the UK, Australia and New Zealand: early detection challenges for general practitioners - an international observational cohort study.5 days agoTo investigate how patients with sarcoma present prior to diagnosis-through a general practitioner (GP) or another healthcare professional (HCP)-and describe presenting symptoms.
International observational cohort study.
Data were obtained from the longitudinal 'QUality of life and Experiences of Sarcoma Trajectories' (QUEST) cohort study, conducted across the Netherlands, the United Kingdom (UK), Australia and New Zealand.
Among 572 patients, 487 (85.1%) started their diagnostic trajectory at the GP (subcohort 1) and 85 (14.9%) with another HCP (subcohort 2)-mainly medical specialists treating unrelated conditions (36/85; 42.4%). Soft tissue sarcoma patients most often reported swelling, whereas bone sarcoma patients reported unexplained pain. Notably, 31/85 (36.5%) of subcohort 2 were asymptomatic. Reasons for delaying GP visits included assuming symptoms were minor and expecting them to resolve. Patients sought care when, among others, symptoms persisted and worsened.
Most patients first consulted a GP, underlining the role of primary care in sarcoma diagnosis internationally. Due to rarity and nonspecific symptoms, faster diagnosis remains challenging, requiring improvements in both primary and specialist care.
NCT03441906; Results.CancerAccessCare/ManagementAdvocacy -
Cancer survival and its social determinants among children with a migrant background: systematic review protocol.5 days agoChildhood cancer survival rates are not equal for all, with disparities existing both between and within low- and middle-income countries and high-income countries, particularly among ethnic minorities and children with migrant backgrounds. Factors such as cultural misunderstandings, language barriers and limited support networks can lead to delays in diagnosis and treatment challenges, which can result in poor health outcomes. Social determinants of health (SDoH), such as housing insecurity and poverty, may worsen these disparities. This protocol outlines a systematic review to examine childhood cancer survival in children with migrant backgrounds compared with non-migrants and to explore the SDoH associated with these survival outcomes.
We will search MEDLINE (PubMed), Scopus, Web of Science, and Embase for relevant studies, with secondary searches of grey literature. Two reviewers will screen for observational studies, including longitudinal cohort, case-control, cross-sectional and registry-based studies, that report childhood cancer survival outcomes (eg, survival rates, HRs) for both migrant and non-migrant populations. A narrative synthesis will explore SDoH and their association with survival outcomes. If data allow, we will perform random-effects meta-analyses to estimate pooled survival outcomes. Subgroup analyses will examine factors such as geographic region, migration status and type of cancer.
Understanding factors contributing to childhood cancer survival disparities in migrant populations is critical for informing the development of targeted strategies to address them, ensuring all children, regardless of their migration status, have an equitable opportunity for effective care and improved outcomes.
Ethical approval is not required for this study as it is based on previously published data and does not involve primary data collection. We will publish the results in peer-reviewed journals and present at academic conferences.
CRD42024547239.CancerAccessCare/ManagementAdvocacy -
RNI Precision Trial Protocol: Optimization of Regional Node Irradiation for Sentinel Lymph Node-positive Breast Cancer Omitting Axillary Dissection Based on Clinical and Genomic Risk Assessment: A Prospective Clinical Trial.5 days agoBackgroundSentinel lymph node biopsy (SLNB) has been the standard treatment procedure for clinically node-negative (cN0) breast cancer (BC). Three randomized trials (Z0011, AMAROS and SENOMAC) have shown that patients with low-burden sentinel lymph node metastasis can be safely omitted axillary lymph node dissection who receive adjuvant radiotherapy. However, these published studies have been insufficient to accurately assess the recurrence risk in this patient population, leading to variability in adjuvant radiotherapy volume across different studies.ObjectiveThis study evaluates whether an integrated axillary management strategy combining SLNB with individualized regional nodal irradiation (RNI) based on recurrence risk reduces 2-year lymphedema compared to ALND followed by comprehensive RNI.Materials and MethodsThis trial is a single institute, open-labeled, non-randomized cohort trial. Participants are stratified into two cohorts based on the extent of axillary surgery after enrollment. For SLNB cohort, patients are divided into three groups according to clinical and genomic risk assessment. Clinically high-risk patients are defined as having at least two factors (tumor size≥2cm, percent of positive SLNs>30%, LVI positive and SLN macro-metastases), who have a predicted risk of n-SLN involvement greater than 30%. Clinically high-risk n-SLN involvement patients are further detected by using RecurIndex test. For pathological node positive (pN+) after ALND cohort, patients are treated with WBI/chest wall irradiation combined with comprehensive RNI excluding the dissected axillary region; A total of 205 patients will be enrolled, with 68 patients in SLNB cohort and 137 patients in ALND cohort with a 1:2 ratio assignment. The RNI precision trial uses a clinical-genomic model to accurately stratify the recurrence risk and provides the individualized RNI volume for early-stage BC with low-burden sentinel lymph node metastasis, and we anticipate that our study will provide high-quality data to potentially support individualized RNI in this patient population.CancerAccessCare/ManagementAdvocacyEducation
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Temporal trends in cancer incidence in a Peruvian population of the Social Health Insurance between 2000 and 2020.5 days agoCancer is one of the leading causes of disease burden in Peru, with significant regional disparities in incidence and mortality. The Moquegua region has experienced a sustained increase in risk factors and cancer burden without systematic studies to characterize its epidemiological profile. The objective of this study was to estimate the temporal trend in cancer incidence and describe its characteristics in the population insured by Social Health Insurance in Moquegua between 2000 and 2020.
A retrospective study was conducted based on institutional records of patients with cancer confirmed by pathological anatomy at Hospital Base II, Moquegua. Crude and age-adjusted incidence rates were calculated. Additionally, a joinpoint regression model was applied to analyze temporal trends. The analysis was stratified by sex and anatomical location. Furthermore, five-year overall survival was calculated for the most common neoplasms.
A total of 545 new cancer cases were identified during the study period. The overall age-adjusted incidence rate was 30.2 per 100 000 insured individuals, with a higher prevalence among women (55.2%). A significant upward shift was observed between 2013 and 2017. The most common sites were: breast (19.4%), prostate (18.0%), cervix (7.5%), colorectal (7.3%), and thyroid (7.0%). Breast cancer had the highest incidence rate; thyroid cancer had a survival rate close to 100%, while prostate cancer had the lowest overall survival rate.
The incidence of cancer in Moquegua has shown an upward trend since 2013, possibly associated with improvements in diagnostic capacity. Rates were higher among women, with a predominance of neoplasms common at the national level. These findings underscore the need to strengthen cancer surveillance through a territorial approach and to improve access to early-diagnosis services and timely treatment.CancerAccessAdvocacy -
Physician Perspectives on ChatGPT-4o as a Patient Resource for Abdominal Cancer Surgeries: Cross-Sectional Survey.5 days agoArtificial intelligence (AI) models are being increasingly integrated into clinical care. Moreover, the availability of publicly accessible AI resources makes them attractive to patients seeking clinical information. Little is known regarding the use of large language models as patient resources for navigating major cancer diagnoses.
This study aimed to evaluate the content, readability, and safety of ChatGPT (OpenAI; GPT-4o)-generated responses to common perioperative queries about hepatic, pancreatic, and colon cancers.
A 28-question survey was developed based on frequently asked surgical questions for select malignancies. Surgical oncologists rated ChatGPT-4o-generated responses on a 5-point Likert scale for accuracy, quality, and tangibility. Readability was assessed using the Flesch-Kincaid Reading Grade Level (FKRGL) and Flesch Reading Ease (FRE). Respondents provided free-text comments and reported their comfort with patients using ChatGPT. Survey completion implied consent.
A total of 7 attending surgical oncologists with a median of 7 (IQR 4-13) years in practice completed the survey. Responses received mean scores of 3.5/5 (SD 0.28) for quality, 3.6/5 (SD 0.34) for accuracy, and 3.6/5 (SD 0.29) for tangibility. The responses had a median FKRGL score of 14.6 (IQR 13.3-15.6) and FRE score of 29.4 (IQR 20.5-36.3). On a post hoc analysis for select questions, the median FKRGL was 15.6 (IQR 14.4-16.7), decreasing to 7.1 (IQR 6.1-8.3) and 14.5 (IQR 13.2-15.4) with prompting and rephrasing, and the median FRE was 18.1 (IQR 14.6-24.7), increasing to 73.8 (IQR 66.6-79.3) and 32.0 (IQR 27.0-37.7) with prompting and rephrasing. Numerous inaccuracies and content gaps were reported, and approximately 43% (3/7) of providers did not report feeling "comfortable" in having patients consult publicly available AI for medical information.
This study provides cautionary, yet optimistic, findings regarding the value of publicly accessible ChatGPT as a patient resource for abdominal malignancies. Providers should be prepared to effectively counsel patients to identify their educational attainment level when using ChatGPT to mitigate readability challenges.CancerAccessCare/ManagementAdvocacy -
Outcomes of Radiotherapy With or Without Dose Escalation to Lymph Node Metastases Detected by PET PSMA or Conventional Imaging in Node-Positive Prostate Cancer: A Real-World Multicenter Propensity Score-Matched (PRIMENOD) Analysis.5 days agoTo evaluate the impact of PSMA PET versus conventional imaging for staging, and the effect of dose escalation (DE) to metastatic lymph nodes in cN1 prostate cancer patients treated with EBRT and ADT.
A retrospective multicenter analysis included 197 propensity score-matched patients (77 staged with PSMA PET, 120 with conventional imaging) treated with EBRT and ADT, with or without DE to lymph node metastases. Matching criteria were T stage, nodal involvement, imaging modality, Gleason score, and ADT duration. Primary endpoint was metastasis-free survival (MFS); secondary endpoints included overall survival (OS), locoregional control (LRC), and toxicity.
Median follow-up was 42 months (IQR: 25-59). Median EQD2 (alpha/beta=1.5) to elective nodes was 46 Gy, and to metastatic nodes, 66 Gy (PSMA PET) and 63 Gy (conventional imaging). The 3-year MFS was 80.5% (95% CI: 71.3-90.8%) for PSMA PET and 77.2% (95% CI: 69.5-85.8%) for conventional imaging; 5-year MFS was 59.3% versus 65.8% (P=0.57). OS at 5 years was 82.2% (PSMA PET) and 77.4% (conventional imaging) (P=0.72). On multivariable analysis, ISUP grade group 3-5 predicted earlier metastasis (HR: 4.03, 95% CI: 1.61-10.06; P=0.003); higher prostate dose (EQD2 ≥113 Gy) improved MFS (HR: 0.53, 95% CI: 0.30-0.95; P=0.033); long-term ADT (≥24 mo) improved OS (HR: 0.38, 95% CI: 0.19-0.78; P=0.009). No significant difference in toxicity was observed between groups.
PSMA PET staging and nodal dose escalation >60 Gy were safe but did not improve MFS, OS, or LRC. ISUP grade group 3-5 and higher prostate dose significantly influenced outcomes.CancerAccessCare/ManagementAdvocacy -
Efficacy and Safety of Cosibelimab for Advanced Cutaneous Squamous Cell Carcinoma: An Expert Consensus Panel.5 days agoCutaneous squamous cell carcinoma (cSCC) represents a significant clinical challenge in patients with locally advanced (laCSCC) or metastatic (mCSCC) disease who are not candidates for surgery or radiation. In addition to PD-1 inhibitors, pembrolizumab and cemiplimab, cosibelimab, a PD-L1 inhibitor, has been recently approved by the US Food and Drug Administration (FDA) for laCSCC and mCSCC. Given its recent approval, practical guidance is needed to support clinician decision-making regarding cosibelimab's efficacy and safety.
A comprehensive literature review of PubMed and Google Scholar was completed for studies related to cosibelimab efficacy and safety in la and mCSCC. An expert panel of nine dermatologists with significant expertise in the treatment of cSCC gathered to review the articles and create consensus statements on the role of cosibelimab in managing laCSCC and mCSCC. A modified Delphi process was used to approve each statement, and the strength of recommendation was assigned using the Strength of Recommendation Taxonomy (SORT) criteria.
The literature search produced over 200 articles that met the criteria, and a screening of the studies for relevance resulted in 13 articles. The panel developed six consensus statements, with five unanimously adopted with a strength of "A".
Available data suggests that cosibelimab is an effective treatment for patients with laCSCC and mCSCC who are not candidates for surgery or radiation. Cosibelimab demonstrates a unique and favorable safety profile with no reported grade 4 or 5 immune-related adverse events after more than 2 years of follow-up.CancerAccessCare/Management -
Safety and Efficacy of Aminolevulinic Acid 20% Topical Solution Activated by Blue Light for Facial Cutaneous Squamous Cell Carcinoma in situ.5 days agoSquamous cell carcinoma in situ (isSCC) is an early-stage cutaneous malignancy that requires effective treatment to prevent progression to invasive SCC. Aminolevulinic acid photodynamic therapy (ALA-PDT) is a noninvasive treatment that selectively targets neoplastic cells. This study evaluated the effectiveness, safety, and tolerability of ALA-PDT for the treatment of patients with facial isSCC.
In this single-center, investigator-initiated, open-label study (NCT06159842), adult patients with biopsy-confirmed facial isSCC received 2 treatments with 20% ALA and blue light exposure, administered 28 days (± 3 days) apart. Lesions were excised for histopathological assessment 8 weeks after the second treatment. The primary endpoint was complete histological clearance at the end of treatment (EOT). Secondary outcomes included clinical clearance and tolerability.
A total of 32 patients were enrolled in this study, of whom 30 completed the study. All patients achieved complete histological clearance at EOT. Clinical clearance was observed in all patients prior to excision, with 40% achieving clearance by day 49 and the remainder by day 69. Local skin reactions, including erythema and flaking, were mild and resolved over time. Only 1 patient experienced temporary hyperpigmentation. Pain scores remained low (mean, 2.71/10). Two patients reported adverse events considered unrelated to treatment.
ALA-PDT achieved 100% complete histological and clinical clearance with minimal adverse effects, demonstrating its potential as a safe, effective, and cosmetically favorable alternative to surgical excision for the treatment of facial isSCC. Further studies are needed to assess long-term recurrence rates and broader applications.CancerAccessCare/Management