Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Stomach Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Procedure/Surgery: Surgery: Spleen-preservation

Surgery: Splenectomy

Surgery: Spleen-preservation

Mitsuru Sasako, MD, PhD

The purpose of this study is to evaluate the role of splenectomy in potentially curative total gastrectomy for proximal gastric carcinoma in terms of survival benefit and post-operative morbidity.

European clinical trials of gastrectomy showed that splenectomy is an important risk factor for post-operative morbidity and mortality. Retrospective comparisons suggested that splenectomy is associated with poor long term survival. However, Japanese studies revealed that 20 - 30 % of patients with non-early carcinoma in the proximal stomach have nodal metastasis in the splenic hilum and therefore, pancreas-preserving splenectomy is part of the standard operation in specialized centers where splenectomy is not considered a risk factor for operative mortality. There have been no prospective randomized trials to evaluate the survival benefit of splenectomy in total gastrectomy for proximal gastric cancer.

Comparison: Total gastrectomy with pancreas-preserving splenectomy versus total gastrectomy without splenectomy

GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110

Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110

Ministry of Health, Labour and Welfare, Japan

Haruhiko Fukuda

JCOG Data Center

Extent od surgical resection

Marek Sierżęga, MD, PhD

The goal of this observational study is to assess whether the postoperative course and survival of patients subject to multivisceral resections for locally advanced gastric cancer (cT4b) were affected by the extent of surgery. An electronic database of 1476 patients with non-metastatic gastric cancer treated between January 1996 and December 2020 will be reviewed. The main questions it aims to answer are:

* Does splenectomy, distal pancreatectomy or partial colectomy affect postoperative complications
* What factors affect prognosis of patients with locally advanced gastric cancer

Multivisceral Resections for Locally Advanced Gastric Cancer

Type and severity of complications graded by Clavien-Dindo scoring system (from 0 to 5, higher scores mean worse outcome)

Jagiellonian University

Professor

Symptoms and General Pathology

Blood and Lymph Conditions

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Immune System Diseases

Heart and Blood Diseases

Syndrome

Preleukemia

Myelodysplastic Syndromes

Cytopenia

Anemia

Thrombocytopenia

Respiratory Tract Infections

Neutropenia

Purpura, Thrombocytopenic, Idiopathic

Hemolysis

Anemia, Hemolytic

Anemia, Hemolytic, Autoimmune

Purpura

Purpura, Thrombocytopenic

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Blood Platelet Disorders

Agranulocytosis

Leukopenia

Leukocyte Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Thrombotic Microangiopathies

Hemorrhagic Disorders

Autoimmune Diseases

Hemorrhage

Skin Manifestations

Chronic Graft Versus Host Disease

Granulocytopenia

Immune Thrombocytopenia

Idiopathic Thrombocytopenic Purpura

Autoimmune Hemolytic Anemia

Cold Agglutinin Disease

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Hematinics

Coagulants

Rituximab

Luspatercept

Epoetin Alfa

Agglutinins

AIHA patients will be enrolled at diagnosis and stratified according to AIHA type (i.e. warm, cold, mixed, and atypical forms), sampled for peripheral blood for cytokine and NGS studies, and for feces for microbiome studies. If clinically indicated, bone marrow evaluation will be performed and a sample for single cell analysis will be collected. Patients will be followed up to collect treatments, responses, relapses, and complications (particularly thromboses and infections).

ITP patients will be enrolled at diagnosis and sampled for peripheral blood for cytokine and NGS studies, and for feces for microbiome studies. If clinically indicated, bone marrow evaluation will be performed and a sample for single cell analysis will be collected.Patients will be followed up to collect treatments, responses, relapses, and complications (particularly thromboses and infections).

CIN/AIN patients will be enrolled at diagnosis and sampled for peripheral blood for cytokine and NGS studies, and for feces for microbiome studies. If clinically indicated, bone marrow evaluation will be performed and a sample for single cell analysis will be collected.Patients will be followed up to collect treatments, responses, relapses, and complications (particularly infections).

MDS patients will be enrolled at diagnosis and sampled for peripheral blood for cytokine and NGS studies, and to evaluate red cell metabolism. If clinically indicated, bone marrow evaluation will be performed and a sample for single cell analysis will be collected. Patients will be followed up to collect treatments, responses, relapses, and outcome.

evaluation of immunomodulatory cytokines by ELISA kits on peripheral blood samples

cytokine essays

evaluation of somatic mutations commonly associated with myeloid neoplasm and immunodeficiencies by next generation sequencing on peripheral blood samples

evaluation of fecal microbiome on fecal samples

Fecal microbiome

evaluation of recombinant erythropoietin use, safety and efficacy in patients with autoimmune hemolytic anemia according to clinical practice

Erythropoietin

evaluation of cytokine levels, molecular profile and bone marrow microenvironment by single cell analysis in patients treated with luspatercept according to clinical practice

evaluation of TPO-RA use, safety and efficacy in patients with ITP according to clinical practice

Thrombopoietin Receptor Agonist

evaluation of G-CSF use, safety and efficacy in patients with CIN/AIN according to clinical practice

G-CSF

Bruno Fattizzo, MD

The goal of this observational study is to characterize the diagnostic and therapeutic management of autoimmune cytopenias including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic/autoimmune neutropenia.

The main aims to answer are:

* evaluation of traditional and novel diagnostic tools including immunohematology, cytokine essays, bone marrow studies, molecular findings, and fecal microbiome.
* evaluation of type and sequence of the therapies administered, the response rates, and the adverse events.
* evaluation of clinical and laboratory (immunologic, molecular, and morphologic) predictors of outcome.
* evolution of autoimmune cytopenias into myelodysplastic syndromes.
* a subgroup of patients with myelodysplastic syndromes will be included to evaluate the presence of immunologic events, autoimmune activation, and red cell metabolism.

Participants will receive a clinical/laboratory diagnostic workup as per current clinical practice. Furthermore They will be sampled at baseline (peripheral blood and feces for microbiome) and followed up for at least 3 years to evaluate their clinical course, therapeutic management and outcome.

This observational study will characterize the diagnostic and therapeutic management of autoimmune cytopenias including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic/autoimmune neutropenia to evaluate predictors of outcome. Additionally, a subgroup of patients with myelodysplastic syndromes (diagnosed according to current WHO 5th edition 2022) will be included to evaluate the presence of autoimmune activation, and red cell metabolism.

peripheral blood for cytokines and next generation sequencing, bone marrow sample for single cell analysis, fecal sample for microbiome

Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia

Evaluation of the Diagnostic/Therapeutic Course of Patients With Autoimmune Cytopenias (Autoimmune Hemolytic Anemia AIHA, Immune Thrombocytopenia ITP, Chronic Idiopathic/Autoimmune Neutropenia CIN/AIN) and Identification of Predictive and Prognostic Markers.

to define the sensitivity of autoantibody testing in autoimmune cytopenias

to define the specificity of autoantibody testing in autoimmune cytopenias

to define the sensitivity of bone marrow trephine in autoimmune cytopenias

to define response rates to treatment of autoimmune cytopenias and myelodysplastic syndromes

to define somatic mutations in autoimmune cytopenias and myelodysplastic syndromes by NGS

to define pyruvate kinase activity in myelodysplastic syndromes

to define microbiome composition in autoimmune cytopenias and myelodysplastic syndromes

to define bone marrow composition by single cell analysis in autoimmune cytopenias and myelodysplastic syndromes

to define cytokine levels in autoimmune cytopenias and myelodysplastic syndromes by ELISA

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Diseases and Abnormalities at or Before Birth

Lung Diseases

Liver Diseases

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Acute Lung Injury

Pulmonary Atelectasis

Pneumonia

Edema

Pleural Effusion

Pneumothorax

Pancreatic Diseases

Pulmonary Edema

Airway Obstruction

Respiratory Distress Syndrome, Infant

Acute Respiratory Distress Syndrome

Acute Graft Versus Host Disease

Liver Extracts

Marc Bodenstein

The purpose of this study is to determine whether Electrical Impedance Tomography can be used as sensitive and specific predictor in the detection of postoperative pulmonary complications (e.g. pneumonia, bronchitis, acute respiratory distress syndrome, pleural effusion, pneumothorax, pulmonary edema, atelectasis, pulmonary embolism, hypoxemia, hypercapnia, spasms and obstructions of the airway) in patients undergoing epigastric surgery.

* Study cycle:

  1. Check of criteria of inclusion/exclusion
  2. Informed consent
  3. Recording preoperative data via paper case report form
  4. Preoperative EIT measurement
  5. Postoperative EIT measurement
  6. Recording postoperative data via paper case report form

     Patients therapy and any diagnostic investigation during hospital stay (apart from EIT measurement) are performed appropriate to patients individual clinical needs and are independent from participation in this clinical trial. As PPC may result from surgical complications (e.g. intra- /postoperative bleeding, anastomotic leak, infection of the wound, injury of neighboring organs) they are monitored.
* Statistical analysis:

Sample size:

After consultation of Johannes-Gutenberg-University Institute of Medical Biometry and Epidemiology the following procedure was developed: Pre-analysis with 20 patients, then determination of definitive sample size (advised 80 patients).

Population:

Any registered patient is included in population even if no study-treatment was performed. To fulfill Pre-Protocol-Population-criteria EIT-measurement has to be performed before and after elective epigastric surgery and information about PPC must be revealable from patients medical file/records.

* Analysis of efficacy:

  1. Primary objective:

     (A) Incidence of any PPC (postoperative pulmonary complication) until postoperative day 7; Acquisition of PPC might require diagnostic investigation during hospital stay; investigations are only performed appropriate to patients individual clinical needs. As PPC are defined:
     * I: desaturation, increased oxygen demand (data from electronic health record)
     * II: dys-/atelectasis, pleural effusion, pneumothorax, pulmonary vein congestion (data from thoracic x-ray)
     * III: detected respiratory infection/pneumonia, pulmonary edema, Aspiration, non-invasive/CPAP-Ventilation, necessity of pleural drain/of bronchoscopy (data from electronic health record, x-ray)
     * IV: Reintubation (data from electronic health record), ARDS (according to Berlin Definition)

     (B) regional Distribution of Ventilation (Analysis of EIT raw data pre- and postoperative in 4 regions of interest: ventral, mid-ventral, mid-dorsal, dorsal; correlation between PPC and difference in regional Distribution of Ventilation at defined moment)
  2. Secondary objective: post-hoc Analysis (see down Secondary Outcome Measure)

     Average, Median, Quartile, Standard Deviation are detected and shown in Box-plots (type of graphic). Explorative comparison of parameters is effected by t-Test, Mann-Whitney-U-Test, Fisher-Test dependent on normal distribution.
* Quality assurance and data management Design, execution and analyzation of the study is ICH-GCP-conform (Good-Clinical-Practice-Guideline of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). All responsible persons are obliged to good clinical practice. All changes in study protocol are to be authorized by responsible Ethics Committee. The P.I. is responsible for source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms).

Prior to written informed consent all patients are to be informed about character and consequences of the study. With their signature patients permit collection and use of source data. Every patient receives an Identification code for pseudonymization of data. Analyzation and publication of data is effected anonymously only. Data collection is mainly provided in an electronic data base, besides in a paper-based Case Report Form. All electronic and paper-based data and archived in our Clinical Research Center and are accessible for authorized persons (Monitor, Auditor). The study protocol does not provide audits.

Amendment after Pre-analysis:

We conducted a preliminary study of 23 patients for sample size calculation, aligned with the goal of predicting probability of relevant PPC. Power calculation was based on the assumption that 50 % of patients would develop relevant PPC. We performed a power analysis using the Wilcoxon test. The assumption was that AUC of EIT-parameters for distinguishing PPC-affected patients from non-affected patients would be at least 0.65. In order to demonstrate that AUC is indeed above 0.5, a Wilcoxon test can be applied. AUC=0.65 translates into P(X\<Y)=0.65. To demonstrate this at the 5%-significance level with a power of 80%, 116 patients are needed. Considering that approximately 10% of patients may not be evaluable, a total sample size of 130 patients was determined. Interim analysis revealed, that incidence of relevant PPC in the study cohort was lower than assumed in sample size calculation. Therefore a higher sample size was necessary than expected. Furthermore, recruiting was slow. We therefore switched from a confirmatory to a descriptive approach.

Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography

Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography in Intensive Care Patients Undergoing Epigastric Surgery

Comparison of the changed regional ventilation partition to the occurence of postoperative pulmonary complications =\> calculation of sensitivity and specifity of the primary outcome measure to predict PPC. Statistical analysis: receiver operating characteristic (ROC curve).

Sensitivity and specifiy for appearance of PPC (Postoperative Pulmonary Complications) within Postoperative Day 1-7.

Statistical analysis: Sensitivity, Specificity, ROC-curve

Correlation of pre-existing pathologic pulmonary conditions with specific postoperative changes in regional distribution of lung ventilation and perfusion assessed by EIT Statistical analysis: Sensitivity, Specificity, ROC-curve

Appearance of all different forms of PPC within Postoperative Day 1-7 and relation to postoperative EIT-measure (ROI analysis in 8 pulmonary ROIs).

Statistical analysis: Sensitivity, Specificity, ROC-curve

Sensitivity and specifity of postoperative EIT-measure for mortality. Statistical analysis: Sensitivity, Specificity, ROC-curve

Sensitivity and specifity of postoperative EIT-measure for time of intensive care therapy.

Statistical analysis: Sensitivity, Specificity, ROC-curve

Sensitivity and specifity of postoperative EIT-measure for Ventilator-obligatory-free days.

Statistical analysis: Sensitivity, Specificity, ROC-curve

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110	NCT00112099	Gastric Neoplas...	Surgery: Splene... Surgery: Spleen...	20 Years - 75 Years	Japan Clinical Oncology Group
Multivisceral Resections for Locally Advanced Gastric Cancer	NCT06103435	Gastric Cancer	Extent od surgi...	-	Jagiellonian University
Multivisceral Resections for Locally Advanced Gastric Cancer	NCT06103435	Gastric Cancer	Extent od surgi...	-	Jagiellonian University
Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia	NCT05931718	Autoimmune Hemo... Immune Thromboc... Chronic Idiopat... Autoimmune Neut... Myelodysplastic... Cold Agglutinin...	cytokine essays NGS Fecal microbiom... Erythropoietin Luspatercept Thrombopoietin ... G-CSF	18 Years -	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia	NCT05931718	Autoimmune Hemo... Immune Thromboc... Chronic Idiopat... Autoimmune Neut... Myelodysplastic... Cold Agglutinin...	cytokine essays NGS Fecal microbiom... Erythropoietin Luspatercept Thrombopoietin ... G-CSF	18 Years -	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110	NCT00112099	Gastric Neoplas...	Surgery: Splene... Surgery: Spleen...	20 Years - 75 Years	Japan Clinical Oncology Group
Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography	NCT02337673	Pulmonary Disea... Postoperative R... Malignant Neopl... Liver Diseases Pancreatic Dise...		18 Years -	Johannes Gutenberg University Mainz

Spots Global Cancer Trial Database for splenectomy

Every month we try and update this database with for splenectomy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for splenectomy

Every month we try and update this database with for splenectomy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for splenectomy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.