Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Recurrence

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Disease Attributes

Hematinics

All Drugs and Chemicals

Liver Extracts

Patients receiving a liver transplantation that do NOT develop HCC recurrence after liver transplantation.

Patients receiving a liver transplantation that develop HCC recurrence after liver transplantation.

Determination of serum glycomics pre-transplant using an optimal cutoff based on statistic modeling

HCCRecurrencePrognosticScore

Determination of serum glycomics post-transplant using an optimal cutoff based on statistic modeling

HCCRecurrenceDiagnosticScore

Xavier Verhelst, MD, PhD

Emma Butaye

Liver transplantation (LT) is the only curative option for a selection of patients with hepatocellular carcinoma (HCC) based on clinical selection criteria known as the Milan criteria. Nevertheless, 15% of these patients still show tumour recurrence after LT. In a monocentric pilot study, we have demonstrated that specific changes in N-glycan profiles (measured before LT) occur in HCC patients receiving LT1. These specific changes proved to be strongly associated with the risk of HCC recurrence and overall death after LT, independent of the criteria used for stringent patient selection. Pathophysiologically, it is known that abberations in protein glycosylation are involved in the onset en development of HCC. As such, a prognostic biomarker was developed that can clearly differentiate between patients with and without increased risk of HCC recurrence.

The primary goal of this research study is to set up a prospective, multicentre study in order to validate the prognostic value of this glycomics-based serum biomarker. As such, the risk of tumour recurrence in patients undergoing LT for HCC will be estimated independent from the Milan criteria and the French alpha-fetoprotein model as the current standard. The secondary goal is to explore the potential of serum glycomics as markers of early recurrence after LT for HCC. More specifically, we aim to investigate whether serial glycomics determination at fixed time points after LT could allow early detection of recurrent HCC even before it is visible on conventional imaging. Consequently, a diagnostic biomarker for monitoring early recurrence after LT could be developed with the potential of redirecting treatment strategies already in an early disease stage.

In case the promising data from the pilot study will be confirmed, the prognostic biomarker could be implemented in daily clinical practice leading to optimization of patient selection using a simple blood test before LT. More specifically, this marker could improve organ allocation thus preventing unnessecary treatment toxicity for the patient and reducing the costs of treatment for society. Moreover, it should be emphasized that a patent application was already submitted and accepted in collaboration with TechTranfer of Ghent University (PCT/EP2021/057788-Prognostic markers of disease recurrence in liver transplant recipients with hepatocellular carcinoma).

Serum Glycomics as Prognostic and Diagnostic Biomarkers of Disease Recurrence in Liver Transplant Recipients With Hepatocellular Carcinoma

University Hospital, Antwerp

Universitaire Ziekenhuizen KU Leuven

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

University Hospital, Ghent

Rare Diseases

Neuroendocrine Tumors

Carcinoma, Neuroendocrine

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Gastrointestinal Agents

Herbal and Botanical

Pancrelipase

Pancreatin

Cola

Patients aged at diagnosis from18 to 39 years of age with neuroendocrine neoplasm NEN from Gastroenteropancreatic (GEP) or lung/thymus origin

Patients aged at diagnosis from18 to 39 years of age with carcinoma (without limitations for histologic subtypes) from any primary sites: esophagus, stomach, pancreas, biliary tract, liver, small bowel, colon, rectum, anus and cancer of unknown origin.

Lorenzo Gervaso, MD

Cristina Mazzon

Chiara Alessandra Cella, MD

Luca Mazzarella, MD

Francesca Spada, MD

The objective of the study is to create a common and unique platform for the acquisition of biological samples and, subsequently, the possible identification of predictive and prognostic biomarkers for young adults with gastrointestinal and neuroendocrine cancers.The definition "adolescent and young adults (AYA)" covers a broad group of patients ranging from the upper limit of the paediatric competence to the youngest patients usually considered and treated as adults. However, a well-defined and universally accepted age range is still not established. Young adults with cancer have distinct epidemiological, biological, and clinical characteristics, as well as special medical and psychosocial needs that are often unmet. In consideration of their poor representation in clinical studies, as well as the rarer, albeit increasing, frequency at an epidemiological level, knowledge of the risk factors associated with cancers in young adults is very poor. It is therefore of fundamental importance to focus attention on this specific cohort of patients, in order to describe in ever more detail any specific biomolecular aspects, and make full use of the pharmacological resources currently available.

The definition "adolescent and young adults (AYA)" covers a broad group of patients ranging from the upper limit of the paediatric competence to the youngest patients usually considered and treated as adults. However, a well-defined and universally accepted age range is still not established. In fact, AYA includes patients from 16 to 24 years old according to the Britannic association "Teenage Cancer Trust" or 39 years old for the American National Cancer Institute definitions, respectively. Over the past 30 years, the incidence of cancer in AYA patients has increased globally by approximately 30%, estimating, in 2020 in U.S, 89,500 new cases and 9,270 deaths due to cancer among AYAs. Although the most frequent tumors are germ cell cancer for males and breast and thyroid cancers for female across the world, and confirmed also in Italian registries (https://www.aiom.it/wpcontent/uploads/2020/10/2020_Numeri_Cancro-operatori-web.pdf), malignancies arising from the gastrointestinal tract account all together for around 10% of cases. These are mainly represented by gastric cancer (up to 5%) followed by colorectal, neuroendocrine and hepatobiliary tumors.

Due to the high impact in terms of social impairment, a new and specific classification system based on the International Classification of Diseases for Oncology (ICD-O) and the World Health Organization (WHO) Classification of Tumors series for AYA cancers has been recently presented in order to sharpen the medical needs of this population.

However, AYA cohort remains a major clinical challenge, especially because of its poor representation in clinical trials, which prevent from the possibility to create a profile with specific molecular and etiopathogenetic features. Even though a significant part of these tumors rises from a hereditary basis (often in patients already followed by medical Genetic Unit), in most cases, cancers are sporadic, only partially associated to earlier exposure to carcinogenic factors such as alcohol and smoking, as well as a sedentary lifestyle and poor dietary education. Therefore, many questions remain unsolved regarding carcinogenesis, treatment, prognosis, and, eventually, prevention for family members of these patients.

Moreover, AYAs have a higher risk - even if lower than pediatric patients - to present long-term and late-onset side effects, concerning infertility, sexual disfunction, cardiotoxicity and second tumors. Early predictors biomarkers of these potential consequences are strongly needed. Considering current scarce information regarding how to improve outcomes of young patients affected by GI cancers and neuroendocrine neoplasms, this study aims to shed light on the biological behavior and the unmet needs of this population, by correlating clinical and biological factors to clinical outcomes. The main goal will be, firstly, the creation of a common and unique platform for acquiring biological samples and subsequently, potentially the identification of predictive and prognostic biomarkers.This study comprises both a retrospective and prospective phase. For the retrospective one, AYA patients will be included with GI or NeuroEndocrine (NE) malignancies (histologically confirmed). In the prospective part, when the study will be actively recruiting, clinical and biological data of all AYA patients will be collected and analyzed, according to specific outcomes.

YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs.

YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs (YOUNGSTER).

Prospective and retrospective observational study to analyze the frequency of tumors in young adults (18-49 years) with gastrointestinal and neuroendocrine tumors. Identification of genetic alterations with correlation between somatic and germline alterations.

Describe survival outcomes (overall survival and progression-free survival) according to the main clinical-pathological features and treatment received.

Describe potential toxicities developed as results of treatments according to clinical-pathological, genomic features and treatment received.

European Institute of Oncology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Tumor molecular profiling

Elena Fountzila

We aim to employ targeted DNA NGS to evaluate the prevalence of germline and somatic mutations in cancer predisposing genes, such as BRCA1 and BRCA2, and other HR and DDR genes, including also a few additional clinically relevant genes, in patients with metastatic, locally advanced or high-grade prostate cancer. In addition, we will investigate the prognostic role of these mutations as well as their association with various clinicopathological parameters. This will be the first study investigating the prevalence of germline and somatic pathogenic mutations in Greek patients with prostate cancer.

This study will include formalin-fixed paraffin-embedded tumor tissue (FFPE) from 250 patients with metastatic, recurrent, locally advanced or "intermediate or high risk" (Gleason \>7), operable prostate cancer. FFPE tumor blocks alongside peripheral blood will be retrieved for all patients from Pathology Laboratories. Available FFPE blocks will be subjected to histological review by an experienced pathologist to evaluate H\&E sections for confirmation of diagnosis, histologic type, grade and tumor cell content (TCC%), as well as mark tumor dense areas for manual macro-dissection, prior to DNA extraction, in order to enrich samples for tumor DNA. Clinicopathologic characteristics of patients with prostate cancer will be retrieved from their respective medical records. Diagnosis will be confirmed through pathology reports, which will also provide information about Gleason Score and histological subtype.

In all instances, the collection of patient information will be in compliance with the regulations of the Bioethics committees of participating Hospitals. The study will be conducted in accordance with the principles of the Helsinki Declaration of Human Rights.

Following manual macro-dissection, FFPE tumor tissue material will be processed for DNA extraction, according to standard procedures with the QIAamp DNA Mini Kit (Qiagen GmbH, Hilden, Germany).

Sequencing will be performed at the Laboratory of Molecular Oncology, using an Ion Torrent Proton Sequencer (Life Technologies/Ion Torrent). For the purpose of targeted NGS genotyping of tumor and available matched germline DNA samples, we designed a custom Ampliseq panel to target coding relevant regions of genes involved in homologous recombination (HR), along with several others.

Data retrieval and base calling will be performed on the Torrent Server (v5.8.0.8). Consequently, we will then employ appropriate Ion Reporter Workflows (version 5.10) to automatically annotate single nucleotide variants (SNVs), multiple nucleotide variants (MNVs), small insertions / deletions (INDELs) and copy number variations (CNVs).

Formalin-fixed paraffin-embedded tissue samples and germline DNA

Molecular Profiling in Prostate Cancer

Prognostic and Predictive Value of Tumor Molecular Alterations in Patients With Prostate Cancer

Number of patients with either germline or somatic mutations

Time from diagnosis to the date of death, through the completion of the study

Hellenic Cooperative Oncology Group

Gland and Hormone Related Diseases

Wounds and Injuries

Respiratory Tract (Lung and Bronchial) Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hyperthermia

Fever

Mesothelioma

Mesothelioma, Malignant

Pseudomyxoma Peritonei

Colorectal Neoplasms

Peritoneal Neoplasms

Adenoma

Neoplasms, Mesothelial

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Adenocarcinoma, Mucinous

Neoplasms, Cystic, Mucinous, and Serous

Abdominal Neoplasms

Peritoneal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Malignant Mesothelioma

Patients diagnosed with PSM undergoing CRS with HIPEC.

Analysis of metastatic tissue and blood specimens collected from patients with PSM undergoing CRS-HIPEC. CRS: Removal of all macroscopically detectable tumor.

HIPEC: Instillation of heated chemotherapy in the abdominal cavity to remove residual cancer disease.

Observational study.

Kjersti Flatmark, MD PhD

Annette Torgunrud Kristensen, PhD

The aim of this study is to identify biomarkers of disease recurrence and prognosis to optimize patient selection for treatment with cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC), and through animal models to explore different treatment strategies for peritoneal surface malignancies (PSM).

The handling of patients with PSM involves multimodal and multidisciplinary treatment strategies such as CRS, the removal of all macroscopically detectable tumor, and HIPEC, instillation of heated chemotherapy in the abdominal cavity to remove residual cancer disease. The treatment is challenging and complex and associated with significant morbidity. Only patients with limited disease will benefit from the treatment, and better methods for patient selection are needed. The project group has a unique opportunity to address key questions because of acquired experience, an exceptional biobank and institutional database and novel animal models established at the Norwegian Radium Hospital.

Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies

Prospective Observational Study of Peritoneal Surface Malignancies (PSM) - Characterization, Models and Treatment Strategies.

Time from surgery until death from any cause

Time from surgery until disease recurrence or death

The Research Council of Norway

Oslo University Hospital

Professor

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neuron-Specific Enolase to Albumin Ratio is higher than 3.2×10-7

Neuron-Specific Enolase to Albumin Ratio is lower than 3.2×10-7

Previous studies have shown that inflammation and nutrition-related factors such as CRP/Alb (C-reactive protein-albumin ratio), PLR (platelet-to-lymphocyte ratio), NLR (neutrophil-to-lymphocyte ratio) can help to assess the prognosis of malignant tumors. This study is the first time to combine NSCLC tumor marker NSE and patient nutrition-related indicators Alb to predict the prognosis of patients, trying to find high sensitivity and specificity for NSCLC prognostic indicators to guide clinical work.

Neuron-Specific Enolase to Albumin Ratio

Sida Qin, MD PhD

Sida Qin

The incidence and mortality rate of lung cancer is the highest in the world. Current studies have found that tumor markers, inflammatory or nutritional indicators have a good predictive value for the prognosis of patients with non-small cell lung cancer (NSCLC). Neuron specific enolase (NSE) and serum albumin (Alb) are important indicators for monitoring tumor progression and nutritional status in lung cancer patients, respectively. Previous studies suggested that the higher the NSE, the worse prognosis of NSCLC patients, while the lower the Alb, the worse the prognosis of patients with malignant tumors. Through a retrospective study, the investigators found that NAR (NSE Alb Ratio) was higher and prognosis was poorer in patients undergoing NSCLC surgery. This is better than the previous assessment indicators PLR (platelet to lymphocyte ratio), NLR (neutrophil to lymphocyte ratio), AGR (albumin to globulin ratio), NAR can better assess prognosis. Therefore, on the basis of the previous retrospective analysis, the optimal NAR cut-off value was calculated according to ROC curve, and the value was grouped into multi-center prospective cohort study, and the relationship between NAR and other clinical indicators was studied by chi-square test. Univariate and multivariate analysis of Cox proportional hazard regression model was used to determine the prognostic factors. Finally, NSCLC patients were stratified according to tumor stage and pathological classification, and the differences of survival time between high NAR group and low NAR group were compared again under different stages and types, and the different stages of NAR in NSCLC patients were further analyzed. The clinical significance of typing. By exploring and validating the relationship between NAR and the prognosis of NSCLC patients, the investigators try to establish a new prognostic index. Obviously, it has important value for clinical application.

NSE/Alb as a Prognostic Biomarker for Lung Cancer

A Prospective Cohort Study on NSE/Alb as a Prognostic Biomarker for Lung Cancer Patients in Multicenter

The time from randomization to death due to any cause. The last follow-up time is usually calculated as the time of death for those who have been lost before death.

Refers to the time from randomization to relapse or death due to disease progression. It is usually the end point after radical surgery. DFS is more difficult to record as an end point than OS because it requires careful follow-up and timely detection of disease recurrence. In this study, as an important prognostic indicator for patients undergoing NSCLC surgery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Serum Glycomics as Prognostic and Diagnostic Biomarkers of Disease Recurrence in Liver Transplant Recipients With Hepatocellular Carcinoma	NCT05866783	Prognostic Biom... Liver Transplan... Diagnostic Biom... Hepatocellular ...	HCCRecurrencePr... HCCRecurrenceDi...	18 Years -	University Hospital, Ghent
Serum Glycomics as Prognostic and Diagnostic Biomarkers of Disease Recurrence in Liver Transplant Recipients With Hepatocellular Carcinoma	NCT05866783	Prognostic Biom... Liver Transplan... Diagnostic Biom... Hepatocellular ...	HCCRecurrencePr... HCCRecurrenceDi...	18 Years -	University Hospital, Ghent
YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs.	NCT06337760	Neuroendocrine ... Adenocarcinoma		18 Years - 39 Years	European Institute of Oncology
Molecular Profiling in Prostate Cancer	NCT04983628	Prostate Cancer... Prostate Cancer... Germline BRCA1 ... Germline BRCA2 ... Mutation	Tumor molecular...	18 Years -	Hellenic Cooperative Oncology Group
Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies	NCT02073500	Pseudomyxoma Pe... Colorectal Carc... Ovarian Carcino... Mesothelioma	Observational s...	18 Years -	Oslo University Hospital
NSE/Alb as a Prognostic Biomarker for Lung Cancer	NCT03724604	Carcinoma, Non-...	Neuron-Specific...	18 Years - 70 Years	First Affiliated Hospital Xi'an Jiaotong University
NSE/Alb as a Prognostic Biomarker for Lung Cancer	NCT03724604	Carcinoma, Non-...	Neuron-Specific...	18 Years - 70 Years	First Affiliated Hospital Xi'an Jiaotong University
NSE/Alb as a Prognostic Biomarker for Lung Cancer	NCT03724604	Carcinoma, Non-...	Neuron-Specific...	18 Years - 70 Years	First Affiliated Hospital Xi'an Jiaotong University

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