Neoplasms

All Conditions

Nervous System Diseases

Heart and Blood Diseases

Rare Diseases

Glioblastoma

Brain Neoplasms

Stroke

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

MIRNA is a prospective multi-center observational study designed to explore 762 plasma microRNAs in patients with malignant CNS tumours: 60 primary glioblastoma (GBM), 20 primary CNS lymphomas and 40 brain metastases in an attempt to establish plasma microRNA signatures specific to GBM capable of distinguishing them from malignant non-glial brain tumours. 20 patients with cerebral stroke and 20 healthy volunteers will also participate in the study, and for each patient, a panel of 762 microRNAs will be screened in plasma.

Neuro-oncology faces two challenges: establishing an accurate, rapid diagnosis and having early therapeutic response. This applies particularly to glioblastoma (GBM) since the positive diagnosis is evoked on MRI imaging and the diagnosis of certainty provided by anatomopathology. There are no perfect techniques and there are problems of differential diagnosis in imaging. Sometimes the context does not allow biopsy or excision.

This study is a prospective multi-center observational study designed to be conducted in patients with malignant CNS tumours: primary glioblastoma (60 GBM), primary CNS lymphomas (20 PCNSL), brain metastases (40 BM), in an attempt to establish plasma microRNA signatures characteristic of a tumour process. Patients with cerebral stroke (20 CS) and healthy volunteers (20 HV) will also participate in the study. For each patient, a panel of 762 microRNAs will be screened in plasma.

First, the investigators will focus on the potentially diagnostic nature of the signature, which may prove useful when there are problems of differential diagnosis in imaging or when the context does not permit biopsy or excision. The main objective of the study is to establish a plasma microRNA signature specific to GBM, capable of distinguishing them from malignant non-glial brain tumours (PCNSL and BM). Within the main objective, discrimination will be established between GBM and malignant non-glial brain tumours.

Secondly, the quantitative approach of plasma miRNoma with 752 microRNAs studied in the different patient groups will allow for other objectives:1/ Establish plasma microRNA signatures characteristic of other types of brain tumours; 2/ Identify a plasma microRNA signature characteristic of the cerebral injury component independently of the tumor component with the CS and HV groups; 3/ Identify plasma microRNA signatures characteristic of GBM subtypes in relation to their genomic alterations; 4/ Establish correlations between plasma microRNA expression levels and data collected through multi-modality MRI imaging and anatomopathology.

Plasma and serum samples aliquoted and stored may be used either for re-analysis if necessary for the current study or as part

Establishment of a Signature of Circulating microRNA as a Tool to Aid Diagnosis of Primary Brain Tumors in Adults

QR (relative amount) of each plasma microRNA for GBM and non-glial tumors (PCNSL, BM).

Description of main imaging and anatomopathological characteristics

Assistance Publique - Hôpitaux de Paris

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Lung Neoplasms

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Respiratory Tract Neoplasms

Thoracic Neoplasms

Respiratory Tract Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Giulia Veronesi, MD

Federica Cioffi

This project aims to implement a health prevention program for smokers or former smokers including early detection of lung cancer, cardiovascular disease (CVD) and chronic obstructive pulmonary disease (COPD). The clinical activity is completed by a pre-clinical evaluation of molecular bio-markers of early diagnosis of these diseases, with the aim of strengthening the sensitivity and specificity of the screening program.

The project also includes a cost-effectiveness assessment to validate the feasibility of the program.

Since lung cancer, CVD and COPD are among the deadliest smoking-related pathologies, the program includes actions aimed at raising awareness among primary care physicians, increasing the smoking cessation rate of participating subjects to improve quality of life.

Optimised Lung Cancer Screening to Prevent Cardiovascular and Pulmonary Diseases Coupled With Primary Prevention

Subjects with increased risk for lung cancer, selected through an epidemiological questionnaire, sign the informed consent and their blood is collected. They then undergo LDCT and an interview at the anti-smoking center. CTs presenting with at least one non-calcified nodule are managed according to dedicated diagnostic algorithm. Nodules indicative of lung cancer will be studied with preoperative diagnosis, with surgical resection preferably performed with a minimally invasive approach. Multimodality treatment is indicated in advanced stage of disease. Subjects with normal findings are scheduled for annuals CT scan for two additional years. Cardiovascular risk will be assessed with the use of the atherosclerotic cardiovascular disease (ASCVD) score, recommended by the American College of Cardiology/American Heart Association, integrated with Reynold risk score and CAC score. The CAC score, calculated on LDCT, is used to quantify the presence of calcium through the coronary system.

Ten ml of blood is collected before LDCT, for plasma and white blood cells. For lung cancer patients, blood is collected before treatment, at 1-6-12 months after treatment, to analyse markers for minimal residual disease or early recurrence.

We will perform:

* CTC identification and genomic analysis. Patients are considered CTCs positive based on cytopathology of the isolated cells and detection of characteristic malignant features.
* Evaluation of Serum of PTX3, measured with an original sandwich enzyme-linked immunosorbent assay (ELISA)
* Circulating microRNA profiling. A custom panel of 6 specific microRNAs identified in a previous study on Karolinska cohort and correlating with increase/reduction risk of CVD Mayor adverse cardiovascular events MACE will be tested in 2000 patients.
* IL-2, IL-8, CRP, IL-5 and Eosinophils analyses. Interleukin-2 and-8, C-reactive protein, interleukiine-5 and eosinophils concentrations in blood are measured with ELISA kits.

Cost-benefit analysis of the prevention program. Direct and indirect costs associated with diagnosis and treatment of smoking-related diseases will be compared to those of a control group with disease detected after the appearance of pulmonary symptoms. The incremental cost effectiveness ratio will be evaluated in terms of QUALYS (quality of life adjusted years saved).

Ospedale San Raffaele

Istituto Clinico Humanitas

Musculoskeletal Diseases

Blood and Lymph Conditions

Neoplasm Metastasis

Bone Neoplasms

Bone Marrow Diseases

Neoplastic Processes

Bone Diseases

Hematologic Diseases

Gianluca Giavaresi, MD

The aim of the present study is to identify deregulated miRNAs in oncological patients with bone metastases present within the circulating exosomes and responsible for the biological mechanisms involved in the process of bone metastasis, in order to obtain a panel of biomarkers predictive of this risk.

Through appropriate molecular screening methods a specific panel of significantly deregulated miRNAs will be identified; subsequently bioinformatics analyzes through the use of dedicated databases will be carried out, based on literature data and predicted protein targets in order to identify their potential role in tumor progression, and especially in the onset of bone metastases. Attention, therefore, may be focused on the individual miRNAs identified through individual analysis analyzes of gene expression. These biomarkers could also serve as therapeutic targets, allowing to improve the effectiveness of current therapies and to undertake timely and appropriate therapeutic choices, developed on the basis of the patient's molecular characteristics

MATERIALS AND METHODS: 1) Removal of whole blood from peripheral vein and separation of plasma from enrolled metastatic cancer patients; 2) Isolation of tumor exosomes circulating from the plasma of cancer patients (Kit Invitrogen: Total Exosome Isolation Reagent); 3) Next generation sequencing methods (NGS) will be used to evaluate the expression profiles of miRNAs isolated from circulating tumor exosomes (MiSeq Illumina System); 4) Mass spectrometry methods will be used for the proteome analysis of circulating exosomes isolated from the plasma of cancer patients (Triple TOFF 5600 Plus System AND HPLC analysis of bioactive and biomarker peptides); 5) 3D cultures for the study of cross-talk between circulating tumor exosomes (isolated from the patients' plasma) and bone tissue cells (using commercial cell lines) as part of the metastatic process (Cellec perfusion bioreactor BioteK AG).

Enrollment Procedures: Patients considered eligible will be enrolled in the study, after providing a written informed consent.

Data Collection: Clinical data will be retrieved by patient's source document. A protocol-specific CRF reporting the results of the analyses will be provided. A CRF is required and should be completed for each included subject.

Ethics: The clinical trial protocol and its documents will be sent before initiating the study to the competent Authorities and Ethics Committees of each participating country for its approval. The responsible investigator will ensure that this study is conducted in agreement with either the most updated Declaration of Helsinki and all the international and local laws that apply to clinical trials and to patient protection. The protocol has been written, and the study will be conducted according to the principles of the ICH Harmonized Tripartite Guideline for Good Clinical Practice (ref: http://www.emea.eu.int/pdfs/human/ich/013595en.pdf).

Informed Consent: All patients will be informed, by the investigator, of the aims of the study, the possible risks and benefits that will derive from the study participation. The Investigator must clearly inform that the patient is free to refuse participation in the study and that can withdraw consent at any time and for any reason. They will be informed as to the strict confidentiality of their patient data, but that their medical records may be reviewed for trial purposes by authorized individuals other than their treating physician. The informed consent procedure must conform to the ICH guidelines on Good Clinical Practice. This implies that "the written informed consent form should be signed and personally dated by the patient or by the patient's legally acceptable representative".

The Investigator must also sign the Informed Consent form, and will keep the original at the site and a copy of the original must be handed to the patient.

The competent ethics committee for each Institution participating to the study must validate local informed consent documents before the study can be opened. It will be emphasized that the participation is voluntary and that the patient is allowed to refuse further participation in the study whenever he/she wants. This will not prejudice the patient's subsequent care.

General Principles for Human Biological Material (HBM) collection: Human biological material (HBM) collection involves the collection and storage of biological material, residual biological material or derivatives in compliance with ethical and technical requirements. Biological material (blood samples) will be centralized and stored at Istituto Ortopedico Rizzoli - Dipartimento Rizzoli-Sicilia, Bagheria (Palermo). From here, the biological material will be used and stored according with the sample characteristic and applicable regulation.

Plasma and circulating exosomes obtained from blood will be stored inside sterile containers (falcon, tubes, eppendorf) in a freezer at the temperature of -80 °C at the Istituto Ortopedico Rizzoli -Dipartimento Rizzoli Sicilia.

The following principles apply to storage of HBM: (a) The Istituto Ortopedico Rizzoli will have a designated person responsible for collection and will act as a communication point; (b) The collected HBM should be documented, i.e. the amount remaining and its location. act as a communication point; and (c) The storage and use of biological material will take place in accordance with the standards of good laboratory practice (GLP) and applicable legislation.

Confidentiality: In order to ensure confidentiality of clinical trial data as disposed the national and European applicable regulation, data will be only accessible for the trial Sponsor and its designees, for monitoring/auditing procedures, the Investigator and collaborators, the Ethics Committee of each corresponding site and the Health Authority. Investigator and the Institution will allow access to data and source documentation for monitoring, auditing, Ethic Committee revision and inspections of Health Authority, but maintaining at all times subject personal data confidentiality as specified in the applicable regulation.

The Investigator must guarantee that patient anonymity is kept at all times and their identity must be protected from unauthorized persons and institutions.

All patients included in the study will be identified with a numeric code, so that no identifiable personal data will be collected. The Investigator must have and conserve a patients' inclusion registry where it figures the personal data of the patient: name, surname, address and corresponding identification code into the study, this register will be kept on the Investigator File.

Publication policy and data ownership: The principal investigator of the study is responsible for the final report, of the publication publish all the data collected as described in the protocol and will ensure that the data are reported responsibly and consistently. In particular, the publication of data deriving from the present study will take place independently of the results obtained. The transmission or dissemination of data, through scientific publications and / or presentation at conferences, congresses and seminars, will take place exclusively following the purely statistical processing of the same, or in an absolutely anonymous form. All the study data are owned by the sponsor.

plasma and circulating exosomes, microRNA

Identification and Characterization of Predictive Factors of Onset of Bone Metastases in Cancer Patients

Identification of miRNA isolated from circulating tumor exosomes and their changes will be done through expression profiling studies using Next Generation Sequencing (NGS) during follow-up time points. Molecular characterization will be performed on miRNA samples isolated from circulating tumor exosomes separated from the plasma in order to identify new markers related to tumor progression (bone metastases).

Qualitative and quantitative proteomic analysis of the content of circulating tumor exosomes will be performed by using Triple TOF mass spectrophotometer and variation during follow-up time points wil be measured.

Correlation analyses (correlation coefficients) among plasma levels of circulating tumor exosomes, their content in miRNAs, and clinical parameters related to patient survival and progression of their disease.

In vitro studies with 3D culture model will then allow a more detailed understanding of the cross-talk between tumor exosomes and bone tissue cells (commercial cell lines) within the tumor niche.

Istituto Ortopedico Rizzoli

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Xueqing Yu, M.D. & Ph.D.

In this study, renal cell carcinoma (RCC) related miRNA and the target genes of related miRNA will be examined in order to investigate the role of miRNA in the formation of RCC and look for the biomarker of RCC.

Due to the lack of specific indicators for the early diagnosis of RCC, the RCC patients often have distant metastasis when diagnosed and their five-year survival rate is much low. Therefore, the biological markers of RCC are needed for early detection, early treatment and improvement of the survival rate of RCC patients.

MiRNA and tumor are closely related. MiRNA can control the important cancer-related genes and participate in the tumor cell proliferation, apoptosis, invasion and angiogenesis.

In this study, RCC related miRNA and the target genes of related miRNA will be examined,and the relationship between RCC related miRNA and the RCC pathological types, TNM (tumor-nodes-metastasis) stages and prognosis will be analyzed. The purpose of this study is to investigate the role of miRNA in the formation of RCC and look for the biomarker of RCC.

The tumor tissues and tumor adjacent tissues will be collected when patients receive renal cell carcinoma resection.

The blood and urine will be collected before patients receive operation. And the blood and urine of some healthy volunteers will be collected as the control group.

microRNA Expression in Renal Cell Carcinoma

Sun Yat-sen University

Professor

Digestive System Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

MiR-20a, MiR-21, MiR-106b, MiR-199a, MiR-223

MicroRNA

Rapat Pittayanon

Kanik Sritara

Rapat Pittayanon, MD

The goal of this observational study is to compare specific microRNA levels from the plasma of gastric cancer patients and healthy volunteers to see if there is an upregulated expression in gastric cancer patients.

The main question it aims to answer is:

- Can microRNAs be effectively used as diagnostic biomarkers for gastric cancer?

Participants will be asked for their consent to obtain 5 cc of blood.

5 cc of blood will be obtained from each subject then the plasma portion will be collected.

MicroRNAs From Blood Samples as Biomarkers for Gastric Cancer Detection

MicroRNAs From Blood Samples as Biomarkers for Gastric Cancer Detection: a Diagnostic Study

The different of MiR-20a level between gastric cancer and control group

The different of MiR-21 level between gastric cancer and control group

The different of MiR-106b level between gastric cancer and control group

The different of MiR-199a level between gastric cancer and control group

The different of MiR-223 level between gastric cancer and control group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Establishment of a Signature of Circulating microRNA as a Tool to Aid Diagnosis of Primary Brain Tumors in Adults	NCT03630861	Brain Tumors		50 Years - 75 Years	Assistance Publique - Hôpitaux de Paris
Establishment of a Signature of Circulating microRNA as a Tool to Aid Diagnosis of Primary Brain Tumors in Adults	NCT03630861	Brain Tumors		50 Years - 75 Years	Assistance Publique - Hôpitaux de Paris
Optimised Lung Cancer Screening to Prevent Cardiovascular and Pulmonary Diseases Coupled With Primary Prevention	NCT04315766	Lung Cancer Cardiovascular ... Chronic Obstruc...		55 Years -	Istituto Clinico Humanitas
Identification and Characterization of Predictive Factors of Onset of Bone Metastases in Cancer Patients	NCT03895216	Bone Metastases		18 Years -	Istituto Ortopedico Rizzoli
microRNA Expression in Renal Cell Carcinoma	NCT00743054	Carcinoma, Rena...		18 Years -	Sun Yat-sen University
Identification and Characterization of Predictive Factors of Onset of Bone Metastases in Cancer Patients	NCT03895216	Bone Metastases		18 Years -	Istituto Ortopedico Rizzoli
microRNA Expression in Renal Cell Carcinoma	NCT00743054	Carcinoma, Rena...		18 Years -	Sun Yat-sen University
MicroRNAs From Blood Samples as Biomarkers for Gastric Cancer Detection	NCT05901376	Gastric Cancer MicroRNAs	MicroRNA	18 Years -	King Chulalongkorn Memorial Hospital

Spots Global Cancer Trial Database for micrornas

Every month we try and update this database with for micrornas 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 micrornas

Every month we try and update this database with for micrornas 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 micrornas 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.