Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

Hematologic Diseases

Patients with hematologic malignancies and disorders will be asked to donate part of the samples collected as per clinical practice for the management of their disease for the aims of this study. In addition, patients will be asked to donate one oral swab sample, and urine samples. Collection of these additional samples is a non-invasive procedure with no associated risks for patients. Clinical data (demographics including ethnicity, stage of disease, concise treatment history, cytogenetic reports, and molecular data if available, as routinely performed during diagnosis procedures) will be collected.

clinical data and sample collection

Oriana Nanni, Dr

Giorgia Simonetti, Dr

Alessandro Lucchesi, MD

Francesco Lanza, MD

Giulia Tolomelli, MD

Michele Gottardi, MD

Giovanni Martinelli, Prof

Exploratory multicenter, non-interventional, translational, retrospective and prospective study. All patients with a diagnosis of hematologic disorder or malignancy for whom biological samples and clinical data are available may be included in this study, after obtaining informed consent

Hematological malignancies account for approximately 9.5% of newly diagnosed cancers every year and their incidence shows an exponential rise after the age of 40. Since life expectancy is dramatically and continuously increasing worldwide, hematological diseases promise to become a substantial burden for the health care systems of the European society. The management of hematological malignancies is further complicated by the high level of disease heterogeneity in terms of pathogenic and molecular mechanisms. Due to the high level of heterogeneity in terms of cytogenetic, genetic, epigenetic, transcriptional, post-transcriptional and metabolic alterations, an accurate molecular classification of hematological diseases is needed to improve clinical outcomes and patients' management. This is an exploratory multicenter, non-interventional, translational, retrospective and prospective study. All patients with a diagnosis of hematologic disorder or malignancy for whom biological samples and clinical data are available may be included in this study, after obtaining informed consent. The primary objective is to improve our knowledge of the pathogenic mechanisms driving malignant disorders and transformation. The secondary objectives aim to improve diagnosis and stratification of onco-hematological patients and study drug response at preclinical level. After signing informed consent to the study, each patient will donate part of the samples (peripheral blood, bone marrow, biopsies) collected as per routine clinical practice for the management of their disease.

Fresh peripheral blood, bone marrow, urine, bone biopsy, lymph node biopsy, cerebrospinal, ascites, pericardial and pleural fluid. All samples will be collected according to clinical practice. In addition, a saliva sample will be collected.

Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies

To improve our knowledge of the pathogenic mechanisms driving malignant disorders and transformation in different subgroups, defined by molecular, metabolic, proteomic, imaging, preclinical and clinical data integration

To define response/resistance to ex vivo drug treatments;

To identify biomarkers of drug-related toxicity;

To investigate association between biological and molecular features with patient's clinical features.

To investigate recurrence/minimal residual disease patterns after treatments

To identify novel biomarkers for early diagnosis (e.g. predictive of transformation from a pre-malignant to an overt malignant phase) and prognosis.

To improve the diagnostic work-up of haematological disease, thus enlarging the fraction of patients suitable for curative treatments through the identification of circulating and tissue molecular markers.

To provide a technological advancement potentially applicable to the national health system, when properly validated in appropriate patients' subgroups.

Azienda Unità Sanitaria Locale della Romagna

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Eye Diseases

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Carcinoma, Renal Cell

Retinoblastoma

Sarcoma

Endocrine Gland Neoplasms

Neuroblastoma

Kidney Neoplasms

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Retinal Neoplasms

Eye Neoplasms

Eye Diseases, Hereditary

Retinal Diseases

Endocrine System Diseases

Renal Cell Carcinoma

Soft Tissue Sarcoma

Neuroepithelioma

Adult or Pediatric subjects, with any malignancy, pre-malignancy, suspected malignancy, family history of malignancy, or without malignancy undergoing surgery or well visit.

Human samples, specimens and data collected on IRB approved protocols that are now closed

Parent/caregiver of a participating pediatric or adult subject who is being treated for, or who has previously been treated for any form of pediatric cancer.

Donna B Bernstein, R.N.

Rosandra N Kaplan, M.D.

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Background:

- Laboratory investigators who are studying common childhood cancers are interested in developing a tissue repository to collect and store blood, serum, tissue, urine, or tumors of children who have cancer or adults who have common childhood cancers. To develop this repository, additional samples will be collected from children and adults who have been diagnosed with common childhood cancers such as leukemia and tumors of the central nervous system.

Objectives:

- To collect and store blood, serum, tissue, urine, or tumor samples of children who have cancer or adults who have common childhood cancers.

Eligibility:

* Individuals who have been diagnosed with a common childhood cancer (e.g., leukemia) regardless of patient age.
* Children, adolescents, and adults who have been diagnosed with a type of cancer more commonly found in adults.

Design:

* Extra blood, serum (the liquid part of blood), tissue, urine, or tumor samples will be collected from participants at a time when sampling is required for medical care or as part of a research study.
* No additional procedures will be performed for the sole purpose of obtaining additional tumor tissue, aside from what is required for clinical care.

Background:

-Laboratory-based investigations have contributed to an improved understanding of the biology of cancer and to the development of new therapies for pediatric malignancies.

Objectives:

-Systematic Molecular, Genomic, Proteomic, Metabolomic ( Omic ) and other profiling for enrolled subjects.

Eligibility:

Pediatric or Adult subjects of any age with one of the following:

* Diagnosis of any tumor or malignancy, pre-malignant disorder or suspected cancer susceptibility familial syndromes, regardless of age
* Individuals without malignancy undergoing surgery, other treatment or normal well visit.
* Biological relatives of a subject with a pediatric tumor or malignancy or with suspected familial cancer syndrome.
* Patients enrolled in an approved companion protocol
* Blood and/or tissue specimens that have been previously collected and are available for research analysis
* Biospecimens can be collected with minimal additional risk to the subject during sampling or procedures required for routine patient care.

Design:

* This study will allow for the collection of specimens for a Tissue Repository, and for designated sample investigations including systematic molecular, genomic and proteomic (Omic) profiling, and growth factor and cellular profile investigations.
* Testing activities may include:

  * DNA, RNA and protein will be extracted from a section of tumor samples, the remainder will be stored.
  * Germ line DNA and RNA will be extracted from lymphocytes or other normal uninvolved tissue
  * Germ line DNA will be extracted from lymphocytes or other normal uninvolved tissue of the biological relatives of the subject.
  * Xenografts, explant and cell lines established from tumor, pre-malignant and normal samples
  * Tumor samples and samples for circulating tumor cells sent for the establishment of Xenografts and single cell suspension of tumor for drug testing
  * Omics (Genomics and Proteomic) studies will be performed
  * Growth factor and cellular profile investigations of bone marrow-derived cell populations to include quantification of hematopietic progenitor cells (HPCs), endothelial progenitor cells (EPCs), and mesenchymal progenitor cells (MPCs), levels of matrix metalloprotease 2 and 9 (MMP2) and (MMP9), gene expression, growth factor and microvesicle analysis and bone marrow analysis of progenitor cells in blood and tissue.
  * Research tests described in active IRB approved protocols
  * Immune profiling and stromal profiling of blood, tumor, and normal tissues
  * Immune function studies from blood and normal tumor tissues
* Utilizing an oversight committee to oversee the receipt and the distribution of unlinked tissues to other investigators.
* Qualitative methodologies will be used to ascertain knowledge, attitudes, beliefs, and behaviors in 25-35 parents/caregivers at NIH concerning the anticipated use of NGS for diagnosing and directing therapy for pediatric cancer and how incidental findings might be returned.
* Expected accrual 100-150 patients per year.

Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies

.All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

Perform systematic molecular, genomic, proteomic, metabolomics and other high throughput ( Omics ) profiling on tumor and normal tissues

National Cancer Institute (NCI)

Skin and Connective Tissue Diseases

Breast Neoplasms

Congenital Abnormalities

Breast Diseases

Skin Diseases

Participants will be offered:

1. Liquid biopsy of ctDNA and targeted NGS (BRCA1, BRCA2, CHEK2, PALB2, BRIP1, TP53, PTEN, STK11, CDH1, ATM, BARD1, MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, PMS1, PMS2, RAD50, RAD51C, RAD51D, NF1, EPCAM, SMARCA4, CDK12);
2. Whole-genome RRBS

Participants will not be offered targeted NGS or whole-genome RRBS but will receive their usual clinical care

Next Generation Sequencing and Network Analysis will profile genetic and epigenetic abnormalities in blood from patients with BC.

Next Generation Sequencing and Network Analysis

Giuditta Benincasa, PhD

The standard tissue biopsy strategy for cancer detection is not comprehensive enough to profile the whole epi-genomic signatures of breast cancer (BC) and ensure an accurate prognosis and prediction of drug response. Liquid-based assays have the potential to reduce the molecular heterogeneity of BC and a possible utility for improving disease management. In particular, genomic DNA (gDNA) and circulating tumor (ctDNA) can be sequenced for genetic and epigenetic (DNA methylation) profiling of the BC patients to enhance personalized prognosis and prediction of drug therapy. We describe a study protocol for evaluating the clinical utility of the early use of the network-oriented BR(E)2ASTOME algorithm which combine the power of liquid-based assays, advanced epi-genomics platform, and network analysis to identify improve precision medicine and personalized therapy of BC.

The BR(E)2ASTOME study will be performed at the U.O.C. Patologia Molecolare e Clinica, University of Campania "L. Vanvitelli", Naples (Italy) with a long-standing experience in diagnosis and treatment of BC (Refs.). From each study participant, total of 10 mL of pheripheral blood in EDTA tubes will be collected at time of BC diagnosis. Blood-based assays will be performed to obtain genetic and/or epigenetic big data from ct-DNA and gDNA, respectively. A network-oriented algorithm combined with patient-level clinical information will be applied to big data in order to identify clusters of genes (BC-modules) harboring novel genetic mutations, in the NGS-ctDNA BC-group, and differentially methylated regions (DMRs), in the RRBS-gDNA group, with a potential predictive and prognostic role in BC management. In the NGS-ctDNA-RRBS-gDNA group, we will evaluate whether the multi-omics approach is more informative as compared to the single-omic paradigm.

BC patients (males and females) will be randomized to the 2 study arms: ctDNA-NGS + gDNA-RRBS, and standard of care alone. No modifications of intervention assignment will be possible after randomization process of patients. The BR(E)2ASTOME study will provide evidence about the potential clinical utility of early use liquid-based assays and network-oriented biomarkers in prognosis and prediction of drug response in BC management.

Thus, results from BR(E)2ASTOME study will bring to identify not only new molecular mechanisms associated with BC, but also non-invasive biomarkers that can direct towards an early diagnosis, contribute to monitor the cancer progression and the response to therapeutic treatment.

Breast Cancer, Omics, and Precision Medicine

Evaluating the Predictive and Prognostic Power of the Early Breast canceR gEnetic and Epigenetic Abnormalities Through Liquid biopSy and neTwOrk MEdicine Algorithm: the BR(E)2ASTOME Phase II Randomized Controlled Trial

We will evaluate whether the network-oriented BR(E)2ASTOME approach will identify BC modules useful for a better stratification of BC severity.

We will measure:

DNA methylation levels and associations with clinical parameters (survival, hospitalization, all-cause mortality).

We will evaluate potential novel genetic mutations in targeted genes and associations with clinical parameters (survival, rate of hospitalization, all-cause mortality)

We will evaluate whether the network-oriented BR(E)2ASTOME approach will identify BC modules useful for predicting the individual drug response.

We will measure DNA methylation levels, and potential novel genetic mutations, and their association with clinical parameters (poor/good response to drug therapy).

University of Campania "Luigi Vanvitelli"

Principal Investigator

Nutritional and Metabolic Diseases

Metabolic Diseases

50 subjects, adults aged over 18 years, voluntarly participating in this observational study

This is an observational study. The control group (omnivours) will be compared with all otgher groups

This is an observational study

Esther Molina Montes

Noelia M Rodriguez Martin

Mireia Obon Santacana

Pilar Amiano

Esther Molina Montes, Doctor

Esther Molina-Montes

Maria Dolores Ruiz Lopez

Reyes Artacho

Belen Garcia-Villanova

Vito Verardo

Maria Jose Sanchez Perez

Miguel Rodriguez Barranco

Beatriz Sarria

Noelia M Rodriguez-Martin

Justo J Pedroche Jimenez

Ana L Lemus-Conejo

Rocio M Toscano Sanchez

Raquel Cumeras

Noelia M Rodriguez

This projects aims to characterize dietary habits and nutrition quality of pro-vegetarian diets as compared to omnivorous diets. It also aims to stablish gut microbial and metabolit profiles of this dietary pattern, in order to elucidate the role of plant-based diets in cancer prevention and treatment.

Plant-based foods (fruits, vegetables, cereals, nuts and seeds, legumes, and vegetable oils) are the main source of fiber and other bioactive compounds in the diet. Plant-based diets are therefore assumed to prevent mortality and the ocurrence of chronic diseases including cancer. However, evidence on this issue is still scarce, and the mechanisms and drivers of their potential health benefits are also only partially known.

The main objectices of this project are:

1. To develop and validate dietary assessment methods for the vegetarian population
2. To assess dietary habits and consumer beliefs of vegetarians with respect to omnivores, considering different types of vegetarian diets
3. To identify a gut microbiota signature related to plant-based diets from subgroups of subjects following a plant-based diet foods (vegans, lacto-vegetarians, ..., and pro-vegetarians) and omnivorous subjects (non-plant-based diets), from stool metagenomic sequencing.
4. To relate this signature with metabolites present in faeces (related to the presence of certain microbial species) and in urine to improve the predictive capacity of the microbial signature of vegetable diets.
5. Validate the signature using independent study populations, and including colorectal and breast cancer survivors as another study target.

Pro-Vegetarian Diets, Microbial/Metabolite Profiles and Cancer

Characterizacion of Pro-VEgetarian Diets: Diet Quality and Nutrition, MIcrobial/Metabolite Profiles and Implications in CAncer (MIVECA Study)

Dietary habits will be taken by an online specific Food Frequency Questionnaire (FFQ) for Spanish population, including novel vegetarian foods to evaluate vegetarian food consumption. The data analysis will be taken at baseline outcome.

To validated dietary assessment method, two 24-Hour-Recalls in two non-consecutive days will be used, as well as the analysis of specific vegetarian diet metabolites in urine and stool samples using Ultra performance liquid chromatography - tandem mass spectrometer (UPLC-MS/MS). The data analysis will be taken at baseline. We have estimated that 200 subjects will be sufficient to detect, with a 95% confidence and power of 90%, correlation coefficients greater than rho=0.2.

Andalusian School of Public Health

Institut Investigacio Sanitaria Pere Virgili

Institut d'Investigació Biomèdica de Bellvitge

National Research Council, Spain

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

University of Seville

Biodonostia Health Research Institute (Biodonostia HRI)

Universidad de Granada

Professor (Assistant)

Symptoms and General Pathology

Nervous System Diseases

Chronic Disease

Neurodegenerative Diseases

Chronic Graft Versus Host Disease

licia Iacoviello, MD, PhD

This project aims to create a digital platform for personal, clinical, diagnostic and environmental data collection, management and analysis of patients with cardiovascular and neurological disease or cancer admitted to the Neuromed Group clinics, associated with a biobanks of biological fluids and human tissues and a biotechnological platform for "omics" analysis, to encourage personalized, preventative and predictive care.

There is a need for a change of vision in health care that could become a key innovation point for digital medicine in the future, a sort of Copernican revolution: the starting point is no longer the disease, but the patient around whom pathologies and risk factors rotate, not as distinct and uniquely defined entities, but as communicating and interconnected possibilities that define their form only in relation to the individual, his genome, his personality, his habits of life and the environment in which he lives. From these interactions, a personalized, dynamic, integrated, and continuous diagnostic and therapeutic pathway is created that accompanies the person not only in the stage of the disease but also in the previous and subsequent phases, becoming a way of life oriented towards the health of the person rather than a way to cure a disease.

An Integrated Health Life Platform enables you to develop an interactive healthcare health model among all actors who manage the health of the person, healthcare professionals in the area, and hospitals, caregivers, and community through the integration of remote monitoring of data with A virtual community.

The platform is thought not as a pure aggregation of data, but as a digital hub centered on the patient, with his (clinical and personal) data, but also the environment in which he lives, his behaviors, accessibility to services and The relationships that come to them and from them. The platform aims to effectively integrate self management, personalization of the path, and co-production of health, demonstrating that these three key dimensions of care are mutually reinforcing.

The residual portion of biological withdrawals and materials normally used for the patient's therapeutic diagnostic route ( blood, urine, any fragments of biopsy tissue, surgical finds, umbilical cord, placenta sections, cephalorachidian fluid etc). In order to carry out any genetic-molecular investigations, DNA and DNA from these biological fluids and tissues will be extracted.

Neuromed- Integrated Health Life Platform and Biobank

submission of a research proposal form to be approved by the Moli-sani scientific committee and signature of a research agreement.

A repository of biological samples, "Neurobiobank", from patients who will join the project, will be organised at the biotechnology park of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Neuromed of Pozzilli under the responsibility of the experienced staff at the Department of Epidemiology and Prevention.

Analytical tools will be developped for integrating structured and unstructured patients data sets and derive actionable information from their observed interrelationships.

Measure of genomic, epigenetic and proteomic fingerprint of recruited patients

Identification of patterns within the health data that correlate with disease or wellness and create personalised pathway of prevention and care.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies	NCT04298892	Haematologic Di... Haematological ...	clinical data a...	18 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies	NCT01109394	Sarcoma Endocrine Tumor... Neuroblastoma Retinoblastoma Renal Cancer		4 Weeks -	National Institutes of Health Clinical Center (CC)
Breast Cancer, Omics, and Precision Medicine	NCT04996836	Breast Cancer	Next Generation...	18 Years -	University of Campania "Luigi Vanvitelli"
Pro-Vegetarian Diets, Microbial/Metabolite Profiles and Cancer	NCT05621122	Dietary Habits Food Habits Nutrition, Heal... Cancer Metabolic Disea...	This is an obse...	18 Years -	Universidad de Granada
Breast Cancer, Omics, and Precision Medicine	NCT04996836	Breast Cancer	Next Generation...	18 Years -	University of Campania "Luigi Vanvitelli"
Neuromed- Integrated Health Life Platform and Biobank	NCT03279991	Cardiovascular ... Neuro-Degenerat... Cancer Pregnancy		19 Years -	Neuromed IRCCS
Pro-Vegetarian Diets, Microbial/Metabolite Profiles and Cancer	NCT05621122	Dietary Habits Food Habits Nutrition, Heal... Cancer Metabolic Disea...	This is an obse...	18 Years -	Universidad de Granada
Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies	NCT04298892	Haematologic Di... Haematological ...	clinical data a...	18 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Spots Global Cancer Trial Database for omics

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

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