Blood and Lymph Conditions

All Conditions

Hematologic Diseases

Data collection and treatment according to guidelines of standard of medical evaluation and care. No investigational treatments or procedures will be administered on this protocol.

Georg Aue, M.D.

Background:

Researchers seek ways to study people s medical problems in order to teach and further general knowledge. The ability to assess and treat people with a wide range of diseases is critical to training people to be good doctors. It is also needed to keep medical staff up to date. In this study, researchers want to study the course of some illnesses to learn more about them. To do this, they will collect and review people s medical records. In some cases, they may also provide treatment.

Objective:

To collect data that may be used to help researchers create ideas for future research.

Eligibility:

People age 2 and older who have or are suspected to have a medical condition for which they have been referred to NIH s National Heart, Lung, and Blood Institute, as well as stem cell donors

Design:

Participants may be screened with a review of the following:

Medical records

Scans and images

Other existing samples and reports.

Participants medical data will be collected from the standard care they receive. This includes their routine blood and urine tests, X-rays and scans, and other tests to diagnose or follow their medical condition. Data will also be collected from the treatments they may receive. For stem cell donors, data from apheresis procedures will be collected. Demographic data will also be collected.

All of the data will be kept in the medical records or on secure network drives.

Some participants may need to be treated for their medical condition. If so, they will sign a separate consent form for that treatment.

Participation lasts up to 2 years.

This protocol is designed to provide a repository of information to allow for hypothesis generation in future research. This information will be drawn from standard medical care/procedures and follow up of patients and healthy volunteers, including transplant donors, who are not currently receiving therapy on an active NHLBI research protocol. It allows investigation into the problems of these patients for the purpose of teaching and furthering general knowledge. The ability to evaluate and treat patients with a wide variety of diseases is critical to maintaining our accreditation with the hematology-oncology, cardiology, and pulmonary fellowship programs and training our fellows to be competent physicians, as well as for keeping all staff, including senior staff, up-to-date and familiar with the evaluation and treatment of patients with a wide spectrum of diseases. Periodic follow-up and treatment of patients previously entered on NHLBI protocols in order to monitor the long-term course of the underlying disease and the consequences of experimental treatments is also required for fellowship training, and for maintenance of good referral relationships with patients and their physicians. This study also allows for standard apheresis procedures for transplant donors and for care of volunteers who may present with a treatable condition.

Data Collection of Standard Care and Evaluation of NHLBI Patients and Donors

To provide a repository of information on enrolled participants to allow for hypothesis generation in future research

To add value to the NHLBI training program by providing consult, treatment, diagnostic tests, and medical follow-up of participants

National Heart, Lung, and Blood Institute (NHLBI)

Nervous System Diseases

Immune System Diseases

Symptoms and General Pathology

Eye Diseases

Infections

Neoplasms

Rare Diseases

Multiple Sclerosis

Sclerosis

Syndrome

Neuromyelitis Optica

Neuritis

Optic Neuritis

Encephalomyelitis

Myelitis

Myelitis, Transverse

Demyelinating Diseases

Encephalomyelitis, Acute Disseminated

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Optic Nerve Diseases

Cranial Nerve Diseases

Peripheral Nervous System Diseases

Neuromuscular Diseases

Communicable Diseases

Central Nervous System Infections

Central Nervous System Diseases

Neuroinflammatory Diseases

Spinal Cord Diseases

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Nervous System Neoplasms

Neurodegenerative Diseases

Leukoencephalopathies

Brain Diseases

Post-Infectious Disorders

Chronic Disease

Disease Attributes

Acute Graft Versus Host Disease

Neuromyelitis Optica Spectrum Disorder

Transverse Myelitis

Acute Disseminated Encephalomyelitis

Chronic Graft Versus Host Disease

Benjamin Greenberg, M.D., M.H.S.

To establish a large, longitudinal collection of high quality samples and data from subjects with MS, selected other demyelinating diseases (Transverse Myelitis (TM), Neuromyelitis Optica (NMO) or Devic's, Acute Disseminated Encephalomyelitis (ADEM), and Optic Neuritis (ON)), and related and unrelated unaffected controls. Samples and data will be available as a shared resource to scientists researching the causes, sub-types, and biomarkers of MS and related demyelinating diseases.

Biobank For MS And Other Demyelinating Diseases

Large-scale, Multi-disciplinary Sample and Data Repository for Multiple Sclerosis and Related Demyelinating Diseases

Accelerated Cure Project for Multiple Sclerosis

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Recurrence

Aggression

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Dementia

Aberrant Motor Behavior in Dementia

Behavioral Symptoms

Patients who underwent MRI with confirmed pathology data (either biopsy or prostatectomy)

Magnetic Resonance Imaging

Daniele Regge, MD

Simone Mazzetti, PhD

Daniele Regge

Manolis Tsiknakis

Nickolas Papanikolau

Kostantinos Marias

In Europe, prostate cancer (PCa) is the second most frequent type of cancer in men and the third most lethal. Current clinical practices, often leading to overdiagnosis and overtreatment of indolent tumors, suffer from lack of precision calling for advanced AI models to go beyond SoA by deciphering non-intuitive, high-level medical image patterns and increase performance in discriminating indolent from aggressive disease, early predicting recurrence and detecting metastases or predicting effectiveness of therapies. To date efforts are fragmented, based on single-institution, size-limited and vendorspecific datasets while available PCa public datasets (e.g. US TCIA) are only few hundred cases making model generalizability impossible.

The ProCAncer-I project brings together 20 partners, including PCa centers of reference, world leaders in AI and innovative SMEs, with recognized expertise in their respective domains, with the objective to design, develop and sustain a cloud based, secure European Image Infrastructure with tools and services for data handling. The platform hosts the largest collection of PCa multi-parametric (mp)MRI, anonymized image data worldwide (\>17,000 cases), based on data donorship, in line with EU legislation (GDPR). Robust AI models are developed, based on novel ensemble learning methodologies, leading to vendor-specific and -neutral AI models for addressing 8 PCa clinical scenarios.

To accelerate clinical translation of PCa AI models, we focus on improving the trust of the solutions with respect to fairness, safety, explainability and reproducibility. Metrics to monitor model performance and a causal explainability functionality are developed to further increase clinical trust and inform on possible failures and errors. A roadmap for AI models certification is defined, interacting with regulatory authorities, thus contributing to a European regulatory roadmap for validating the effectiveness of AI-based models for clinical decision making.

An AI Platform Integrating Imaging Data and Models, Supporting Precision Care Through Prostate Cancer's Continuum

Fundacao Champalimaud

Stichting Katholieke Universiteit

Fundacion Para La Investigacion Hospital La Fe

University of Pisa

Institut Paoli-Calmettes

Hacettepe University

FUNDACIO INSTITUT D'INVESTIGACIO BIOMEDICA DE GIRONA DOCTOR JOSEP TRUETA

João Carlos Costa - Diagnóstico por Imagem, S.A.

National Cancer Institute (NCI)

General Anti-Cancer and Oncological Hospital of Athens St. Savvas

Royal Marsden NHS Foundation Trust

QS INSTITUTO DE INVESTIGACION E INNOVACION SL

IDRYMA TECHNOLOGIAS KAI EREVNAS

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

THE GENERAL HOSPITAL CORPORATION

BIOTRONICS 3D LIMITED

ADVANTIS MEDICAL IMAGING SINGLE MEMBER PC

QUIBIM SOCIEDAD LIMITADA

UNIVERSITAT WIEN

Fondazione del Piemonte per l'Oncologia

Gland and Hormone Related Diseases

Neoplasms, Germ Cell and Embryonal

Testicular Neoplasms

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Germ Cells Tumors

Nonseminomatous Germ Cell Tumor

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Single Group Assignment: Subjects with Nonseminomatous Germ Cell Tumors who meet eligibility criteria for cellular therapy.

The cellular product consists of ATLCAR.CD30 cells will be administered via intravenous injection, over 5 - 10 minutes after lymphodepletion. The expected volume will be 1 - 50 mL, the prescribed dose will be 2 × 108 CAR-T cells per meter square and the maximum dose will be 5 × 108 CAR-T cells per meter square.

ATLCAR.CD30 Cells

Two to 14 days prior to the initial ATLCAR.CD30 infusion, subjects will receive a lymphodepletion regimen that includes 300 mg per square meter of intravenous cyclophosphamide.

Cyclophosphamid

Two to 14 days prior to the initial ATLCAR.CD30 infusion, subjects will receive a lymphodepletion regimen that includes daily 30 mg per square meter of intravenous fludarabine infusion for 3 days.

Catherine Cheng

Caroline Babinec

Matthew Milowsky, MD

Matthew I Milowsky

This is a phase 2 research study that enrolls adult subjects with Nonseminomatous Germ Cell Tumors (NSGCT). The purpose of this study is to create a repository and explore the presence of modified T cells in the subject's plasma or tumors.

This study collects biospecimens (such as tumor tissue, blood, and modified T cells) that can be used in future research studies. The collected specimens can help to examine whether the modified T cells are present in the body and tumor. If the modified T cells are present in the body, and how long they last. They also will use the specimen to identify ways to improve treatment options for a future cancer patient.

Research with blood, tissue, or body fluids (specimens) can help researchers understand how the human body works. Sometimes researchers collect and store specimens and use them for different kinds of research or share them with other scientists; this is called a specimen repository or "biobank." Research with biospecimens might help to introduce new tests to find diseases or new ways to treat diseases.

The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are proteins that protect the body from disease caused by bacteria or toxic substances. Antibodies work by binding those bacteria or substances, which stops them from growing and causing bad effects. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected. Both antibodies and T cells have been used to treat patients with cancers. They both have shown promise, but neither alone has been sufficient to cure most patients. This study is designed to combine both T cells and antibodies to create a more effective treatment called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD30 antigen (ATLCAR.CD30) administration.

Prior trials have shown the safety of ATLCAR.CD30 product was administered to subjects with lymphomas. This study was planned based on the safety and efficacy data from previous studies (NCT02690545 and NCT02917083).

CD30 CAR for CD30+ NSGCT

Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Patients With CD30+ Nonseminomatous Germ Cell Tumors (NSGCT)

ORR - RECIST will be assessed per RECIST v1.1. criteria which define Complete Response (CR) as the disappearance of all target lesions, pathological lymph node (LN) \<10mm, and normalization of serum tumor markers; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions serum tumor markers (AFP and β-hCG) should be stable or decreasing. ; and Overall Response Rate (ORR) = CR + PR/total number of subjects.

ORR -irRECIST will be assessed per irRECIST criteria which defines complete response (irCR), the disappearance of all lesions, no new lesions, lymph nodes \< 10 mm in short axis; partial response (irPR), ≥30% decrease in the sum of target lesions and non-target lesions are irNN; Stable response (irSD), not meeting criteria for irCR, irPR, or irPD; Progressive Disease (irPD), ≥20% increase in tumor burden and minimum 5 mm absolute increase in compared to nadir; for no new non-target or (irNN) and where irPR or irPD are confirmed by a repeat, consecutive assessment.

BORR will be defined as the best response recorded after the administration of the cell therapy to the date of disease progression per modified RECIST 1.1, or death as a result of any cause.

PFS will be defined per modified RECIST 1.1 criteria. PFS is defined from the day of ATLCAR.CD30 infusion to relapse (in patients with a documented complete response at the time of cell infusion) or progression (in patients without a complete response at the time of cell infusion), or death as a result of any cause per modified RECIST 1.1 criteria classification.

Median PFS is defined from the day of initial lymphodepletion administration of the first ATLCAR.CD30 product infusion to the date of disease progression per modified RECIST 1.1 criteria or death as a result of any cause.

DOR will be defined as the time from documentation of PR or better to PD as defined by modified RECIST 1.1 criteria. Progressive Disease (PD) - At least a 20% increase in the sum of the longest diameter (LD) of the target lesions, a relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm or the appearance of one or more new lesion or unequivocal progression of non-target or non-measurable lesions (e.g. worsening bone pain requiring radiation or significant increase in pain medications) or increase ≥ 50% in AFP or β-hCG.

The percentage of subjects who have an improvement in their response per modified RECIST 1.1.

Adverse Events CTCAE will be classified and graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

Cytokine Release Syndrome (CRS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading. Grade 1 - Mild (Symptomatic Management): Fever ≥38oC, No hypotension, No hypoxia, Grade 2 - Moderate (Moderate Intervention): Fever ≥38oC, Hypotension not requiring vasopressors, Hypoxia requiring low-flow nasal cannula (≤6 L/minute) or blow-by, Grade 3 - Severe (Aggressive Intervention): Fever ≥38oC , Hypotension requiring a vasopressor with or without vasopressin, Hypoxia requiring high-flow nasal cannula (\>6 L/minute), facemask, nonrebreather mask, or Venturi mask, Grade 4 - Life-threatening (Life-sustaining intervention): Fever ≥38oC, Hypotension requiring multiple vasopressors (excluding vasopressin), Hypoxia requiring positive pressure (e.g., continuous positive airway pressure (CPAP), BiPAP, intubation, mechanical ventilation), Grade 5 - Death: Death.

Immune effector cell-associated neurotoxicity syndrome (ICANS) symptoms will be graded according to the criteria outlined in the protocol on a scale from 1 (mild) to 4 (critical). Cytokine release syndrome (CRS) will be graded according to criteria outlined in the protocol on a scale from 1 (mild) to grade 5 (death).

Overall survival will be defined from the day of initial lymphodepletion for the first administration ATLCAR.CD30 cells to date of death.

Persistence and expansion of ATLCAR.CD30 in peripheral blood will be determined by quantitative polymerase chain reaction (qPCR) and flow cytometry in the sample of peripheral blood.

University Cancer Research Fund at Lineberger Comprehensive Cancer Center

UNC Lineberger Comprehensive Cancer Center

Patients treated at NCI with available tissue samples.

Paula A Carter, R.N.

William D Figg, Pharm.D.

BACKGROUND:

Cancer of any type is a serious disease and despite all the progress made from past research, there is still much that is poorly understood at the molecular level. Recent advances in biomedical technology platforms have emerged as critical tools for accelerating personalized medicine. The collection of human tissue specimens has been an invaluable resource for conducting translational cancer research using these developing technologies. The ultimate goal is to understand the molecular indicators of cancer development and progression. While it is ideal to be able to study clinical samples, specifically tissue biopsies, they are however precious and are often difficult to obtain in sufficient quantities or numbers to conduct proteomic or molecular profiling studies. There exists, however, a vast archive of pathologically characterized clinical samples in the form of formalin-fixed paraffin-embedded tissue blocks. The preservation of these tissue blocks and/or slides for long-term (years) storage is an important asset that aids in translational and clinical research. This protocol will describe the procedures for receiving, labeling and storing paraffin-embedded tissue blocks and/or slides until they are needed for future analysis. When blocks are ready for analysis, the requestor will then follow the IRB protocol specific to that study.

OBJECTIVE:

- To obtain tissue blocks and slides from outside pathology departments for cancer patients being treated at the Medical Oncology Branch (MOB) and Affiliates Center for Cancer Research (CCR), National Cancer Institute (NCI) in order to store them for future studies and analysis (e.g., using molecular technology platforms).

ELIGIBILITY:

- Patients suspected of having, or with biopsy proof of malignant disease will be evaluated in the Medical Oncology Branch and Affiliates Clinics, NCI.

DESIGN:

* Tissue blocks and slides will be acquired from outside pathology departments and received by the Clinical Pharmacology Program of the MOB/CCR/NCI for coding.
* Bar-coded tissue blocks and slides will then be transferred to the Laboratory of Pathology/CCR/NCI for proper long-term storage.

Background

* Cancer of any type is a serious disease and despite all the progress made from past research, there is still much that is poorly understood at the molecular level.
* Recent advances in biomedical technology platforms have emerged as critical tools for accelerating personalized medicine.
* The collection of human tissue specimens has been an invaluable resource for conducting translational cancer research using these developing technologies.
* The ultimate goal is to understand the molecular indicators of cancer development and progression.
* While it is ideal to be able to study clinical samples, specifically tissue biopsies, they are however precious and are often difficult to obtain in sufficient quantities or numbers to conduct proteomic or molecular profiling studies.
* There exists, however, a vast archive of pathologically characterized clinical samples in the form of formalin-fixed paraffin-embedded tissue blocks.
* The preservation of these tissue blocks and/or slides for long-term (years) storage is an important asset that aids in translational and clinical research.
* This protocol will describe the procedures for receiving, labeling and storing paraffinembedded tissue blocks and/or slides until they are needed for future analysis.
* When blocks are ready for analysis, the requestor will then follow the IRB protocol specific to that study.

Objective

-To obtain tissue blocks and slides from outside pathology departments for cancer patients being treated at the Genitourinary Malignancies Branch (GMB) and Affiliates Center for Cancer Research (CCR), National Cancer Institute (NCI) in order to store them for future studies and analysis (e.g., using molecular technology platforms).

Eligibility

-Patients suspected of having, or with biopsy proof of malignant disease will be evaluated in the Genitourinary Malignancies Branch (GMB) and Affiliates Clinics, NCI.

Design

* This protocol is not a research study.
* Tissue blocks and slides will be acquired from outside pathology departments and received by the Clinical Pharmacology Program of the OCD/CCR/NCI for coding.
* Bar-coded tissue blocks and slides will then be transferred to the Laboratory of Pathology/CCR/NCI for proper long-term storage.

Collection of Tissue Blocks or Slides From Patients With Cancer

.All IPD recorded in the medical record will be shared with intramural investigators upon request.

To obtain tissue blocks and slides from outside pathology departments for cancer patients being treated at the Genitourinary Malignancies Branch (GMB)Medical Oncology Branch (MOB) and Affiliates Center for Cancer Research (CCR), National Cancer Institute (NCI) in order to store them for future studies and analysis (e.g., using molecular technology platforms).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Data Collection of Standard Care and Evaluation of NHLBI Patients and Donors	NCT04450927	Wide Spectrum o... Hematologic Dis...		2 Years - 120 Years	National Institutes of Health Clinical Center (CC)
Biobank For MS And Other Demyelinating Diseases	NCT00445367	Multiple Sclero... Transverse Myel... Neuromyelitis O... Acute Dissemina... Optic Neuritis		-	Accelerated Cure Project for Multiple Sclerosis
An AI Platform Integrating Imaging Data and Models, Supporting Precision Care Through Prostate Cancer's Continuum	NCT05384002	Prostate Cancer Prostate Cancer... Prostate Cancer... Prostate Cancer...	Magnetic Resona...	18 Years - 85 Years	Fondazione del Piemonte per l'Oncologia
CD30 CAR for CD30+ NSGCT	NCT05634785	Germ Cell Tumor Nonseminomatous...	ATLCAR.CD30 Cel... Cyclophosphamid Fludarabine	18 Years -	UNC Lineberger Comprehensive Cancer Center
Biobank For MS And Other Demyelinating Diseases	NCT00445367	Multiple Sclero... Transverse Myel... Neuromyelitis O... Acute Dissemina... Optic Neuritis		-	Accelerated Cure Project for Multiple Sclerosis
Collection of Tissue Blocks or Slides From Patients With Cancer	NCT02810405	Tumor Carcinogens Neoplasm, Benig... Benign Neoplasm... Cancer		18 Years -	National Institutes of Health Clinical Center (CC)
Biobank For MS And Other Demyelinating Diseases	NCT00445367	Multiple Sclero... Transverse Myel... Neuromyelitis O... Acute Dissemina... Optic Neuritis		-	Accelerated Cure Project for Multiple Sclerosis

Spots Global Cancer Trial Database for repository

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Spots Global Cancer Trial Database for repository

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