Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Immunomodulating Agents

Patients, ≥18 years of age, with newly diagnosed GBM, World Health Organization (WHO) Grade IV, undergoing gross total resection (defined as \>90% of contrast enhancing volume removed on post-operative MRI) and collection of blood, bone marrow, and tumor.

Tumor collection (\> 1cm3): Intraoperatively

Peripheral blood collection:

* Intraoperatively (60mL)
* Post-resection (30mL)
* Post- standard of care treatment (30mL)

Bone marrow aspiration:

* Intraoperatively (10mL)
* Post-resection (5mL)
* Post- standard of care treatment (5mL)

Biorepository

Peter Fecci, M.D., Ph.D.

Beth Mancuso-Mills, M.B.A.

Beth Perry, RN

Claudia E Pamanes, MPH

The main goal of this study is to provide foundational data to drive translational approaches for an entirely novel category of immunotherapy.

The investigators' recent studies show that large numbers of T cells in patients and mice with intracranial tumors are sequestered in bone marrow. This phenomenon mysteriously confines a pool of functional, naïve T cells with anti-tumor capacity to a compartment where they are unable to access tumor, eliciting a mode of T cell dysfunction categorized as "ignorance." The investigators have uncovered that loss of the sphingosine-1-phosphate receptor 1 (S1P1) from the surface of T cells mediates their sequestration in bone marrow, while blocking internalization of S1P1 facilitates stabilization of the receptor on T cells and frees them for anti-tumor activities. As the investigators look to design interventions targeting β-arrestin mediated S1P1 internalization as a novel anti-tumor strategy, they need to better understand variations in sequestration across patients, over time, and with treatment. Assessing these variations and biomarkers that may accompany them will help to establish a target treatment population, as well as the optimal timing for intervention.

Primary Objectives:

1. Assess variations in blood and bone marrow T cell counts as they relate to treatment time-points in patients with glioblastoma (GBM).
2. Assess variations in S1P1 levels and their correlation with blood and bone marrow T cell counts over the course of treatment in patients with GBM

Exploratory Objectives:

1. Assess the associations between tumor size and degree of lymphopenia and bone marrow T cell sequestration observed.
2. Compare The Cancer Genome Atlas (TCGA) subclasses with respect to the degree of lymphopenia and bone marrow T cell sequestration observed at diagnosis.
3. Examine patient plasma, tumor supernatant, and tumor ribonucleic acid (RNA) for markers that are associated with lymphopenia, T cell S1P1 levels, and bone marrow T cell sequestration. Initial candidates will include transforming growth factor-β (TGFβ) 1/2, tumor necrosis factor (TNF), interleukin (IL)-33, IL-6, catecholamines, signal transducer and activator of transcription 3 (STAT3) RNA, and Kruppel-like factor 2 (KLF2) RNA.
4. Compare T cell phenotypes in the blood and bone marrow of patients exhibiting versus not exhibiting T cell lymphopenia or sequestration.
5. Compare differences in tumor-infiltrating lymphocyte numbers and phenotypes between patients with and without lymphopenia / sequestration at diagnosis.
6. Establish baseline β-arrestin 1 and 2 expression in patients and assess variation across individuals.
7. Archive samples for subsequent assessment of β-arrestin recruitment to the cytoplasmic component of T cell S1P1, as well as the capacity to inhibit such recruitment in vitro with candidate small molecules.

1. Tumor collection
2. Peripheral blood sample collection
3. Bone marrow aspiration

Longitudinal Assessment of Marrow and Blood in Patients With Glioblastoma

Assess variations in blood and bone marrow T cell counts as they relate to treatment time-points in patients with glioblastoma.

Assess variations in S1P1 levels and their correlation with blood and bone marrow T cell counts over the course of treatment in patients with glioblastoma.

Duke University

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Blood and Lymph Conditions

Nervous System Diseases

Adenomatous Polyposis Coli

Syndrome

Preleukemia

Myelodysplastic Syndromes

Neurofibromatoses

Neurofibroma

Neurofibroma, Plexiform

Bone Marrow Diseases

Hematologic Diseases

Nerve Sheath Neoplasms

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Polyps

Adenomatous Polyps

Adenoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Intestinal Polyposis

Familial Adenomatous Polyposis

MYH-associated Polyposis

Neurofibromatosis

Adult/pediatric with suspected or confirmed malignancy, family history of malignancy, undergoing surgery with no malignancy; tissues collected previously under CLIA or for research.

Javed Khan, M.D.

Background:

Saliva, blood, tissue, and cancer contain DNA. DNA makes the "instruction book" for the cells in the body. Cancer is caused by changes in DNA that affect cell function. Researchers want to test DNA of people with tumors. They want to look for genetic changes in tumors that could be targets for treatment. Because DNA can change as cancer changes, more testing may be done at different times.

Objectives:

To find the DNA changes in cancer that may help guide treatment. To collect samples and data to be used in future studies.

Eligibility:

People any age with cancer or a pre-cancerous tumor

Design:

* Participants will be screened with a medical history, physical exam, and blood tests. Participants will give a sample of their tumor. This is usually from a previous procedure. Participants will give a saliva or blood sample. They cannot eat, drink, smoke, or chew gum for 30 minutes before giving saliva. They will spit about 1 teaspoon of saliva into a tube.
* Some participants may have a punch biopsy instead. A small instrument will take a small piece of skin.
* Researchers will collect data from participants medical records.
* Participants will answer questions about their family health history. They will also answer questions about their views on the study, including possible unexpected results.
* Extra blood or tissue samples may be taken at other times during the participants' treatment. All samples will be saved in secure ClinOmics freezers to be used in future studies.
* Participants will be told by their doctors if any test results affect their health or their cancer treatment.

Background:

* Laboratory-based investigations have contributed to an improved understanding of the biology of cancer and to the development of new therapies for malignancies.
* Omics investigation may identify novel drivers in the germline or tumor for high risk, relapsed, refractory or rare cancers.
* Omics investigation may identify germline or somatic alterations that are medically actionable and or can enable precision therapy.

Objectives - Primary Objective:

-Identify incidental and secondary findings in germline DNA and actionable somatic mutations for reporting clinical results from a CLIA-certified lab into CRIS medical records.

Eligibility - Adult or Pediatric patients of any age with one of the following:

* Diagnosis of any tumor, malignancy, pre-malignant disorder, or suspected cancer susceptibility familial syndromes, regardless of patient age; OR
* Individuals without history of malignancy who are undergoing surgery; OR
* Individuals without a history of cancer but evidence of an inherited cancer syndrome based on family history and/or other manifestations of a pre-cancerous syndrome (e.g. polyposis, plexiform neurofibromas, myelodysplastic disease); OR
* Patient enrolled in an approved companion protocol.
* Tissue (including tumor, normal, blood, bone marrow, serum, plasma, or other tissues) that has been previously collected under CLIA and maintained in a CLIA lab which is available for CLIA analysis.
* Tissue (including tumor, normal, blood, bone marrow, serum, plasma, or other tissues) that has been previously collected and is available for research analysis.
* Biospecimens can be collected with minimal additional risk to the subject during sampling or procedures required for routine patient care.
* Individual may be undergoing treatment for malignancy, premalignant condition or receiving other care associated with an inherited cancer syndrome.
* Patients may be referred to the Principal Investigator from outside institutions.
* Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent OR
* IRB waiver of the requirement for informed consent for specific types of tissue.

Design:

* This study will allow for the collection of specimens for CLIA reporting of germline and somatic mutations. The study will also collect specimens for a Tissue Repository, and for other investigations as outlined below.
* CLIA testing activities will include

  * DNA extracted from a section of tumor, malignant tissue, blood, or bone marrow samples for somatic mutation sequence analysis
  * Germline DNA extracted from lymphocytes, saliva, skin, or any normal uninvolved tissues for sequence analysis to identify somatic alterations in the cancer and for the reporting of incidental findings of established clinical validity and utility.
* Research activities may include:

  * DNA, RNA and protein Omics analyses from extracted normal and/or tumor tissues; the remainder of the tumor tissue will be stored.
  * Germline DNA and RNA analyses from extracted lymphocytes or other normal uninvolved tissue.
  * T (TCR) or B Cell Receptor sequencing from blood, tumor, or malignant tissue.
  * Establishing Patient-Derived Models such as patient-derived xenografts (PDXs), early-passage in vitro tumor cultures, and organoid cultures, conditionally reprogrammed cells (CRC) lines, explant and cell lines from tumor or normal samples by the NCI Patient-Derived Models Repository (PDMR) at Frederick National Laboratory for Cancer Research or by the OncoGenomics laboratory.
  * Cryopreservation of viable normal (e.g. PBMC) or malignant tissues.
  * Establishment of EBV transformed cell lines from blood for medical research either by Coriell Institute or by investigators on this protocol.
  * Omics (Genomics, Proteomic, Epigenetics, Metabolomics) studies will be performed.
* Expected accrual 50-500 patients per year. Total protocol accrual goal 5,000 patients.

Clinical Sequencing of Cancer and Tissue Repository: OncoGenomics

Clinical Sequencing of Cancer and Tissue Repository: ClinOmics

Sample analysis for identification of biomarkers, drivers and medically actionable targets for clinical management.

Oversight and development of new treatment approaches.

National Cancer Institute (NCI)

Heart and Blood Diseases

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia

Lymphocytosis

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Leukocytosis

Leukocyte Disorders

A subset of 1990 AHS cohort members who are male private pesticide applicators, living and over 50 years of age at the time contact, cancer free, and who completed AHS Phases IIII.

A group of 225 age-, race-, and countymatched, non-AHS controls, who have not lived or worked on a farm as an adult, or held a job applying pesticides.

Jonathan N Hofmann, Ph.D.

Background:

- Multiple myeloma (MM), a type of cancer that affects the white blood cells, is often preceded by a precancerous disorder known as monoclonal gammopathy of undetermined significance (MGUS). Farmers and other agricultural workers have a higher risk of developing MGUS and MM, possibly because of their exposure to certain pesticides. Researchers are interested in studying biological specimens taken from participants in the Agricultural Health Study - specifically, pesticide applicators at least 50 years of age who do not have cancer- to better understand the development of MGUS and MM.

Objectives:

* To collect biological specimens from Agricultural Health Study participants for further research.
* To examine the relationship between pesticide exposure and MGUS/MM.

Eligibility:

- Male pesticide applicators who are over 50 years of age, cancer-free, and participating in the Agricultural Health Study.

Design:

* Two groups of participants will complete the study: a general group and a smaller group of individuals who have been exposed to the pesticide diazinon.
* All participants will receive an initial contact letter with information about the study, followed by a phone call to administer a screening questionnaire and arrange a home visit from a researcher within the next month.
* Participants will receive by mail a urine specimen kit that will be collected at the home visit.
* During the home visit, a study researcher will take blood samples and collect the urine sample, and will administer another questionnaire.
* Participants in the group exposed to diazinon will have three home visits for the study: (1) prior to pesticide exposure, (2) the day after participants stop using diazinon, and (3) about 21 days after the second visit. The first visit will take place in the off-season from January to March; the second and third visits will be conducted between April and August.
* No treatment will be provided as part of this study.

We propose to conduct a molecular epidemiology study with a subset of participants in the Agricultural Health Study (AHS), a prospective cohort of 57,310 licensed pesticide applicators in Iowa and North Carolina. Blood and urine samples will be collected from 1,990 cancer-free male AHS participants over the age of 50. These participants will also be asked to complete a brief interview (approximately 20 minutes) regarding recent exposures and other lifestyle and health characteristics, which will be conducted at the time of the biospecimen collection. Participants in both Iowa and North Carolina will be enrolled and home visits for interviews and sample collection will take place throughout the year between 2010-2014.

The proposed study has two primary objectives. First, we will determine the prevalence and study the etiology of monoclonal gammopathy of undetermined significance (MGUS), which is a precursor biomarker for multiple myeloma. We will compare the prevalence of MGUS in the AHS cohort with the prevalence in two general population-based cohorts ( i.e., Olmsted County and NHANES IID) with well-characterized MGUS prevalence levels. As a result of previous data collection efforts in the AHS, comprehensive information on lifetime occupational exposures and lifestyle factors will be available for the subjects included in this study. We will examine the associations between MGUS and lifetime exposure to specific pesticides within the AHS cohort. We will also evaluate several other biomarkers, including telomere length and global DNA hypomethylation in peripheral blood lymphocytes, for associations with specific pesticides and excess risk of MGUS.

The second objective is to establish a resource with the remaining blood and urine samples collected from the participants in this study. These biospecimens will be used to evaluate the biological plausibility and the mechanism-of-action of associations between pesticides and cancers observed in earlier AHS studies. Many of these pesticides are non-genotoxic and their mechanism of carcinogenesis has not been determined. One such future study involving repository samples will be an investigation of monoclonal B-cell lymphocytosis (MBL), a marker which has been shown to precede chronic lymphocytic leukemia in previous studies. Several pesticides in current widespread use in the AHS have been linked to leukemia. We will determine the prevalence of MBL in the AHS cohort and evaluate potential associations with specific pesticides of interest to better explain the relation between pesticide exposures and leukemia risk.

Specimen Collection for Agricultural Health Study Cohort Pesticide Exposure Study

Study of Biomarkers of Exposure and Effects in Agriculture

To collect biological specimens from Agricultural Health Study participants for further research. To examine the relationship between pesticide exposure and MGUS/MM.

Dermatologic Agents

Coal Tar

Sido Oghenevovwero, MS

Keisha Riser, MBA

Ronan Kelly, MD

The purpose of the Texas Immuno-Oncology Biorepository (TIOB) is to collect and store well-defined and well-annotated serial biospecimens of tissue, blood, urine and stool in a longitudinal manner from cancer patients who are receiving either standard of care surgical interventions and or FDA approved immunotherapeutics across the largest not-for-profit health system in Texas. Comprehensive clinical and radiological data from a diverse population of patients with different racial, social and ethnic backgrounds matched with serial biospecimens over a patients journey with cancer marks the TIOB as a unique research facility.

The goal of establishing the Texas Immuno-Oncology Biorepository (TIOB) is to create a research facility that purposely consents patients to collect, catalog, process, store, and analyze biospecimens with well-annotated clinical/radiological data from patients receiving surgical interventions or immunotherapeutics in our combined clinics throughout Texas. Potential types of studies that will be enabled by this resource will include but are not limited to (a) morphological studies including immunohistochemistry, (b) genomic and molecular analysis, including circulating, cell-free DNA, RNA, as well as extracellular vesicles and their cargo, (c) proteomic analysis involving protein isolation, (d) interrogation of circulating immune cells as well as the underlying tumor immune microenvironment, and (e) single-cell and spatial transcriptomics. Correlation of these studies with clinical, treatment outcome, and demographic information will be possible. Translation of multi-omics technologies will be a key feature of the TIOB and data integration strategies including genomics, epigenomics, transcriptomics, proteomics, radiomics, metabolomics and microbiomics will be possible and offer opportunities to improve our understanding of the complex biological interactions that define cancer.

TIOB will collect tissue, bodily fluids, and blood samples.

The TIOB - Collection of Patients' Biospecimens for Analysis of Immunological and Molecular Biomarkers.

The Texas Immuno-Oncology Biorepository: Collection of Patients' Biospecimens for Analysis of Immunological and Molecular Biomarkers That Predict Benefit/Resistance to Cancer Therapeutics.

Develop a biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and aligned clinical data for development of new diagnostic and therapeutic technology.

Implement release of specimens from biorepository for testing.

Genomic and Molecular analysis including circulating cell free DNA/RNA

Translational Genomics Research Institute

Baylor Research Institute

Blood sample collection

Tumor tissue sample collection

Bryan P Schneider, MD

This is a tissue collection protocol to create an annotated biorepository to support future basic and translational research. The study protocol and consent will request patient permission to allow their specimens to be stored for future use in other laboratory/correlative studies without requiring a separate new consent at a future date. It will include also a retrospective review of all patients who have been seen or treated by the Precision Genomics Clinic (waiver of consent requested). No specific research studies/aims are included directly in this proposal. Use of the samples, data, and other resources (cell lines, etc.) created within this protocol will require review/approval by the majority of the Precision Genomics Investigators and appropriate IRB approval.

Prospective blood and tumor tissue samples will be collected. Retrospective review of patient charts for clinical information will also be done.

Biorepository for Precision Genomics

Collection of Specimens and Clinical Data to Create a Biorepository for Precision Genomics

Blood and tissue sample collection for use in future basic and translational research studies

Indiana University

Clinical Pharmacy Specialist

Nutritional and Metabolic Diseases

Colorectal Neoplasms, Hereditary Nonpolyposis

Rectal Diseases

DNA Repair-Deficiency Disorders

Metabolic Diseases

Herbal and Botanical

Cola

Participants with colorectal or endometrial cancer.

The first-degree relatives of the CRC probands (participants with colorectal cancer).

The relatives of the participants found to have Lynch syndrome.

All participants with CRC or EC will have LS tumor screening (MSI, IHC, methylation if applicable).

LS tumor screening

Next-generation sequencing panel of several genes that increase the risk for hereditary cancers including the LS genes (MLH1, MSH2, MSH6, PMS2, EPCAM), polyposis genes (MUTYH, APC), and others.

The following study participants will have free genetic testing:

* CRC and EC study participants with unmethylated MSI-high (MSI-H) tumors
* CRC and EC study participants with microsatellite stable (MSS) or MSI-low (MSI-L) tumors who have abnormal IHC results and they do not have methylation of the MLH1 promoter
* CRC study participants diagnosed with CRC \<50 years, regardless of tumor studies or family history
* CRC study participants diagnosed with CRC ≥ 50 years with a FDR with CRC or EC OR synchronous or metachronous CRC or EC throughout their life, regardless of tumor studies.

At-risk relatives of the individuals found to have LS are eligible for free single site genetic testing.

Genetic testing

The participants found to have LS or another type of hereditary cancer will have free genetic counseling.

At-risk relatives of the individuals found to have LS are eligible for free genetic counseling.

Genetic Counseling

The biorepository is an optional part of the OCCPI. CRC and EC participants will contribute leftover tumor and blood samples, as well as a saliva sample. FDR of the CRC participants will contribute a saliva sample. The at-risk relatives of those found to have LS will contribute blood and saliva samples.

Questionnaire

Heather Hampel, MS, LGC

The purpose of the Ohio Colorectal Cancer Prevention Initiative (OCCPI) is to reduce morbidity and mortality due to colorectal cancer (CRC) in the state of Ohio. By identifying individuals at high-risk for CRC (genetically predisposed) and providing screening recommendations for cancer risk reduction, the OCCPI will understand how to increase length of life and quality of life for those diagnosed with CRC in Ohio, as well as to better prevent CRC in others in Ohio.

Participants will have free tumor screening for Lynch syndrome, and may be eligible for free genetic testing and free genetic counseling as part of this study.

Lynch Syndrome:

Lynch syndrome (LS), previously known as "hereditary non-polyposis colorectal cancer", is a hereditary cancer syndrome that causes the majority of hereditary CRC and approximately 3% of all CRC. LS significantly increases the risk for an individual to develop CRC during their lifetime. Individuals with LS also have an increased risk to develop extracolonic cancers, including endometrial, gastric, ovarian, upper urinary tract, small bowel, biliary tract, CNS, and certain types of skin cancer. Tumor studies, including microsatellite instability (MSI) testing and immunohistochemical (IHC) analysis, provide information regarding characteristic features of LS-associated tumors and can help target genetic testing. Given the hereditary nature of this syndrome, screening all patients who are newly diagnosed with CRC for LS can identify additional individuals who are at high-risk of developing cancer.

Study Aims:

By developing a CRC research infrastructure within the state of Ohio, the OCCPI will achieve the following specific aims:

* Establish and implement a statewide universal screening protocol for LS.
* Elucidate the prevalence of hereditary CRC in Ohio.
* Provide screening recommendations for high-risk individuals with CRC and their families, as well as local access to genetic counseling.
* Create a CRC biorepository for future research on the etiology of CRC from the leftover samples of the CRC patients, as well as samples from their relatives.

With the successful implementation of the OCCPI, knowledge will be gained that will facilitate the adoption of a universal screening protocol for LS in Ohio and the creation of a statewide CRC biorepository to be used for additional studies on cancer risks, prevention, screening, treatment and survivorship.

Study Procedures for CRC and EC participants:

* You will be asked to donate 2-3 tablespoons of blood.
* A small piece of your colorectal or endometrial tumor will be obtained from the hospital where you had your surgery.
* You will be asked to contribute your leftover samples (tumor and blood) to the OCCPI biorepository (sample bank) for help with future research. Additionally, CRC participants will be asked to donate a saliva sample to the OCCPI biorepository. The samples will be kept securely in a lab at OSU. Before your samples can be used for research, the people doing the research must get specific approval from the OCCPI Steering Committee and possibly the Institutional Review Board (IRB) of OSU. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner.
* You will be asked to complete a questionnaire which will ask about your age, medical history, family history, lifestyle factors and environmental exposures. It should take about one hour to complete the questionnaire and you can complete it from home.
* We will test your tumor for features of LS (MSI, IHC, methylation).
* For CRC patients: if your tumor shows features of LS OR you were diagnosed under age 50 OR you have a family history of CRC or endometrial cancer OR you have synchronous or metachronous CRC or endometrial cancer, we will test your blood for the genes that cause LS, as well as other genes that can cause hereditary cancer.
* For endometrial cancer patients: if your tumor shows features of LS, we will test your blood for the genes that cause LS, as well as other genes that can cause hereditary cancer.
* Some patients may have tumor genetic testing.
* If you are found to have LS or another type of hereditary cancer, you will be offered free genetic counseling.
* If you are found to have LS, your at-risk relatives will be offered free genetic counseling and genetic testing.

Study Procedures for first-degree relatives (FDR) of the CRC participants:

The FDRs of all of the CRC study participants will be given the opportunity to contribute to the biorepository for future research.

* Family Member Consent for Contact forms will be provided to the CRC participant at the time of their enrollment for them to distribute to all of their FDRs (parents, siblings and adult children ≥ 25 years). The FDRs will mail the signed form to OSU.
* After obtaining permission to contact the FDRs, OSU will mail them the biorepository consent form and saliva kit to return to the OCCPI biorepository.
* The FDRs of the CRC study participants will also be invited to complete the baseline questionnaire.

Length of study:

* The LS tumor screening portion of the OCCPI will take 1-4 months.
* If applicable, genetic testing results should be ready in an additional 3-6 months.
* Overall, your participation in the LS screening portion of the OCCPI is expected to take about 1 year. Most of this time will be spent waiting for results. Your active involvement will take about 15 minutes on the day that you provide consent and about 60 minutes when you complete the questionnaire from home.

Ohio Colorectal Cancer Prevention Initiative

Ohio Colorectal Cancer Prevention Initiative: Universal Screening for Lynch Syndrome

Through tumor testing for Lynch syndrome and follow-up genetic testing for all patients with abnormal tumor testing and select patients with normal tumor testing (those diagnosed under age 50 and those at or over age 50 with a first degree relative with colorectal or endometrial cancer or synchronous or metachronous colon or endometrial cancer).

Ohio State University Comprehensive Cancer Center

Principal Investigator

Skin and Connective Tissue Diseases

Sarcoma

Sarcoma, Synovial

Neoplasms, Connective and Soft Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Synovial Sarcoma

Lauren Gutstein

James Robinson

Theodore Laetsch, MD

The purpose of this study is to collect and store data and samples for future research to attempt to improve outcomes for patients with synovial sarcoma. The future research will involve various types of genetic testing.

Participants will be asked to allow access to medical records and leftover tumor tissue and may be asked to give a blood or saliva sample. Participants will also be asked to completed questionnaires about their medical history and may be contacted every 6 to 12 months for updates for up to 10 years.

This study will enroll patients with a diagnosis of Synovial Sarcoma.

Following consent, demographic, clinical, treatment and outcome data will be collected from an interview and/or online survey. This will include a request for contact information for the subject's treating hospitals/physicians and a release of records request to obtain medical records.

At approximately 6-12 month intervals for up to 10 years after initial diagnosis and/or relapse, subjects and/or their treating hospitals may be contacted to provide updates on treatment and outcomes.

Tumor samples may be collected from residual material obtained during clinically indicated procedures occurring before or after consent to this study. No additional material will be collected or procedures performed solely for the purpose of this study.

Blood may be collected at the participant's local institution at the time of a clinically indicated blood draw and/or saliva or a buccal swab may be collected as a germline sample and for analysis of circulating free DNA (cfDNA) and/or circulating tumor cells (CTCs).

Genetic testing may be performed on tumor and germline samples submitted by subjects. Results will only be returned if deemed clinically significant.

Samples may include tumor tissue and its excipients (DNA, RNA, protein), blood, saliva, and/or buccal swabs.

Synovial Sarcoma Registry / Biospecimen Repository

Synovial Sarcoma Registry and Biospecimen Repository

De-identified data and specimens may be provided to other investigators for additional research use. Identifiable data will only be available to the study team.

Children's Hospital of Philadelphia

Eye Diseases

Infections

Neuromyelitis Optica

Neuritis

Optic Neuritis

Myelitis

Myelitis, Transverse

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Optic Nerve Diseases

Cranial Nerve Diseases

Demyelinating Diseases

Communicable Diseases

Central Nervous System Infections

Central Nervous System Diseases

Spinal Cord Diseases

Neuroinflammatory Diseases

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Neurodegenerative Diseases

Neuromyelitis Optica Spectrum Disorder

Transverse Myelitis

Patients diagnosed with NMOSD based on revised diagnostic criteria. Seronegative, anti-AQP4 seropositive and ant-MOG seropositive patients will be included

Patients who have had one demyelinating event, not diagnosed with multiple sclerosis and whom are considered at risk for NMO or NMOSD.

patients without a history of CNS inflammation

Jan Cameron-Watts, RN

Martha Mann, RN

Benjamin M Greenberg, MD, MHS

Benjamin M Greenberg, MD

This study seeks to determine the biologic causes of inflammation in patients with Transverse Myelitis (TM) Neuromyelitis Optica Spectrum Disorder (NMOSD) and related conditions. While patients will be treated according to decisions with their treating physician, this study will collect data and samples from patients prospectively to gain a better understanding of the disease. We are seeking to understand why some patients respond to medications, while others do not. We also seek to understand what happens biologically, preceding relapses. Gathering these data and samples will allow researchers to identify new ways of diagnosing and treating these diseases. Data and samples will be shared with researchers around the world to support collaborative efforts to treat these conditions.

This study seeks to determine the biologic causes of inflammation in patients with Neuromyelitis Optica (NMO), Transverse Myelitis (TM), optic neuritis (ON), related conditions and healthy controls. While patients will be treated according to decisions with their treating physician, this study will collect data and samples from patients prospectively to gain a better understanding of the disease. We are seeking to understand why some patients respond to medications, while others do not. We also seek to understand what happens biologically, preceding relapses. Gathering these data and samples will allow researchers to identify new ways of diagnosing and treating these diseases. Data and samples will be shared with researchers around the world to support collaborative efforts to treat these conditions.

Patients will agree to share medical records, complete questionnaires and donate samples on a timed basis.

Patients will donate serum, plasma, DNA, RNA and white blood cells.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Longitudinal Assessment of Marrow and Blood in Patients With Glioblastoma	NCT04657146	Glioblastoma	Biorepository	18 Years -	Duke University
Clinical Sequencing of Cancer and Tissue Repository: OncoGenomics	NCT03027401	Neoplasms Adenomatous Pol... Neurofibroma, P... Myelodysplastic...		- 99 Years	National Institutes of Health Clinical Center (CC)
Clinical Sequencing of Cancer and Tissue Repository: OncoGenomics	NCT03027401	Neoplasms Adenomatous Pol... Neurofibroma, P... Myelodysplastic...		- 99 Years	National Institutes of Health Clinical Center (CC)
Clinical Sequencing of Cancer and Tissue Repository: OncoGenomics	NCT03027401	Neoplasms Adenomatous Pol... Neurofibroma, P... Myelodysplastic...		- 99 Years	National Institutes of Health Clinical Center (CC)
Specimen Collection for Agricultural Health Study Cohort Pesticide Exposure Study	NCT01139476	Multiple Myelom... Leukemia MGUS Monoclonal B-Ce...		18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
The TIOB - Collection of Patients' Biospecimens for Analysis of Immunological and Molecular Biomarkers.	NCT05371756	Cancer		-	Baylor Research Institute
Longitudinal Assessment of Marrow and Blood in Patients With Glioblastoma	NCT04657146	Glioblastoma	Biorepository	18 Years -	Duke University
Longitudinal Assessment of Marrow and Blood in Patients With Glioblastoma	NCT04657146	Glioblastoma	Biorepository	18 Years -	Duke University
Biorepository for Precision Genomics	NCT02587026	Neoplasms	Blood sample co... Tumor tissue sa...	18 Years -	Indiana University
Ohio Colorectal Cancer Prevention Initiative	NCT01850654	Lynch Syndrome Colorectal Canc...	LS tumor screen... Genetic testing Genetic Counsel... Biorepository Questionnaire	18 Years -	Ohio State University Comprehensive Cancer Center
Synovial Sarcoma Registry / Biospecimen Repository	NCT05910307	Synovial Sarcom...		-	Children's Hospital of Philadelphia
The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders	NCT01623076	Neuromyelitis O... Neuromyelitis O... Transverse Myel... Optic Neuritis		6 Years -	University of Texas Southwestern Medical Center

Spots Global Cancer Trial Database for biorepository