Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Neoplasms

Breast Diseases

Skin Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Biological relatives (1st-3rd degree) of participants with histologically confirmed malignancy

Participants with histologically confirmed malignancy

Jung-Min Lee, M.D.

Background:

A person s blood, tissue, and other samples contain DNA. Cancer is a disease of cells that are not working properly. It is caused by changes in DNA that build up. Researchers want to do future studies on DNA changes This may help them learn how to guide treatment for cancer. They need biological samples like tumors, blood, and urine for these studies.

Objective:

To create a place to collect and store biological samples from people with gynecologic malignancies like breast cancer. Samples from certain relatives of theirs will be collected too.

Eligibility:

Adults ages 18 and older who are being seen at NIH for breast cancer or other gynecologic malignancy

Their biological relatives of the same age

Design:

Participants will answer questions about their family history.

Participants will have a physical exam and medical history. This will include questions about age, ethnicity, and disease history. They will also answer questions about their medical treatments and responses.

Participants will give blood and urine samples.

Participants may give a tumor tissue sample. This will not be taken specifically for this study. It will be from a previous procedure or one that is already planned.

Other samples may be taken only if a procedure is required for treatment. These include bone marrow, cerebrospinal fluid, and other fluids.

A group of doctors and other professionals will oversee the sample storage place. The group will review all requests to be sure the use of the specimens is valid.

...

Background:

Increased understanding of the genomic variations of cancer through laboratory evaluations can result in breakthroughs in treatment and improved patient outcomes.

Exceptional responders on clinical trials may have mutational characteristics that are unique and unknown, necessitating identification.

Current drug development strategies employ precision oncology. This approach identifies molecular targets, with therapies being either chosen or developed to interact with the specific target.

The collection and banking of a variety of tissue samples for future translational studies would support research and advance the mission of the NIH.

Pleural effusions, ascites as well as other tissues, such as blood, CSF, tumor, bone marrow, and urine, provide a unique opportunity to conduct a variety of translational research, addressing many clinical questions.

The establishment of a tissue repository would enhance the mission of the NCI, in helping to advance research supporting precision oncology.

Primary Objective:

To establish a tissue repository for the collection and banking of tissue samples from patients with breast and/or other gynecologic malignancies, as well as patients consenting 1st -3rd degree biological relatives, seen at the NIH for support of future translational research conducted at the NIH.

Eligibility:

Personal diagnosis of breast or other gynecologic malignancy, or be a 1st-3rd degree biological relative of a patient with cancer, currently or previously on a NIH clinical trial.

All subjects (index patient with cancer and their 1st-3rd degree biological relatives) must sign consent and enroll onto this study, in order to donate tissue for biobanking on this protocol.

Adults, \>= age 18, willing to provide tissue for biobanking

Design:

Samples include, but are not limited to, tumor (e.g., tissue, outside paraffin blocks or slides), blood, serum, plasma, and urine; to be collected after subjects have met eligibility and signed consent. Clinically-indicated samples (e.g., bone marrow, cerebrospinal fluid (CSF), malignant ascites, and effusions) collected under treatment protocols may be transferred to this biorepository protocol for research We will also obtain samples (mainly blood) from volunteer, consenting 1st-3rd degree biological relatives of patients with histologically confirmed cancer, to be paired with their family member.

Tissue will be accessed by study investigators. Additional CCR investigators who wish to use tissue from this repository must first provide a written Letter of Intent, (LOI), to be reviewed by an investigator appointed ad hoc committee for approval.

Assays used for sample processing, establishment of cell lines, patient derived xenograft models, and storage are described in detail within this protocol. Also, some assays for future translational research are either listed or described herein. Further detailed description of experimental designs, along with statistical analysis, will be provided within future investigator-initiated sample use addendums to this protocol, or new IRB approved protocols, developed in order to study samples from this biorepository.

Tissue Acquisition and Genomics Analysis of Breast Cancer and Other Gynecologic Malignancies

.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

National Cancer Institute (NCI)

Patients with cancer or who are at risk of having cancer who have given consent to have blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) collected and stored for the advancement of medicine.

Collection of blood, tissue, and other biological samples.

Biospeciman Collection

Data taken from patient surveys and assessments, including quality of life.

Survey Assessments

Data taken directly from the patients' medical charts.

Medical Chart Reviews

Virginia Borges, MD

Kyra Anderson

Virgina Borges, MD

Alicia Deschaine

Robert Hoyer, MD

Nathan Ketelhut

Steven Schuster, MD

This is not a treatment study. The overall objective is to develop an improved standard of care through studying blood, tissue, biological, etc. samples, that patients have allowed researchers to procure.

The Oncology Research Information Exchange Network (ORIEN) hopes to establish a unique collection of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) from thousands of patients with cancer or at risk of having cancer. Their hope is to, over time, facilitate new clinical trials, technology, informatics solutions, and personalized medicine to each cancer patient.

A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer

Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer (ORIEN)

Establish a longitudinal clinical and related data and tissue repository that will contain patient demographics via surveys and questionnaires.

Establish a longitudinal clinical and related data and tissue repository that will contain medical histories via surveys and questionnaires.

Establish a longitudinal clinical and related data and tissue repository that will contain cancer predisposing risk factors via surveys and questionnaires.

Establish a longitudinal clinical and related data and tissue repository that will contain quality of life care via surveys and questionnaires

Establish a longitudinal clinical and related data and tissue repository that will contain blood samples from consenting patients.

Establish a longitudinal clinical and related data and tissue repository that will contain tissue samples from consenting patients

Establish a longitudinal clinical and related data and tissue repository that will contain other biological samples from consenting patients

University of Colorado, Denver

Eye Diseases

Diseases and Abnormalities at or Before Birth

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

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

Nervous System Diseases

Symptoms and General Pathology

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Neurofibroma, Plexiform

Nerve Sheath Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Neurofibromatosis

Neurofibromatosis Type 1

Brigitte C Widemann, M.D.

Background:

-Plexiform neurofibromas in patients with NF1 are a significant cause of morbidity but little is known about the natural history of these lesions.

Objectives:

* The purpose of this study is to monitor the natural history of plexiform neurofibromas and to evaluate the usefulness of volumetric MRI tumor measurements in this disease.
* Other goals of the study are to provide a body of normative data on the growth rate of plexiform neurofibromas and to establish a tissue repository and pathology review center to allow future studies of the pathogenesis of neurofibromas and clinical trials of potential therapeutic agents.

Design

- This study is coordinated by Dr. Bruce Korf, and was initiated when he was at the Partners Center for Human Genetics, Boston, MA.

Study of Plexiform Neurofibromas in Neurofibromatosis Type 1

Natural History of Plexiform in Neurofibromatosis Type I

Monitor natural history of plexiform neurofibromas

Usefulness of volumetric MRI measurements

Melanie Royce, MD

The Expanded Breast Cancer Registry and Tissue Repository Research Team (EBCR-RT) is comprised of University of Mexico Comprehensive Cancer Center faculty and staff whose goals are to improve the outcomes and quality of life of patients with breast cancer, and ultimately to eradicate and cure breast cancer. One focus of the EBCR-RT is the creation an infrastructure that can potentially be adopted as a model for a statewide registry and tissue repository for the discovery of biomarkers for this disease.

The goals of the EBCR are:

1. To register patients diagnosed with breast cancer and information relevant to their diagnosis (such as stage, grade, hormone receptor status, etc), treatment (surgery, radiation, chemotherapy, hormone therapy, etc), and survivorship (Quallity of Life, etc).
2. To collect relevant demographics including age, menopausal status, race/ethnicity, body mass index (BMI), place of residence, behaviors (smoking, alcohol intake, etc)
3. To establish a paired tumor tissue and blood sample for each relevant time-point (as defined in the protocol), which will be stored in the Tissue Bank Shared Resource Facility for future hypothesis-driven research.

Institutions and/or physicians are required to report each new diagnosis of breast cancer to the New Mexico Tumor Registry (NMTR). The NMTR is a valuable database that provides information on breast cancer, including trends in incidence and survival. However, relevant information on breast cancer prognosis and treatment is either not routinely collected or not readily available to the NMTR. We propose to establish an Expanded Breast Cancer Registry and Tissue Repository (EBCR) at this institution that could serve as an infrastructure for collection of this information. Furthermore, a tissue bank will be established for collection of paired tissue (tumor, buccal cells and blood sample) from patients diagnosed with breast cancer who consent to providing excess/extra tissue and additional blood for the Tissue Repository. This tissue bank will serve as a repository from which researchers can access tissue samples to conduct laboratory-based studies of genetic determinants of breast cancer risks, prognosis and survival in women with breast cancer seen in this institution.

Sample of tumor, buccal cells and blood collected at the time of study enrollment.

Expanded Breast Cancer Registry and Tissue Repository

Utilize the Extended Breast Cancer Repository clinical database to determine the relationship between clinico-pathologic variables and patient outcomes.

Prospectively collect demographic, risk factor, diagnosis and treatment data and tissues (blood, buccal cells and tumor if appicable) for breast cancer patients seen at the UNM Cancer Center to assist in identification of unique factors that may impact patient prognosis in this population.

Establish a centralized tissue repository (breast and related tissues) to serve as a resource for current and future scientific studies.

University of New Mexico

New Mexico Cancer Care Alliance

Uterine Cervical Neoplasms

Uterine Cervical Diseases

All Drugs and Chemicals

Mitogens

Tissue Repository

Claire Verschraegen, MD

The Tissue Repository will search for cases, pull slides, Paraffin-embedded tissue (PET) blocks.

This study is done to gather preliminary data for determining the best way to test EGFR expression in patients with cervical cancer who will receive treatment with EGFR inhibitors in the future.

This study is designed to obtain preliminary data of genomic and phenotypic alterations of the EGFR pathway in high grade cervical intraepithelial lesions (HG-SIL) and invasive cervical cancers (CC) to be used later for therapeutic guidance and to evaluate genomic (over-expression, amplification, point mutations, etc.) and phenotypic alterations of other transduction pathways interacting with the EGFR pathway.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tissue Acquisition and Genomics Analysis of Breast Cancer and Other Gynecologic Malignancies	NCT03762733	Breast Cancer Ovarian Cancer Uterine Cancer		18 Years -	National Institutes of Health Clinical Center (CC)
A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer	NCT03617939	Cancer Risk	Biospeciman Col... Survey Assessme... Medical Chart R...	18 Years -	University of Colorado, Denver
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)
A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer	NCT03617939	Cancer Risk	Biospeciman Col... Survey Assessme... Medical Chart R...	18 Years -	University of Colorado, Denver
A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer	NCT03617939	Cancer Risk	Biospeciman Col... Survey Assessme... Medical Chart R...	18 Years -	University of Colorado, Denver
Study of Plexiform Neurofibromas in Neurofibromatosis Type 1	NCT00006435	Plexiform Neuro... NF1		- 100 Years	National Institutes of Health Clinical Center (CC)
Tissue Acquisition and Genomics Analysis of Breast Cancer and Other Gynecologic Malignancies	NCT03762733	Breast Cancer Ovarian Cancer Uterine Cancer		18 Years -	National Institutes of Health Clinical Center (CC)
Expanded Breast Cancer Registry and Tissue Repository	NCT00322894	Breast Cancer		18 Years -	New Mexico Cancer Care Alliance
Assessment of EGFR Genomic Alterations as Prognostic Markers in Cervical Cancer	NCT00298064	Cervical Cancer Cervix	Tissue Reposito...	-	University of New Mexico

Spots Global Cancer Trial Database for tissue repository