Neoplasms

All Conditions

Ear, Nose, and Throat Diseases

Nervous System Diseases

Symptoms and General Pathology

Mouth and Tooth Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Head and Neck Neoplasms

Hearing Disorders

Pharyngeal Neoplasms

Laryngeal Diseases

Ear Diseases

Otorhinolaryngologic Diseases

Sensation Disorders

Neurologic Manifestations

Respiratory Tract Diseases

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Subjects must be diagnosed with a disorder of the head and neck region

Melissa Missy L Wheatley

Clint T Allen, M.D.

Michael Hoa, M.D.

Nyall London, M.D.

Richard Lush, Ph.D.

National Cancer Institute Referral Office

Background:

Researchers want to learn more about head and neck disorders. Understanding these disorders could help them find better treatments. To do this, they are collecting tissue samples for research.

Objective:

To create a repository of tissue samples and data to better study conditions of the head and neck.

Eligibility:

People who had or will have tissue samples taken because of a head or neck disorder. They must be ages 3 and older and not pregnant to join Part 2.

Design:

Participants will be screened with a questionnaire, medical history, and physical exam.

Part 1. Participants will give permission for any of their tissue samples leftover from private care or other research protocols to be used.

If participants tissue did not contain normal tissue or if they have a condition that suggests a genetic issue, they will be invited to join Part 2.

Part 2: Participants will have additional samples collected. These could be:

* Blood: Blood is drawn through a needle in the arm.
* Cheek swab or brushing: A cotton swab or small brush is rubbed inside the cheek.
* Saliva: They rinse their mouth with water and spit into a tube or cup.
* Skin biopsy: They are injected with a numbing drug. A biopsy tool removes a small piece of skin.
* Mucosal biopsy: They are injected in the mouth with a numbing medication. A small piece of tissue from the inside of the cheek is removed.

Participants samples will be used for future research, including genetic testing.

...

Background:

NCI Head and Neck Clinical Research Program (H\&N CRP) investigators are studying the natural history and treatment of diverse conditions of the head and neck at the National Institutes of Health (NIH). These studies require the collection of biospecimens for research purposes.

Studies performed may support development of future protocols that include new therapeutic agents, novel treatment approaches, and new prognostic and diagnostic models for individuals with disorders of the head and neck affecting human communication.

Objectives:

* Primary: To create a biorepository of diseased and normal tissue specimens for research purposes from individuals with head and neck disorders.
* Secondary: To share specimens for Patient-Derived Xenograft (PDX) and organoid research, as well as analysis of cellular, molecular, genetic and genomic biology of normal processes and disorders.

Eligibility:

* Participants must be diagnosed with a disorder of the head and neck region.
* Age \>= 3 years

Design:

* Up to 1000 participants will be enrolled.

  * Part 1: Participants with head and neck disorders will be asked to share waste material from surgical procedures to create a biorepository of diseased and normal specimens for research. The participants will be enrolled prior to the surgery, or they may be enrolled retrospectively and asked to share pathology specimens and slides previously collected that are no longer required for their medical care. Participants will be recruited from surgical protocols at the National Institutes of Health (NIH) Clinical Center or from other participating sites.
  * Part 2: Participants who have agreed to share surgical waste material may be asked to provide additional blood, saliva, and/or oral swabs. In addition, oral mucosal or skin biopsies may be obtained from adult participants aged 18 and older.
* No investigational or experimental therapy will be given as part of this protocol.

Biospecimen Procurement for Head and Neck Disorders

Biospecimen Procurement for the Study of Head and Neck Disorders

The primary endpoint of this study is the creation of a head and neck biorepository from both surgical waste material and prospectively collected blood, saliva, oral swabs, oral mucosa biopsy and skin biopsy specimens.

National Cancer Institute (NCI)

Digestive System Diseases

Rare Diseases

Carcinoma

Stomach Neoplasms

Carcinoma, Hepatocellular

Cholangiocarcinoma

Biliary Tract Neoplasms

Gallbladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Adenocarcinoma

Liver Neoplasms

Liver Diseases

Biliary Tract Diseases

Gallbladder Diseases

Stomach Cancer

Bile Duct Cancer

Biliary Tract Cancer

Gallbladder Cancer

Gang Chen, M.D.

Hepatobiliary tumors have a poor prognosis and high individual heterogeneity, the patient with hepatobiliary tumors even accepted radical surgery, the postoperative recurrence rate is still high. Therefore, it is of great significance to find important prognostic markers to improve patient prognosis and formulate new treatment plans. In recent years, targeted therapy and immunotherapy make cancer treatment enter a new field, However, tumor heterogeneity is the greatest challenge in cancer therapeutics and biomarkers discovery. In this study, we collected a wide rang of patients' information, including photos of patients' face, physical strength and nutrition indicators, blood ,stool and pathological tissue specimens from tumor patients, then Multi-omics testing were applied to Looking for novel therapeutic targets and prognostic markers to predict patient response to treatment. Clinicians choose the best treatment plan for the patient based on the test results to improve the patient's survival time and quality of life.

This is an ongoing, longitudinal, observational clinical cohort study of patients with tumors of the alimentary tract, mainly hepatobiliary tumors. All the patients are diagnosed, treated and followed up. In the future, some other patient information will be gradually updated to this database

normal tissue, tumor samples, blood, urine, feces, ascites, bile samples

Observational Study on Patients With Hepatobiliary Tumors

In order to identify the potential influence factors of hepatobiliary tumor patients survival

In order to identify the potential influence factors of tumor recurrencesamples from patients with hepatobiliary cancers

In order to identify the potential influence factors of tumor-induced death in patients with hepatobiliary tumors

In order to identify the potential influence factors of tumor progression from patients with hepatobiliary cancers

Gang Chen, MD

Division Chief of Education; Deputy Director of Hepatobiliary Surgery

Skin and Connective Tissue Diseases

Breast Neoplasms

David N Danforth, M.D.

Background:

* Many risk factors for breast cancer have been identified, including family history, endocrine background, changes in breast tissue, cancer in one breast, radiation exposure, obesity and others. There is a spectrum of tissue changes seen in cancerous and pre-cancerous breast tissue.
* A cell line is a collection of cells that are grown in the laboratory from an original tissue specimen. Cell lines developed from high-risk breast tissue allow researchers to perform metabolic and molecular studies of breast cells over time.

Objective: To establish a repository (facility in which tissue samples can be preserved and stored for many years) of cell lines from high-risk breast tissue to allow researchers to learn more about changes in breast cells that may cause them to develop into breast cancer.

Eligibility: Women between 20 and 80 years of age who:

* Have an increased risk of breast cancer because they are members of a high-risk breast or ovarian cancer family.
* Have had breast cancer in one or both breasts.
* Have had radiation for lymphoma before the age of 30.
* Have a mutation in a breast cancer susceptibility gene, but whose family history is not known.
* Are not at increased risk of breast cancer.

Design:

* A small piece of breast tissue will be obtained from about 10 women without an identified risk of breast cancer and up to 100 women at high risk of developing breast cancer.
* Cell lines will be developed from each high-risk category.
* The cell lines and tissues will be used to establish a repository of high-risk breast cell lines and breast tissues that can be used to study how the cells develop into breast cancer.

Background:

The NCI Surgery Branch

Multiple risk factors for breast cancer have been identified, including family history, endocrine background, histologic changes in breast tissue, cancer in one breast, radiation exposure, obesity, and others. The histologic phenotypes of breast carcinogenesis include a spectrum of changes, beginning with normal appearing breast epithelium, progressing to hyperplasia, atypical hyperplasia, in situ carcinoma, and finally invasive carcinoma.

Our present knowledge of high risk breast tissue is based on the study of a variety of cellular sample types, which include fine needle aspirates, nipple aspirate fluid, core needle biopsies, and breast tissue from mastectomy or segmentectomy specimens.

Valid preclinical models are needed which utilize homogenous human cellular material which can be studied over time in large quantities.

A model which may be ideally suited to the metabolic and molecular studies of breast epithelial cells is an in vitro cell line model developed from high risk breast tissue.

In this study normal breast tissue will be acquired from each of the high risk sites for breast cancer in the breast. These tissues will be used to develop breast epithelial cell lines for in vitro studies, and to establish a high risk cell line and tissue repository.

Objectives:

To acquire normal breast tissue from each of the high risk sites for breast cancer in the breast.

To develop breast epithelial cell lines from the normal high risk breast tissue from each of the major high risk sites.

To establish a repository of high risk breast epithelial cell lines and high risk normal breast tissue which can be used as a resource for pilot studies at NIH and other participating centers to characterize high risk breast epithelial cells

Eligibility:

Women age 20 - 80 years who have an increased risk of breast cancer because they are members of a high risk breast or ovarian cancer family.

Women with a history of ipselateral breast cancer, either invasive or in situ, and a normal contralateral breast by mammography (within the past 12 months) and a normal physical examination of the contralateral breast and adjacent lymph node bearing areas, or be undergoing prophylactic mastectomy.

Women without breast cancer but with a Gail model estimate of 5-year risk of breast cancer of 1.67 percent or higher.

Women with bilateral breast cancer (invasive or in situ) who have not received whole breast irradiation to both breasts.

Women with a previous history of mediastinal irradiation for lymphoma before the age of 30 and who are now greater than 5 years since completing radiation therapy.

Normal women not at increased risk of breast cancer (Gail model Index of less than 1.50 percent) and without abnormal findings in the breast by physical examination and mammography to serve as normal control tissue.

Women with a mutation in a breast cancer susceptibility gene, but whose family history is not known.

Absence of significant cardiac, hepatic or renal disease, which, in the opinion of the PI, is likely to cause metabolic changes in the breast tissue.

Design:

A tissue acquisition in which Normal breast tissue will be collected from women at high risk of breast cancer at NIH and at other institutions as well. Centers collecting tissue for this protocol must have IRB approval for this study and an IRB approved Informed Consent.

All breast tissue will be obtained from surgical specimens acquired as part of planned surgical procedures. Short-term cell lines will be developed from this tissue and confirmed cytologically and by expression of cytokeratins. Multiple cell lines from each of the high risk categories will be developed.

These cell lines and the respective tissues will be used to establish a repository of high risk breast epithelial cell lines and high risk breast tissues which can be used to further define the carinogenic pathway for breast cancer. Early passages of these cell cultures and the respective normal breast tissue will be stored for future studies.

100 patients will be enrolled over a period of 5 years.

Cell Lines From High-Risk Breast Tissue

Establishment of Normal High Risk Breast Epithelial Cell Cultures, and A High Risk Cell Line and Tissue Repository From Breast Tissue From Women at High Risk of Breast Cancer

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

All Drugs and Chemicals

Amino Acids

Mitogens

Tyrosine Kinase Inhibitors

Tyrosine

The gene testing of re-biopsy tissue sample diagnosed with NSCLC will be performed with NGS using Illumina Miseq squencer and Cobas.

The peripheral blood sample will be extracted with DNA and performed with NGS using Illumina Miseq squencer and ddPCR.

The sequencer will be used to detect the gene mutations of the re-biopsy tissue samples and peripheral blood samples obtained from patients.

Miseq sequencer

Jiayuan Sun, MD, PhD

The objective of the study is to reveal the acquired resistance mechanism of the first and second generation Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) in tissue and plasma using Next Generation Sequencing (NGS) and the difference of ctDNA in plasma and DNA in biopsy samples is compared and the consistency of two samples was observed. At the same time, the sensitivity, specificity and the consistency of detecting T790M mutation using ddPCR, Cobas and NGS were compared.

With the deepening of the concept of tumor management, it is necessary to monitor the patient's gene during the course of treatment, especially in patients with acquired resistance of the first generation EGFR-TKI. Re-biopsy can effectively provide tissue samples as a "gold standard" for gene detection samples. While, the plasma circulating tumor DNA (ctDNA) detection is an important sample of gene detection and the treatment when tissue samples cannot be assessed. However, due to tumor heterogeneity and ctDNA detection technique sensitivity, plasma ctDNA and tissue samples of the test results are inconsistent. Therefore, the difference between re-biopsy tissue samples and plasma ctDNA samples will provide strong evidence for the application of plasma ctDNA in TKI-resistant patients.

The study was designed as a prospective and single center study. Fifty patients will be enrolled into the study and the clinical data of patients, including smoke history, cancer history, location, pathology, gene mutation status and so on of the first biopsy samples will be collected and recorded in a case report form. For patients recruited in the study, lesions which were assessed as progressive disease(PD) will be obtained by interventional pulmonology technology. And about 20ml peripheral blood will be collected at the same time. The tissue will be divided into two parts, one part was sent to Pathology Department of Shanghai Chest Hospital and will be processed with paraffin-embedded, and for those diagnosed NSCLC, the other part will be extracted with DNA and performed NGS for the qualified DNA sample and using Cobas to detect the T790M mutation. The matched peripheral blood will also be extracted with DNA and performed NGS and ddPCR.

Analysis of Re-biopsy Specimens in Advanced NSCLC With Acquired Resistance of EGFR-TKI Targeted Therapy

Analysis of Re-biopsy Specimens in Advanced Non-small Cell Lung Cancer With Acquired Resistance of Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor Targeted Therapy

differences of gene mutation between re-biopsy tissue sample and peripheral blood sample will be tested by NGS

Shanghai Chest Hospital

Director, Endoscope Department, Shanghai Chest Hospital

Hearing Loss

Deafness

Patients with head and neck conditions affecting hearing, balance, smell, taste, swallowing, voice and speech.

Marcia L Mulquin, R.N.

Joshua Levy, M.D.

Marcia Mulquin, RN, MSN

NIH Clinical Center Office of Patient Recruitment (OPR)

Background:

Many disorders of the head and neck can affect a person s hearing; balance; smell; taste; swallowing; voice; or speech. These disorders include cancers and genetic and inflammatory diseases. To find better ways to diagnose and treat these disorders, researchers need to study tissues and other biological samples from people who have them.

Objective:

To collect biological samples for a repository that will be used for research.

Eligibility:

People of any age with a disorder of the head and neck that requires the taking of biological samples. The conditions may be any that affect hearing; balance; smell; taste; swallowing; voice; or speech.

Design:

Part 1: Participants will give permission for their leftover tissue samples to be used for research. These are tissue samples from the head and neck that were collected in the course of routine tests and care or other research studies. Information on each participant s age, diagnosis, and previous treatments will also be collected.

Part 2: Some participants may be asked for more samples. All those aged 3 years or older will have a physical exam. They will provide blood and saliva samples. A cotton swab or brush will be used to collect cells from the inside of the cheek.

Participants 18 years or older may have additional tests. They may provide nasal secretions: A piece of gelfoam or a sponge will be placed in the nose to soak up secretions for 5 to 10 minutes. They may have biopsies: Small samples of tissue will be cut from the skin and the tissue lining the mouth.

Samples may be used for genetic testing.

Study Description:

National Institute on Deafness and Other Communication Disorders (NIDCD) investigators are studying the natural history and treatment of diverse conditions of the head and neck affecting hearing, balance, smell, taste, swallowing, voice and speech at the National Institutes of Health (NIH). These studies require the collection of biospecimens for research purposes.

Objectives:

Primary:

To create a biorepository of diseased and normal tissue specimens for research purposes. The samples will be obtained:

(Part 1) From surgical waste materials from participants of all ages in NIH protocols who have head and neck disorders.

(Part 2) Participants aged 3 and older may have collection of blood, saliva, and/or oral swabs. Participants aged 18 and older, may undergo oral mucosal biopsies and skin biopsies and nasal secretion collection, taken from subjects with head and neck disorders.

Secondary:

The specimens may be shared with the NCI Frederick Patient-Derived Xenograft (PDX) team, other approved protocols or may be used under this protocol to conduct analysis of cellular, molecular, genetic and genomic biology of normal processes and disorders. These laboratory studies may support development of future protocols that include new therapeutic agents, novel treatment approaches, and new prognostic and diagnostic models for subjects with disorders of the head and neck affecting human communication.

Endpoints:

The primary endpoint of this study is the creation of a head and neck biorepository from both surgical waste material and prospectively collected blood, saliva, oral swabs, oral mucosa biopsy and skin biopsy specimens.

NIDCD Otolaryngology Clinical Protocol Biospecimen Bank

(Part 1) From surgical waste materials from participants of all ages in NIH protocols who have head and neck disorders.(Part 2) Participants aged 3 and older may have collection of blood, saliva, and/or oral swabs. Participants aged 18 and older, may undergo oral mucosal biopsies and skin biopsies and nasal secretion collection, taken from subjects with head and neck disorders.

These laboratory studies may support development of future protocols that include new therapeutic agents, novel treatment approaches, and new prognostic and diagnostic models for subjects with disorders of the head and neck affecting human communication

National Institute on Deafness and Other Communication Disorders (NIDCD)

Musculoskeletal Diseases

Osteosarcoma

Bone Neoplasms

Bone Diseases

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Soft Tissue Sarcoma

Patients that require the retrieval of a bone allograft (transplant).

A leftover sample of the removed allograft bone will be collected.

Tissue Sample

Valerae O. Lewis, MD

Primary Objectives:

1. To evaluate the material properties, histomorphometric indices, bone mineral density (BMD), and presence of microfractures in retrieved large allograft cortical bone specimens removed from orthopaedic oncology patients.
2. To correlate physical properties to patient demographics and medical treatment received.

Allograft Surgery:

As a standard of care, you will be having surgery to remove allograft tissue that has failed or because there were other complications following your earlier transplant. You will be separately consented for this surgery, which will describe the procedure and its risks in detail.

Tissue Research:

If you agree to take part in this study, leftover sample of the removed allograft bone will be collected and used to learn about the properties (such as bone strength, bone density, and new bone formation) of the removed transplant tissue. This tissue will be stored at the University of Arkansas for use in this study. Any remaining leftover tissue will be destroyed by the end of December 2011.

Data Collection:

Before you have surgery, you will have an x-ray. This is also part of standard of care. If you take part in this study, this x-ray will be used to learn about the properties of the transplant tissue.

All other information will be coming from your medical record, either from your past visits or as a result of your surgery. The information being collected will include information about your graft during the time it was within your body and observations made by your surgeon at its removal.

Length of Study:

Your participation in this study will be over after your tissue and data are collected.

This is an investigational study. Up to 200 patients will be enrolled on this multicenter study. Up to 20 will be enrolled at M. D. Anderson.

A leftover sample of the removed allograft bone will be collected and used to learn about the properties (such as bone strength, bone density, and new bone formation) of the removed transplant tissue.

Retrospective Study of the Biomechanical Properties of Large Allografts

Retrieved Allograft Study: Retrospective Study of the Biomechanical Properties of Large Allografts

Musculoskeletal Transplant Foundation

M.D. Anderson Cancer Center

Background:

Researchers want to learn more about head and neck disorders. Understanding these disorders could help them find better treatments. To do this, they are collecting tissue samples for research.

Objective:

To create a repository of tissue samples and data to better study conditions of the head and neck.

Eligibility:

People who had or will have tissue samples taken because of a head or neck disorder. They must be ages 3 and older and not pregnant to join Part 2.

Design:

Participants will be screened with a questionnaire, medical history, and physical exam.

Part 1. Participants will give permission for any of their tissue samples leftover from private care or other research protocols to be used.

If participants tissue did not contain normal tissue or if they have a condition that suggests a genetic issue, they will be invited to join Part 2.

Part 2: Participants will have additional samples collected. These could be:

* Blood: Blood is drawn through a needle in the arm.
* Cheek swab or brushing: A cotton swab or small brush is rubbed inside the cheek.
* Saliva: They rinse their mouth with water and spit into a tube or cup.
* Skin biopsy: They are injected with a numbing drug. A biopsy tool removes a small piece of skin.
* Mucosal biopsy: They are injected in the mouth with a numbing medication. A small piece of tissue from the inside of the cheek is removed.

Participants samples will be used for future research, including genetic testing.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Biospecimen Procurement for Head and Neck Disorders	NCT03429036	Hearing Disorde... Oral Mucosal Di... Pharyngeal Neop... Head and Neck N... Laryngeal Disea...		3 Years - 120 Years	National Institutes of Health Clinical Center (CC)
Observational Study on Patients With Hepatobiliary Tumors	NCT04637048	Hepatocellular ... Cholangiocarcin... Gallbladder Can... Biliary Tract C... Gastric Cancer Colorectal Canc...		18 Years -	First Affiliated Hospital of Wenzhou Medical University
Cell Lines From High-Risk Breast Tissue	NCT00032201	Healthy		20 Years - 80 Years	National Institutes of Health Clinical Center (CC)
Analysis of Re-biopsy Specimens in Advanced NSCLC With Acquired Resistance of EGFR-TKI Targeted Therapy	NCT03309462	Lung Cancer	Miseq sequencer	18 Years - 80 Years	Shanghai Chest Hospital
NIDCD Otolaryngology Clinical Protocol Biospecimen Bank	NCT06303180	Hearing Loss Head and Neck N... Hearing Disorde... Laryngeal Disea...		3 Years - 99 Years	National Institutes of Health Clinical Center (CC)
NIDCD Otolaryngology Clinical Protocol Biospecimen Bank	NCT06303180	Hearing Loss Head and Neck N... Hearing Disorde... Laryngeal Disea...		3 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Retrospective Study of the Biomechanical Properties of Large Allografts	NCT00632294	Bone Cancer	Tissue Sample	-	M.D. Anderson Cancer Center
Cell Lines From High-Risk Breast Tissue	NCT00032201	Healthy		20 Years - 80 Years	National Institutes of Health Clinical Center (CC)
Biospecimen Procurement for Head and Neck Disorders	NCT03429036	Hearing Disorde... Oral Mucosal Di... Pharyngeal Neop... Head and Neck N... Laryngeal Disea...		3 Years - 120 Years	National Institutes of Health Clinical Center (CC)
Cell Lines From High-Risk Breast Tissue	NCT00032201	Healthy		20 Years - 80 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for tissue sample