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)

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

The swab is removed from packaging, moistened with sterile water if needed to prevent any discomfort to the participant. The swab is gently inserted less than one inch into the anterior nare (nostril) until resistance is met at turbinate. Then it is rotated several times against nasal wall and repeated in other nostril using the same swab.

Nasal Swab

The swab is removed from packaging, moistened with sterile water if needed to prevent any discomfort to the participant. The swab is gently rubbed along the inside of the participant's cheek for 5-10 seconds.

Oral Swab

A stool collection kit will be sent home with each participant. It will include instructions on how to collect the stool specimen and how to return the kit.

Stool Collection

Study of microbial communities found in and on the human body.

Microbiome analysis

Secure, long term storage of an individual's genetic material.

DNA Banking

Gentle rubbing of the swab will be applied to the skin on the dorsal part of the hand.

Skin Swab

Taher Abu Hejleh, MBBS

To characterize the fecal, skin, nasal and oral microbiome and metabolome in patients with lung cancer and other malignancies, and correlate to treatment response and toxicities of various therapies including immunotherapy, chemotherapy and targeted therapy, etc.

Patients will be asked to provide nasal, oral and skin swabs, as well as stool samples during their regular clinic visits, at the baseline before desired therapy is given, and at the time when treatment is changed due to either disease progression or unbearable toxicities leading to treatment stop/change. If treatment stop/held is due to toxicities, a 3rd set of samples will be collected when toxicities reduce to less than grade 1. The samples will be subjected to DNA extraction followed by 16S rRNA and/or shotgun sequencing metagenomic analysis. The data will be correlated to clinical response from treatments, toxicities, clinical data (use of antibiotics, PPIs, lab parameters, etc.) and tissue genetic/immunological characteristics (mutations, PDL1 expression, etc.) for review of response. This is not data to be used for treatment of these subjects.

Bacterial DNA will be isolated from oral, skin, and nasal swabs, as well as stool samples. The extracted DNA will be subsequently used for microbiome analysis.

Microbiome in Lung Cancer and Other Malignancies

The Role of Microbiome in Lung Cancer and Other Malignancies

Bacterial DNA will be isolated from stool/swab samples using standard protocol. Fecal micobiota will be examined based on an 16S rRNA amplicon.

Correlate data from samples with patient clinical information regarding overall response rates.

Record from each clinical visit the AEs from immunotherapy or its combination with chemotherapy.

Holden Comprehensive Cancer Center

Iowa Institute of Human Genetics

Taher Abu Hejleh

Clinical Associate Professor

Anticoagulants

All Drugs and Chemicals

Other Dietary Supplements

Citric Acid

Sodium Citrate

Citrate

additional biopsies will be performed during a diagnostic or therapeutic procedure, in order to sample tumor tissue and healthy tissue.

tissue biopsies

additional blood samples will be collected during a SOC sampling procedure (2 EDTA 7.5 ml tubes, 2 SST 7.5 ml tubes and 2 citrate 5 ml tubes)

blood sampling

constitutional and somatic genetic alterations will be analysed for subjects who consent, from either tumor or healthy tissue, or whole blood buffy coat after centrifugation

DNA banking

Alexis CORTOT, MD,PhD

Eric WASIELEWSKI, M

Alexis Cortot, MD,PhD

This prospective, single-center, interventional study is conducted in order to achieve a biological bank accompanied by clinical data. Blood samples, optional tumor tissue and fecal samples are collected, processed and banked for all the included subjects. Those samples are collected before the start of treatment, at the time of first tumor assessment, at the time of first and second disease progression. The subjects are treated according to standard of care.

Clinical data are collected at each sampling time. The primary objective of the study is to identify biological, clinical and tumoral factors associated with tumor response according SOC treatment.

serum, plasma, tumor tissue, healthy tissue, stools (gut microbiome)

A Clinico-biological Database of Lung Cancers

This mesure evaluate subject's emotional skills in regard of the clinical trial inclusion process between baseline and first disease assessment (T1), first occurence of progression (T2), second occurence of progression (T3)

This mesure evaluate between baseline and first disease assessment (T1), first occurence of progression (T2), second occurence of progression (T3)

Assessment of tumor response to SOC treatment, using RECIST 1.1 criteria (partial response defined as a decrease of at least 30% in size of target lesions, complete response defined as a disappearance of all lesions)

Assessment of tumor response to SOC treatment, using RECIST 1.1 criteria (disease progression defined as an increasement of at least 20 % in size of target lesions, and/or appearance of new lesions)

length (in days) and grade of the treatment-related toxicities, using Common Terminology Criteria for Adverse Events version 4

Institut Pasteur de Lille

University of Lille Nord de France

University Hospital, Lille

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)
Microbiome in Lung Cancer and Other Malignancies	NCT03688347	Lung Cancer Cancer Malignancy	Nasal Swab Oral Swab Stool Collectio... Microbiome anal... DNA Banking Skin Swab	18 Years - 100 Years	University of Iowa
A Clinico-biological Database of Lung Cancers	NCT03387865	Lung Cancer	tissue biopsies blood sampling DNA banking	-	University Hospital, Lille
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)

Spots Global Cancer Trial Database for dna banking

Every month we try and update this database with for dna banking cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dna banking

Every month we try and update this database with for dna banking 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 dna banking 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.