Digestive System Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Gastroesophageal Reflux

Laryngeal Diseases

Laryngopharyngeal Reflux

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Deglutition Disorders

Esophageal Diseases

Gastrointestinal Diseases

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

Brush biopsy of the larynx - in addition to the standard biopsy

Brush biopsy of the larynx at the post cricoid region - in addition to the standard examination for LPR (PH monitoring double probe)

In patients with laryngeal lesion the brush biopsy will be taken with the standard cup biopsy - either in the clinic or in the OR. In LPR patients brush biopsy will be taken in the clinic.

Endo CDx Brush biopsy

Jacob Cohen, MD

The study will take place at Rambam medical center, department of Otolaryngology Head and Neck Surgery, for two years. Patients suspected of LPR or laryngeal l tumor and are candidate for laryngeal or hypopharyngeal biopsies will be recruited.

First- all patients visiting our clinic with laryngeal complaints suspicious for either LPR or laryngeal tumor will fill the RSI questionnaire. Then fiberoptic examination will be performed by a laryngologist that will complete the RFS score.

Patients with suspicious lesions will be referred for TFL standard biopsy and CDx brush biopsy in order to determine whether the lesions are malignant or benign. The pathologic diagnosis of invasive carcinoma from a TFL biopsy is considered equivalent to the pathology results from a direct laryngoscopy biopsy. All patients with benign pathology or carcinoma in-situ (CIS) on TFL biopsy will be referred for subsequent direct laryngoscopy (DL) for definitive diagnosis. At the time of the DL biopsy will include also another CDx brush smear. Patients with benign-appearing lesions will be taken for lesion removal and biopsy.Before removal of the lesion a CDx brush smear will be collected.

All the participants suspected of LPR will have: PHmetry with Manometry andCDx brush biopsy.All relevant demographic and clinical data will be retrieved for analysis.

CDx biopsies will be an addition to the routine management of the patients in the diagnosis and follow-up of laryngeal lesions and LPR and will not replace the standard regimen.

CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions

Efficacy of EndoCDx brush biopsy as a diagnostic tool for laryngeal lesions compared to cup forceps biopsy and a diagnostic tool for LPR compared to double probe PH monitoring

Assessment of pain during EndoCDx brush biopsy under local anesthesia by Visual Analog Score for pain

Rambam Health Care Campus

CDx Diagnostics

Neoplasms

Nervous System Diseases

Symptoms and General Pathology

Mouth and Tooth Diseases

Head and Neck Neoplasms

Hearing Disorders

Pharyngeal Neoplasms

Ear Diseases

Sensation Disorders

Neurologic Manifestations

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)

Behaviors and Mental Disorders

Rare Diseases

Paralysis

Vocal Cord Paralysis

Dysphonia

Hoarseness

Globus Sensation

Voice Disorders

Vagus Nerve Diseases

Cranial Nerve Diseases

Conversion Disorder

Hysteria

Dissociative Disorders

Somatoform Disorders

Mental Disorders

Psychotic Disorders

Spasmodic Dysphonia

Participants will attend a single 15-30 minute study session during which they will answer questionnaires (5-10 minutes) and undergo laryngopharyngeal sensory testing (10-20 minutes). There will be up to 2 years of medical record follow up after completing the main study.

The Cheung-Bearelly Aesthesiometer will be used to deliver a range of calibrated stimuli through the channeled flexible laryngoscope to assess sensation of the laryngopharynx.

Cheung-Bearelly Aesthesiometer

A procedure to examine your larynx (voice box)

Transnasal Laryngoscopy

Patient-reported health and behavioral outcomes measures will be administered

Questionnaires

James Lappin, Jr.

Yue Ma, MD

A previous study completed in 2022 (NCT05158179) was conducted using cohorts of healthy controls, and adults with general laryngopharyngeal disorders. This study will expand on the previous research to include a separate cohort of adults being seen in clinic for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments.

PRIMARY OBJECTIVES:

I. Laryngeal sensation as measured by elicitation of laryngeal adductor reflex (LAR).

II. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to the Penetration-Aspiration Scale (PAS).

SECONDARY OBJECTIVES:

I. To assess patient-reported laryngeal sensation (PRLS) following stimulus and perceptual strength.

II. To assess laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus.

III. To assess patient reported outcomes (PROs).

EXPLORATORY OBJECTIVES:

I. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to:

* modified barium swallow (MBS) study kinematics;
* MBS Dynamic Imaging Grade of Swallowing Toxicity (MBS DIGEST);
* MD Anderson Dysphagia Inventory patient reported outcomes measure (MDADI PROMs);
* Dynamic Imaging Grade of Swallowing Toxicity for Flexible Endoscopic Evaluation of Swallowing (DIGEST-FEES)
* Flexible Endoscopic Evaluation of Swallowing Visual Analysis of Swallowing Efficiency and Safety (FEES VASES).

OUTLINE:

Participants receiving care at University of California, San Francisco (UCSF) for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments will undergo laryngopharyngeal sensory testing at a single visit. There will be up to 2 years of medical record follow up after completing the main study. Data collected from this separate cohort may be compared with historical data collected in a previous study (NCT05158179).

Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort

Assessment of Laryngopharyngeal Sensation in Patients With Laryngopharyngeal Disorders

Elicitation of LAR is defined as a unilateral or bilateral laryngeal adduction immediately following laryngeal stimulus through frame-by-frame analysis of video recordings (visualized on laryngoscopy). An acceptable tactile stimulus is near orthogonal (less than 30 degrees deviation) to the mucosal surface and unobstructed by salivary forces. The percentage of participants with LAR will be reported

The PAS is a widely-used ordinal scale metric used to describe severity of aspiration. The PAS score is multidimensional, i.e., include several observations within each score: (1) depth of airway invasion (material above, contacting, or below the level of vocal folds; (2) whether or not there is material remaining after the swallow (ejected, not ejected); and (3) the patient's response to material present in the airway (effort to clear the material). The PAS is an 8-point ordinal scale, with a total score ranging from 1 representing the least and 8 representing the highest or most severe score.

The PRLS is defined as a binary response to participants' self-reported detection of laryngeal stimulation. Once the participant indicates they perceived the stimulus, the research team will ask the participant to provide a perceptual strength rating on a 1-10 scale, with higher scores indicated a greater strength of stimulus.

Percentage of participants with visualized laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus will be recorded by the clinician and reported.

National Spasmodic Dysphonia Association

University of California, San Francisco

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)

Laryngeal Neoplasms

Hypopharyngeal Neoplasms

Respiratory Tract Neoplasms

Laryngeal Cancer

Hypopharyngeal Cancer

The study subjects will undergo enhanced contact endoscopy

The study subjects will undergo enhanced contact endoscopy - studied imaging technique

Enhanced contact endoscopy

The study subjects will undergo narrow band imaging - comparator procedure

Narrow band imaging

The study subjects will undergo IMAGE1S imaging - comparator procedure

IMAGE1S imaging

Jiří Hynčica

Peter Kántor, MD

Lucia Staníková, MD,Ph.D.

Karol Zeleník, Assoc.Prof.,MD,Ph.D.,MBA

Pavel Komínek, Prof.,MD,Ph.D.,MBA

Anna Švejdová, MD

The focus of the study is to verify the role of enhanced contact endoscopy in early identification of high-risk vascular patterns of precancerous and malignant mucosal changes in ear-nose-throat (ENT) patients, in comparison with other standard imaging techniques.

Endoscopy methods are inseparable part in diagnostics of patients with head and neck cancer. Nowadays ENT surgeons are offered a wide variety of endoscopy methods. The methods that caused revolution in early diagnostics of head and neck cancer were advanced imagining endoscopy methods such as NBI or IMAGE1S.

The new only recently introduced method is enhanced contact endoscopy, which uses a combination of advanced imagining, such as NBI or IMAGE1S, with rigid microlaryngoscope. It is believed that this technology has the potential to visualise vascular patterns of precancerous and malignant mucosal changes even better than narrow-band imaging (NBI) and IMAGE1S. This improvement in diagnostics helps with early identification of high-risk lesions and moves us closer to the concept of pre-histological diagnostics, which helps to accelerate making final diagnosis, which leads to prompt treatment.

Study protocol:

* anamnestic questionnaire (age, sex, weight, height, smoking, alcohol, reflux disease)
* Reflux Symptom Index (RSI) questionnaire
* endoscopy in white light in local anaesthesia with evaluation:
* character of the lesion (benign, Reinke edema, cyst, polyp, chronic laryngitis/pharyngitis, leukoplakia, erythroplakia, malignity)
* bleeding or ulceration on the surface of the lesion
* endoscopy with NBI endoscope in local anesthesia with evaluation:
* mucosa vascularization according to the ELS classification
* size of the lesion in compare to endoscopy in white light in local anesthesia
* occurrence of new lesions in compare to endoscopy in white light in local anesthesia
* endoscopy in white light in general anesthesia during microlaryngoscopy
* character of the lesion (benign, Reinkes edema, cyst, polyp, chronic laryngitis/pharyngitis, leukoplakia, erythroplakia, malignity)
* bleeding or ulceration on the surface of the lesion
* size of the lesion in compare to endoscopy in white light in local anesthesia
* occurence of new lesions when compared with endoscopy in white light in local anesthesia
* endoscopy in NBI or IMAGE1S in general anesthesia during microlaryngoscopy
* mucosa vascularization according to the ELS classification
* size of the lesion in compare to endoscopy in white light in local anesthesia
* occurence of new lesions in compare to endoscopy in white light in local anesthesia
* enhanced contact endoscopy (ECE) in NBI or IMAGE1S in general anesthesia during microlaryngoscopy
* mucosa vascularization according to the ELS and Puxxedu classification
* size of the lesion in compare to endoscopy in white light and NBI/ IMAGE1S in general anesthesia
* occurence of new lesions in compare to endoscopy in white light and NBI/

IMAGE1S in general anesthesia

* histology examination with determination of final diagnosis
* benign lesion
* mild dysplasia
* severe dysplasia
* carcinoma in situ
* invasive cancer

The study subjects will be enrolled into one study group.

Benefit of Enhanced Contact Endoscopy in Pre-histological Diagnosis of Laryngeal and Hypopharyngeal Mucosal Lesions

Determination of Diagnostic Benefit of Enhanced Contact Endoscopy (ECE) in Pre-histological Diagnosis of Laryngeal and Hypopharyngeal Mucosal Lesions

There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

The accuracy of enhanced contact endoscopy will be observed (size of lesions in mm when compared with the other standard techniques)

The sensitivity of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.

The specificity of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.

The positive predictive value of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.

The negative predictive value of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.

University Hospital Ostrava

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
CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions	NCT03214835	Laryngeal Disea... Laryngeal Tumor Laryngopharynge...	Endo CDx Brush ...	18 Years -	CDx Diagnostics
CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions	NCT03214835	Laryngeal Disea... Laryngeal Tumor Laryngopharynge...	Endo CDx Brush ...	18 Years -	CDx Diagnostics
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)
Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort	NCT06078527	Presbylarynx Aspiration Spasmodic Dysph... Globus Pharynge... Larynx Paralysi... Laryngeal Disea... Vocal Cord Para... Iatrogenic Inju... Sensory Neuropa...	Cheung-Bearelly... Transnasal Lary... Questionnaires	18 Years - 85 Years	University of California, San Francisco
CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions	NCT03214835	Laryngeal Disea... Laryngeal Tumor Laryngopharynge...	Endo CDx Brush ...	18 Years -	CDx Diagnostics
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)
Benefit of Enhanced Contact Endoscopy in Pre-histological Diagnosis of Laryngeal and Hypopharyngeal Mucosal Lesions	NCT04777474	Laryngeal Disea... Laryngeal Lesio... Hypopharyngeal ... Suspected Laryn... Suspected Hypop... Proven Laryngea... Proven Hypophar...	Enhanced contac... Narrow band ima... IMAGE1S imaging	18 Years -	University Hospital Ostrava
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 laryngeal disease