Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Nasopharyngeal Neoplasms

Thyroid Neoplasms

Thyroid Diseases

Head and Neck Neoplasms

Nasopharyngeal Carcinoma

Mouth Neoplasms

Oropharyngeal Neoplasms

Salivary Gland Neoplasms

Laryngeal Diseases

Laryngeal Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine System Diseases

Endocrine Gland Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Respiratory Tract Diseases

Mouth Diseases

Salivary Gland Diseases

Respiratory Tract Neoplasms

Oral Cancer

Laryngeal Cancer

Hypopharyngeal Cancer

Lip and Oral Cavity Cancer

The aim is to differentiate between patients with head and neck cancer from those without based on a blood sample.

The aim is to identify recurrence through serial monitoring patients with blood samples.

The intervention is a liquid biopsy as a blood sample taken in a peripheral vein. The blood samples are analyzed for cell free DNA, RNA and HPV-DNA

Liquid biopsy

Christian Grønhøj, MD, Ph.D

Christian Von Buchwald, MD, DMSc

This study investigates if head and neck squamous cell carcinoma can be tracked with cell-free tumor DNA, RNA or HPV-DNA, in blood samples from patients referred with suspicion of cancer, and if it can be used in detecting recurrence in patients already diagnosed and treated for head and neck squamous cell carcinoma.

Cell-free Tumor DNA in Head and Neck Cancer Patients

Cell-free Tumor DNAand HPV-DNA in Blood Samples From Newly Diagnosed Patients With Head and Neck Cancer

The primary outcome is to measure the percentage of head and neck squamous cell carcinomas that can be detected using a liquid biopsy (blood sample)

The primary outcome is to measure the percentage of recurrence in head and neck cancer patients through serial monitoring with liquid biopsies (blood sample)

Copenhagen University Hospital, Denmark

Department of Otorhinolaryngology, Head and Neck Surgery and Audiology

Christian von Buchwald

Clinical Professor

Behaviors and Mental Disorders

Quality of Life

Oculocerebral Syndrome With Hypopigmentation

Patients who have undergone total laryngectomy and completed minimal their 12-month period without disease after surgery and post-operative treatments such as radiotherapy or chemotherapy

Filling out questionnaires, measuring maximum phonation and diadochokinesis

Quality of life questionnaire

Željka Laksar Klarić, M.D.

Andrijana Včeva, Prof., Ph.D.

Željka Laksar Klarić

Self-Evaluation of Communication Experiences after Laryngectomy (SECEL) questionnaire has been developed, with the aim of evaluating rehabilitation needs and the psychosocial care for patients with laryngeal cancer. This short but comprehensive self-report instrument measures the perceived adjustment to communication experiences and is intended to aid in determining counselling needs in patients with laryngeal cancer who are treated with a laryngectomy. The first aim of this study is to evaluate the translation, psychometric properties and cultural adaptation of a Croatian version of the SECEL questionnaire. Secondary aim is to examine relationship between the Croatian version of the SECEL and the Short Form Health Survey (SF-36) and the Voice Handicap Index (VHI) questionnaires and to examine relationship between objective voice measures and Self-Evaluation of Communication Experiences after Laryngectomy (SECEL:HR).

At the first visit all patients included in the study were asked to complete the Croatian version of the Voice Handicap Index (VHI), Short Form Health Survey (SF-36) and Self-Evaluation of Communication Experiences after Laryngectomy (SECEL:HR) questionnaire.

SECEL questionnaire consists of two parts. The first part examines the relevant general data on the person filling out the questionnaire, while the second part consists of 35 items questionably or statement-designed to examine communication experiences. Patients estimates the incidence of these communication difficulties on the Likert scale (0-never, 1-sometimes, 2-often, 3-always). 35 items are grouped according to 3 subscales named General (0-15 score range), Environment (0-42 score range) and Attitude (0-45 score range), and item number 35 is a separate question: "Do you talk the same amount now as before your laryngectomy?" and is rated with a "yes," "more," and "less" rating category. The overall numerical score varies from 0 to 102, and the higher score indicates greater difficulties and worse postoperative speech-communication adjustment.

The Voice Handicap Index (VHI) questionnaire consist of 30 items organized in three subscales functional, physical and emotional and also scored with Likert scale with overall score from 0 to 120. Higher scores indicate a greater handicap.

The Short Form Health Survey (SF-36) is a multi-purpose short-form health survey that consist of 36 questions divided in eight scales and clustered into two groups: physical and mental health. Each item was standardized (range 0-100), with a higher score representing better QoL.

The objective assessment includes the maximum phonation time measured in seconds as common clinical measure of glottal efficiency, diadochokinesis of the 3-syllable "pa-ta-ka" in 5 seconds (rated in syll/s) or how quickly subjects can produce a series of rapid sounds which is a measure of speech efficiency.

All patients will fulfil the SECEL:HR questionnaire twice, two weeks after the initial test and that will be considered as a re-test of the SECEL reliability analysis.

Validation and Cross-cultural Adaptation of Croatian SECEL Questionnaire

Validation and Cross-cultural Adaptation of Croatian Self-Evaluation of Communication Experiences After Laryngectomy Questionnaire

Completing the Croatian version of the SECEL questionnaire. Questionnaire consists of two parts. The first part examines the relevant general data on the person filling out the questionnaire, while the second part consists of 35 items questionably or statement-designed to examine communication experiences. Patients estimates the incidence of these communication difficulties on the Likert scale (0-never, 1-sometimes, 2-often, 3-always)

Completing the Croatian version of the Short Form Health Survey (SF-36) questionnaire. The Short Form Health Survey consist of 36 questions divided in eight scales and clustered into two groups: physical and mental health. Each item is standardized (range 0-100), with a higher score representing better QoL.

Completing the Croatian version of the Voice Handicap Index (VHI) questionnaire. The Voice Handicap Index (VHI) questionnaire consist of 30 items organized in three subscales functional, physical and emotional and scored with Likert scale (0-never, 1-almost never, 2-sometimes, 3-almost always, 4-always) with overall score from 0 to 120.

The maximum phonation time (measured in seconds) for which a person can sustain a vowel sound when produced on 1 deep breath at a comfortable pitch and loudness and is a common clinical measure of glottal efficiency.

The diadochokinesis measures how quickly an individual can accurately produce a series of rapid sounds of the 3-syllable "pa-ta-ka" in 5 seconds (rated in syll/s) and is a measure of speech efficiency.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cell-free Tumor DNA in Head and Neck Cancer Patients	NCT03942380	Head and Neck C... Head and Neck N... Head and Neck S... Oropharynx Canc... Oropharynx Neop... Oropharynx Carc... Oral Cavity Can... Oral Cancer Oral Neoplasm Larynx Cancer Larynx Carcinom... Larynx Neoplasm Nasopharyngeal ... Nasopharyngeal ... Nasopharynx Neo... Hypopharynx Can... Hypopharynx Neo... Hypopharynx Car... Sinonasal Carci... Thyroid Carcino... Thyroid Cancer Thyroid Neoplas... Salivary Gland ... Salivary Gland ... Salivary Gland ... Sinonasal Cance... Sinonasal Neopl...	Liquid biopsy	18 Years -	Rigshospitalet, Denmark
Validation and Cross-cultural Adaptation of Croatian SECEL Questionnaire	NCT05346237	Larynx Neoplasm Laryngectomy; S... Communication Quality of Life	Quality of life...	18 Years - 90 Years	Osijek University Hospital
Cell-free Tumor DNA in Head and Neck Cancer Patients	NCT03942380	Head and Neck C... Head and Neck N... Head and Neck S... Oropharynx Canc... Oropharynx Neop... Oropharynx Carc... Oral Cavity Can... Oral Cancer Oral Neoplasm Larynx Cancer Larynx Carcinom... Larynx Neoplasm Nasopharyngeal ... Nasopharyngeal ... Nasopharynx Neo... Hypopharynx Can... Hypopharynx Neo... Hypopharynx Car... Sinonasal Carci... Thyroid Carcino... Thyroid Cancer Thyroid Neoplas... Salivary Gland ... Salivary Gland ... Salivary Gland ... Sinonasal Cance... Sinonasal Neopl...	Liquid biopsy	18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for larynx neoplasm