Completed

NCT Number: NCT02851420

Spectrometry of Cancerous Lesions of the Oral Cavity

The detection of suspect lesions is based on the clinical examination of the oral cavity and pharyngolaryngeal endoscopy, but the examination to confirm the diagnosis is a pathology examination of the biopsy taken during the endoscopy. Taking the biopsy, however, can be difficult. On the one hand , it is an invasive procedure, and may engender complications, and on the other hand, certain modifications of the mucosa may be discrete, or not particularly specific or, on the contrary, disseminated or extremely widespread.

Non-invasive tools to help the diagnosis could prove to be particularly interesting 1) to restrict the use of biopsies to patients in whom it is really necessary 2) and to identify the area where the biopsy should be done in cases of multiple lesions. In this context, spectroscopy could be a promising alternative.

The investigator puts forward the hypothesis that cancerous and precancerous lesions of the mucosa of the upper airways and digestive tract present a characteristic spectrometric profile. Indeed, as malignant tumours are hypervascularized and as precancerous tumours show signs of angiogenesis, investigators expect that the reflectance of haemoglobin will be diminished in the specific wavelengths of 540 and 575 nm, corresponding to the principal wavelengths absorbed by haemoglobin.

This pilot study will make it possible to construct an algorithm that could be used to classify lesions of the upper airways and digestive tract as either seemingly benign or cancerous.

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Key information

Conditions

Cancerous Lesions of the Oral Cavity

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patient - Patients consulting at the oto rhino laryngology department of Dijon for a functional symptom of the mouth, pharynx or larynx (pharyngeal discomfort, odynophagia, dysphagia, dysphonia, laryngeal dyspnoea) and in whom the clinical examination reveals a suspect lesion of the oral cavity, the pharynx or larynx and imposes an endoscopy procedure under general anaesthesia (unless it is a lesion of the tonsils or lingual tonsils)

Subjects who have provided consent
Subjects over 18 years old

volunteers:- Volunteers

Absence of risk factors cancerous oro-pharyngeal lesions, that is to say, non-smokers, alcohol consumption < 1 glass per day.
Absence of functional oto rhino laryngology symptoms (dyspnoea, dysphagia, dysphonia, pain)
Subjects who have provided consent
Subjects over 18 years old

Exclusion criteria

patient :- Patients without national health insurance cover

Pregnant or breast-feeding women
Biopsies not feasible

because of difficulty of exposure of the tumour
tumour not accessible to the biopsy forceps,
complications during the procedure making it impossible to do the biopsies (difficulties with ventilation)
Spectrometry not feasible

If exposure is difficult, tumour not accessible to the spectrometry probe (for example, a hypopharyngeal tumour in a patient with limited mouth opening)
In cases of anaesthesia complications, such as difficulties with ventilation
Lesions of the tonsils or lingual tonsil, suggesting lymphoma (exclusion of lymphoid tumours)

volunteers:- Persons without national health insurance cover

Pregnant or breast-feeding women
Presence of risk factors: alcohol-smoking
Presence of oto rhino laryngology functional symptoms

Treatment and study plan

spectroscopy

Other

Primary outcomes

Reflectance spectrum of haemoglobin

Time frame: Day one

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Interest of Spectroscopy in the Diagnosis of Cancerous and Precancerous Lesions of the Upper Airways (UA): Pilot Study

Acronym: SpectrORL1

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Aug 1, 2016
Registry last updated: Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.