An observational study in Acromegaly, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-01-17.
Sponsored by University Hospital, Clermont-Ferrand · Observational
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Among 37 studies in Acromegaly with a site in France — 1 open to participants now, 1 under way, 1 of them phase 3. Acromegaly · France.
Among the 37 studies in Acromegaly with a site in France, this one is the 8th largest by planned enrollment of the 10 observational ones that give a count, is one of 3 that started in 2016, is one of 10 observational ones, and was the 30th registered.
202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.
Browse Acromegaly studies →1 of the 37 studies in Acromegaly with a site in France is open now. Recruiting first, the newest first:
Debiopharm International SA · Sites in France, United States, Austria and 18 more countries
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 14 Acromegaly studies recruiting now, 7 (50%) set no upper age limit and 5 (36%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
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37 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 6 · Phase 3 11 · Phase 4 5
First in 2000; this study’s year is marked. 3 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 70 is below the median of 100 across 81 observational studies indexed under Acromegaly.
Median enrollment 100 across the 27 interventional studies, 163 across the 10 observational. Of the 32 that completed or were terminated, 15 (47%) have results posted.
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28 of 37 have an industry lead sponsor. The 10 most frequent:
University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
University Hospital, Clermont-Ferrand has 1 study filed under Acromegaly — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 37 studies in Acromegaly with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Context: Acromegaly is the rare condition (3 to 4 new cases per million per year) due to Growth Hormone (GH) overproduction by a somatotrope pituitary adenoma, resulting in Insulin Growth Factor 1 (IGF-1) excess. Consequently, many tissues of the organism become hypertrophied. Hypertrophy of gingival and dental tissues can lead to alteration of oral health. However, there are very few published data concerning oral impact of acromegaly.
Objective: To do the most accurate clinical and radiological state of oral manifestations in the series of prevalent acromegaly patients followed in the endocrinology service of the CHU of Clermont-Ferrand.
Context/ study relevance: Acromegaly is a rare condition (3 to 4 new cases per million per year) due to Growth Hormone (GH) overproduction by a somatotrope pituitary adenoma, resulting in Insulin Growth Factor 1 (IGF-1) excess. Consequently, a dysmorphic syndrome prevailing at the level of face and extremities progressively develops associated with potentially severe general manifestations (cardiovascular, respiratory and metabolic complications). Oral manifestations of acromegaly are not well known, there is very few published data on this topic and a controversy about the existence of a parodontal disease, i.e. the presence of gingival sulcus deepening which can lead to tooth loss. IGF-1 excess could lead to gingival hypertrophy and then to gingival sulcus deepening. Otherwise, the dental cementum, the only dental tissue which can grow during all lifetime, could be influenced by an excess of IGF-1. It is likely that acromegaly is associated with pathological cementum hypertrophy.
Objective: To do the most accurate clinical and radiological state of oral manifestations in the series of prevalent acromegaly patients followed in the endocrinology service of the CHU of Clermont-Ferrand. Investigator will take a special interest in parodontal status i.e. the state of supporting tissues of the teeth and structural anomalies of dental cementum.
As secondary objective, investigator would make a histological characterization of gingival and dental (cementum) tissues when a surgical treatment of the oral condition is required. Investigator will search hypertrophic anomalies linked with GH/IGF-1 excess.
Material and methods: This is an observational, descriptive, cross-sectional, monocentric study conducted in the endocrinology/diabetology service of Clermont-Ferrand University Hospital (CHU), in France, where a series of about 70 prevalent acromegaly patients is annually followed. The participants will be adult acromegaly patients followed in this service, with proven diagnosis of acromegaly or previous acromegaly. They will be excluded of the study if they are totally toothless, if they take a medication associated with gingival hypertrophy if they are in a medical or chirurgical condition interacting with oral health so that the oral evaluation is not reliable or if there is no possibility of written informed consent. For each participant, investigator will collect demographic data and history of the pathology including previous and actual complications, biological tests results, imaging exams results and treatments. The participants will answer 3 questionnaires: AcroQol (quality of life in acromegaly patients), GOHAI (General Oral Health Assessment Index) and EPICES (evaluation of precariousness). The primary outcome will be a quantitative assessment of the oral health of the acromegalic patients with detailed assessment of 3 criteria:
The secondary outcome will be the histological analysis of gingival and dental tissues if available.
All these measures will be taken during a routine odonto-stomatological consultation, part of the annual pathology evaluation at the endocrinology/diabetology service.
acromegalic patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients with a proven diagnosis of acromegaly achieved by an IGFA assay and a GH measure.
Other: Oral manifestations
To do the most accurate clinical and radiological state of oral manifestations in the series of prevalent acromegaly patients followed in the endocrinology service of the CHU of Clermont-Ferrand.
oral health of acromegal patients
the periodontal status would be determinate by measuring the depth of gingival sulcus with a graduated periodontal probe on the four dental faces (mesial, distal, vestibular and lingual), on each tooth present in the mouth.
Time frame: at day 1 (during the odonto-stomatological consultation)
study of the dental cementum
the thickness of dental cementum would be measured on orthopantomogram. This characteristic could determinate the presence or not of hypercementosis
Time frame: at day 2 (24h after receipt of sample)
Determinate the CAO index
The CAO index could be determinate by counting the number of teeth with cavity or obturation or missing
Time frame: at day 2 (24h after receipt of sample)
Analysis of pathological gingival tissues
: if a gingival hypertrophy is determinate, a gingivectomy will be carried out and the tissue will be sent to the Anatomo-pathology laboratory to determinate its histological characteristics
Time frame: at day 2 (24h after receipt of sample)
Started Dec 2016 (actual). Primary completion is estimated for Dec 2018, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand →