- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07678528
Exposome, Pollutants, Biology in the Older Subject: EXPOSAGE (EXPOSAGE)
24. juni 2026 opdateret af: Centre Hospitalier Universitaire de Nice
Numerous factors, both individual and environmental, can influence aging, an individual's health, and their functional status.
However, the understanding of the combined impact of lifestyle-related exposures (e.g., physical activity, diet, sleep) (personal external exposome), exposures to pollutants (environmental external exposome), and their biological responses (internal exposome)-in other words, the impact of the "exposome" on healthy aging-remains limited, particularly in characterizing the molecular mechanisms associated with these interactions.
Exposome approaches identifying key exposures and molecular mechanisms could lead to a better understanding of how the environment, interacting with health behaviors, can affect functional status.
Thus, the objective of this study is i) to evaluate the links between the external exposome, the internal exposome and the health of older and aging individuals, and ii) to identify biological markers associated with a vulnerable health status in older and aging individuals.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
400
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Virginie PIOVANO
- E-mail: piovano.v@chu-nice.fr
Undersøgelse Kontakt Backup
- Navn: Olivier GUERIN, PROFESSOR
- Telefonnummer: 0492034194
- E-mail: guerin.o@chu-nice.fr
Studiesteder
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-
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Nice, Frankrig
- CHU de Nice - Hopital de Cimiez
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Ledende efterforsker:
- Olivier GUERIN, Pr
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Kontakt:
- Olivier GUERIN, Pr
- Telefonnummer: 0492034194
- E-mail: guerin.o@chu-nice.fr
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Aged 55 or over
- Affiliated with or beneficiaries of a social security scheme
- Signed the informed consent form •-Persons residing in one of the following municipalities : Antibes, Le Bar-sur-Loup, Berre-les-Alpes, Beuil, Blausasc, Breil-sur-Roya, Cabris, Cannes, Carros, Clans, Contes, Drap, L'Escarène, Escragnolles, Fontan, La Gaude, Gilette, Grasse, Lantosque, Levens, Nice, Peillon, Peymeinade, Saint-André-de-la-Roche, Saint-Etienne-de-Tinée, Sospel, Tourrettes-sur-Loup, Vence, Tende
Exclusion Criteria:
- patients currently undergoing intensive drug treatment, including chemotherapy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: Exposome assessment
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Visit 1: blood sample, questionnaires on the personal exposome (lifestyle habits (e.g., physical activity, diet, stress) and social characteristics and health status) | ii) Outpatient assessment: wearing a silicone bracelet for 7 days to measure external environmental exposure to pollutants and quantify physical activity | iii) Visit 2: 1-year follow-up of health status
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Frailty (health measure)
Tidsramme: at baseline and 12 months later
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Frailty is assessed using the Groningen Frailty Indicator.
The scale comprises 15 items.
The total score ranges from 0 to 25, with a higher score being worse.
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at baseline and 12 months later
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Functional and health status
Tidsramme: at baseline and 1 year
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Disease presence : : Presence (yes/no) of chronic disease
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at baseline and 1 year
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Physical functional capacities (health measure)
Tidsramme: at baseline and at 12 months
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Physical functional capacities are assessed using the Short Physical Performance Battery which assess balance, walking capacities and strength via a sit to stand test
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at baseline and at 12 months
|
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Quality of life (health measure)
Tidsramme: at baseline and 12 months
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Quality of life is assessed using the SF-12 questionnaire.
The scale comprises 12 items.
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at baseline and 12 months
|
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Autonomy (health measure)
Tidsramme: at baseline and 12 months
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Autonomy is assessed using the WHOQOL-OLD-AUT questionnaire.
The scale comprises 4 items.
The total score ranges from 4 to 20, with a higher score being better.
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at baseline and 12 months
|
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Comorbidity (health measure)
Tidsramme: at baseline and 12 months
|
Comorbidity is assessed using the Charlson Index which counts the number of comorbidities.
Higher score means greater number of comorbidities and therefore a poorer health.
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at baseline and 12 months
|
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Pollutant metabolites (internal exposome/biological measure)
Tidsramme: at baseline.
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Presence in the blood metabolome of molecules directly associated with pollutants (initial or biotransformed compounds).
This outcome will be obtained through a metabolomic analysis by very high-resolution mass spectrometry (consisting of the analysis of all small organic molecules (or metabolites)) performed on blood samples taken by a blood sampling.
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at baseline.
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DNA and telomere damage (internal exposome/biological measure)
Tidsramme: at baseline.
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DNA damage will be obtained through epigenetic analysis by studying miRNAs.
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at baseline.
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exposure to air pollutants (external environmental exposome measure)
Tidsramme: at baseline
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characteristics in terms of air pollution of the living space (quantity of fine particulate matter (PM), ozone (O3), nitrogen dioxide (NO2), or sulfur dioxide (SO2))
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at baseline
|
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exposure to pesticides, hydrocarbons, plastics, flame retardant pollutants (external environmental exposome measure)
Tidsramme: at baseline
|
the exposure will be obtained through a silicone bracelet worn for 7 days by the participant, which will allow the measure of all exposures in the person's daily life.
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at baseline
|
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Smoking habits (external personal exposome measure)
Tidsramme: at baseline.
|
smoking/non-smoking status identified via questionnaire.
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at baseline.
|
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Alcohol habits (external personal exposome measure)
Tidsramme: at baseline
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consumption volume identified via questionnaire.
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at baseline
|
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Self-reported physical activity habits (external personal exposome measure)
Tidsramme: at baseline
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volume of physical activity practice over a week identified via questionnaire.
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at baseline
|
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Objective-measured physical activity habits (external personal exposome measure)
Tidsramme: at baseline
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volume of physical activity practice over a week identified via actigraphy.
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at baseline
|
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Socioeconomic characteristic (external personal exposome measure)
Tidsramme: at baseline
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level of study identified via questionnaire.
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at baseline
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Socioeconomic characteristic (external personal exposome measure)
Tidsramme: at baseline
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socio-professional category identified via questionnaire.
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at baseline
|
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Psychological health (external personal exposome measure)
Tidsramme: at baseline
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anxiety assessed using the Hospital Anxiety and Depression Scale (HAD).
The scale comprises 14 items.
The total score ranges from 0 to 21, with a higher score being worse.
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at baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2030
Primær færdiggørelse (Anslået)
1. september 2031
Studieafslutning (Anslået)
1. september 2031
Datoer for studieregistrering
Først indsendt
11. juni 2026
Først indsendt, der opfyldte QC-kriterier
24. juni 2026
Først opslået (Faktiske)
1. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 25-PP-25
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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