Biological Collection on Emerging Infectious Diseases and Their Treatments (COMETE)
A Biological Sample Collection Established to Support Pathophysiological Research on Emerging and Potentially Emerging Infectious Diseases, as Well as Their Therapeutic Management.
Unprecedented changes in human-environment interactions and increasing disruptions to ecosystems and the climate have contributed to the emergence of infectious diseases (Emerging Infectious Diseases, EIDs). Advances in the treatment of cancers, malignant haematological disorders and immune-mediated inflammatory diseases are also contributing to the creation of new infectious risks among immunocompromised patient populations.
The COVID-19 pandemic has shown that structuring research prior to any outbreak is essential for the rapid implementation of responses to the emergence of an EID. The unpredictability of an EID's occurrence necessitates the planning of research projects in advance. A key element in this planning is the development of a collection of biological samples, providing a structured and immediately deployable resource for conducting pathophysiological and therapeutic research aimed at:
- Analyze the biological determinants of the microbe and the resulting infection
- Develop new tools for identification and characterization
- Study the factors (biomarkers/signatures) associated with individual patient susceptibility and response to treatment (personalized medicine)
- Understand the pathophysiology of infection to identify new targets for diagnostic, curative and preventive treatment
- Monitor the efficacy of curative and preventive treatments
Přehled studie
Postavení
Detailní popis
COMETE consists in a prospective monocenter longitudinal non-interventional study allowing the collection of biological samples from individuals or patients investigated in the context of an emerging infectious disease or one at risk of emergence due to exposure or suggestive symptomatology, whether the infection is ultimately ruled out or confirmed, and whether or not they have received curative or preventive treatment for this infection.
Visits: The initial visit (inclusion) and follow-up visits will take place as part of the patient's routine care, assessing their disease status or the curative or preventive treatment received during either hospitalization or a consultation. During these visits, biological samples will be collected when sampling is planned as part of the care (for verification, suspicion, diagnosis, or monitoring), and then throughout the follow-up period as part of the care plan.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Guillaume MARTIN-BLONDEL, MD, PhD
- Telefonní číslo: 33 +33561779699
- E-mail: martin-blondel.g@chu-toulouse.fr
Studijní záloha kontaktů
- Jméno: Béatrice PIGNOLET, PhD
- Telefonní číslo: 33 +33561779975
- E-mail: pignolet.b@chu-toulouse.fr
Studijní místa
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Toulouse, Francie, 31059
- University Hospital Toulouse
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Kontakt:
- Guillaume MARTIN-BLONDEL, MD, PhD
- Telefonní číslo: 33 +33561779699
- E-mail: martin-blondel.g@chu-toulouse.fr
-
Kontakt:
- Béatrice PIGNOLET, PhD
- Telefonní číslo: 33 +33561779975
- E-mail: pignolet.b@chu-toulouse.fr
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Patients aged 18 years or over
- Patients or individuals who have been exposed, are at risk of exposure, or are at risk of complications if exposed, or who are suspected of having, or are diagnosed with, an infectious disease considered to be emerging or at risk of emerging
- Patients receiving, or likely to receive, innovative treatments for the infection (new therapeutic molecules, checkpoint inhibitors, cell therapies, etc.)
- Patients or individuals receiving, or likely to receive, vaccines or other preventive therapeutic strategies
- Pregnant and breastfeeding women may be included.
Exclusion Criteria:
- Patients under a legal guardianship arrangement (guardianship, curatorship or court-ordered guardianship)
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Subjects presenting with emerging or potentially emerging infectious diseases
Biological samples will be collected in the normal diagnosis and follow-up process (only blood will be collected in larger quantity)
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Collection of biological samples and associated data from patients at risk of acquiring, or affected by, emerging or potentially emerging infectious diseases, including those receiving preventive or curative treatment for such infections
Časové okno: through study completion, an average of 1 year
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Prospective collection of all available biological and clinical-biological-imaging data collected during the usual clinical care
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through study completion, an average of 1 year
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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To improve our understanding of the pathophysiology of infection in order to identify new biomarkers for diagnostic and prognostic purposes, with a view to improving the management of emerging infectious diseases or those at risk of emerging
Časové okno: through study completion, an average of 1 year
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Identification of biomarkers using collected biological samples obtained from patients for cohort studies with various methods (flow cytometry, -omics, …)
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through study completion, an average of 1 year
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Identify new therapeutic targets for curative or preventive treatments
Časové okno: through study completion, an average of 1 year
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Identification of therapeutic targets using collected biological samples obtained from patients for cohort studies with various methods (flow cytometry, -omics, …)
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through study completion, an average of 1 year
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At the pathogen level: Analyse the biological determinants of the microbe and the resulting infection
Časové okno: through study completion, an average of 1 year
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Identification of biological determinants of the microbe and the resulting infection using collected biological samples with various methods of screening (PCR, qPCR, sequencing, metagenomics)
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through study completion, an average of 1 year
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At the pathogen level: Develop new tools for identification and characterisation
Časové okno: through study completion, an average of 1 year
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Use of the biological samples obtained from patients for using new and innovative methods of screening (PCR, qPCR, sequencing, metagenomics)
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through study completion, an average of 1 year
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At the host level: Identification and/or validation of associated or predictive biomarkers
Časové okno: through study completion, an average of 1 year
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Use of collected biological samples obtained from patients for cohort studies with various methods (flow cytometry, -omics, …)
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through study completion, an average of 1 year
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Guillaume MARTIN-BLONDEL, MD, PhD, University Hospital, Toulouse
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- RC31/25/0195
Informace o lécích a zařízeních, studijní dokumenty
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