Development of Clinical and Biological Database (BCBInstitut)
Development of a Monocentric and Prospective Clinical and Biological Database in Digestive Cancers, Gynecological Cancers, Breast Cancers and Sarcomas
The BCB is a tool:
- for research in analytical and public health epidemiology, biological research and for the development of data useful for clinical research and therapeutic trials;
- to help scientists understand and explain phenomena ranging from the interaction of molecules to the whole metabolism of the organism in normal and pathological situations;
- to identify potential strategies for prevention, diagnosis, management and analysis of cancer subtypes.
The creation of a broad clinical and biological prospective base dedicated to different types of cancer is essential for the development of such projects.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Implementation of a translational research project is part of the Cancer Plan 2014-2019 and its axis 5 "Advancing clinical and translational research in oncology", and more precisely Action 5.1.
The national health strategy launched by the Minister of Health and the Minister of Research will allow a better integration between research, innovation, medicine and care for the benefit of patients and society.
Moreover, knowledge of mechanisms involved in the phenomena of tumor invasion, metastatic dissemination, resistance to treatment and companion testing is crucial for the emergence of new biomarkers and therapeutic innovation.
However, the study of the earliest phases of tumorigenesis as well as of the advanced stages of the disease are currently limited by the low availability of blood and tissue samples combined with quality and reliable clinical data.
To meet these demands, the research must then integrate databases creation open to researchers and the ongoing evaluation of the impact of projects on the health of cancer patients.
Integrated research associated with quality biological research is the guarantee of medical progress.
The multidisciplinary structure around collections of biological resources will enable the various actors to harmonize not only the collection but also the sharing of their data with a view to making them available for medico-scientific projects at a regional and national dimension. The Clinical Biological Database (BCB) should be used to identify and characterize new molecular markers for better diagnosis and / or treatment. It should also permit to optimize the collection of all this information, their integration and their transversal exploitation by different research disciplines (epidemiological, fundamental, translational, clinical).
The BCB is a tool:
- for research in analytical and public health epidemiology, biological research and for the development of data useful for clinical research and therapeutic trials;
- to help scientists understand and explain phenomena ranging from the interaction of molecules to the whole metabolism of the organism in normal and pathological situations;
- to identify potential strategies for prevention, diagnosis, management and analysis of cancer subtypes.
The creation of a broad clinical and biological prospective base dedicated to different types of cancer is essential for the development of such projects
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: david azria
- Telefonnummer: +33467613102
- E-mail: david.azria@icm.unicancer.fr
Studiesteder
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Montpellier, Frankrig, 34298
- Rekruttering
- Institut regional du Cancer - Val d Aurelle
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Kontakt:
- BLEUSE Jean-pierre, MHD
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Ledende efterforsker:
- AZRIA David, PhD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age> at 18 years old,
- Patient with invasive or in situ tumor pathology (proven or suspected) any stage confounded,
Patient in ICM at diagnosis
- a digestive cancer (esophagus, stomach, pancreas, colon, rectum, anal canal) or
- gynecological cancer (ovary, endometrium, cervix) or
- breast cancer or
- sarcoma.
- Naïve patient of any treatment for the present cancer,
- Patient requiring treatment involving at least one (or more) tumor surgery (s)
- Patient who has accepted supplementary blood samples,
- Patient having given his informed, written and express consent.
Exclusion Criteria:
- Patient not affiliated to a social protection scheme,
- Patient whose regular follow-up is a priori impossible for psychological, familial, social or geographical reasons,
- Pregnant and / or nursing women,
- Subject under tutelage, curatorship or safeguard of justice,
- Patient in an emergency situation.
Studieplan
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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Eksperimentel: Biological collection
samples of different natures:
In parallel to this biological collection, standardized clinical data will be entered into a database |
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of patients who consent to participate in the study
Tidsramme: through study completion, an average of 1 year
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the proportion of patients who consent to participate in the study among the screened patients
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through study completion, an average of 1 year
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Quality of life assessment at baseline for all participants in the study
Tidsramme: through study completion, an average of 1 year
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Questionnaire assessment to measure the quality of life at baseline
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through study completion, an average of 1 year
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Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: jean pierre Bleuse, Institut Regional du Cancer de Montpellier
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ICM-URC2017/37
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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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