Identification of High Risk People for Colorectal Cancer and Evaluation of a Specific Surveillance System (ISIRECC)
Identification of High Risk People for Colorectal Cancer in Indre-et-Loire (France) and Evaluation of a Specific Surveillance System : a Randomized Trial Assessing the Efficacy of a Letter Encouraging People to Perform Colonoscopy Screening
Colorectal cancer is one the most frequent cancer in developed countries. In France, it rank third with 43000 new cases in 2015. French Health Authority recommended colonoscopy screening for people with a high risk for colorectal cancer. But this compliance with colonoscopy is low (20-40%), it is therefore necessary to develop new strategies to improve compliance.
The purpose of this project is to to offer and evaluate the feasibility and the effectiveness of a specific surveillance system for high risk people for colorectal cancer
The project will be divided into 2 phases:
Objectives of the first phase:
- Identify high risk people for colorectal cancer in the department of Indre-et-Loire,
- Fill in as completely as possible their colonoscopic history in the past 5 years,
- Estimate the proportion of high risk people for colorectal cancer in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years).
Objective of the second phase:
Compare the performed colonoscopy rate of high risk people for colorectal cancer without notion of colonoscopy in the past 58 months following or not (control group) the sending of a letter reminding the importance of compliance with colonoscopy.
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Indre-et-Loire
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Tours, Indre-et-Loire, Frankrike, 37000
- UH Tours
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- residing in Indre et Loire (France)
- with increased risk for colorectal cancer
- who did not perform a colonoscopy in the past 58 months
Exclusion Criteria:
- none
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Reminder letter
A letter is sent for remind the importance of compliance with colonoscopy AND to encourage people to to consult their general practitioner or gastroenterologist (if they haven't done their follow-up in time).
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The letter will consist in several parts:
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Ingen inngripen: Control
No intervention (what is done currently)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Calculate the rate of high risk people for colorectal cancer identified in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years)
Tidsramme: one year
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one year
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Comparison of the performed colonoscopy rate within 12 months following randomization / send letter in the 2 arms
Tidsramme: 12 months after sending the letter (/randomization)
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12 months after sending the letter (/randomization)
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Somany SENGCHANH, Dr, Centre de Coordination des Dépistages des Cancers CHRU de Tours
- Hovedetterforsker: Ken HAGUENOER, Dr, Centre de Coordination des Dépistages des Cancers
- Hovedetterforsker: Julie Boyard, Centre de Coordination des Dépistages des Cancers
- Studiestol: Thierry Lecomte, Pr, CHRU de Tours, Service Hépato- gastroentérologie
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- INCa15-SS/ISIRECC
- 2015-A01607-42 (Annen identifikator: ID RCB)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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