- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01588301
Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention (APACHE-2)
Attitudes to Different Strategies Among Women Not Attending Cervical Cancer Screening: Further Invitation by Mail or Kit for Self-collected Vaginal Sample
Scientific Context:
High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer. Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's well-known that this test has significantly contributed to the reduction of mortality and morbidity due to cervical cancer. In France, it now seems that the screening strategy could be optimized. The two main ways are to reach the 7 million underscreened women (organized screening, self-sampling for HPV DNA testing) and to improve the screening test (HPV DNA testing, computer-assisted cytology). Self-collected vaginal samples (SCVS) for HPV DNA testing could be a relevant screening option: this technique appears reliable and it could allow to reach women who are never or seldom screened. The performance of the SCVS to detect cervical HPV infection has been assessed by the first part of the whole study: APACHE-1.
The goal of this study is to compare the attitudes of women not attending organized cervical cancer screening face to different strategies: further invitation to make a cervical smear or kit for self-collected vaginal sample sent at home.
Description of the project :
Nine months after a primary invitation to make a cervical smear, a random sample of 6000 women not attending organized cervical cancer screening will be randomly assigned to one of the following arms:
- Intervention arm 1:
Women will receive a further invitation to make a cervical smear
- Intervention arm 2:
Women will be directly sent the kit for self-collected vaginal sample at home. The women who will send the self-sample to the laboratory for analyse will receive their results at home as well as their general practitioner if the HPV DNA test is positive (infection by a high-risk HPV).
For them who will have a HPV DNA test positive, it will be necessary to complete the screening action with a cervical smear. That's why those women will receive an invitation to make a cervical smear if they won't do it during the 9 months following the first mail.
- Control arm: Those women will receive complete information about the study, the main results and the screening recommendations at the end of the study.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Tidlig fase 1
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria :
- Women from 30 to 65 years
- Living in Indre-et-Loire (french territorial division 37)
Exclusion Criteria :
- Women who attend organized cervical cancer screening or who answer to the invitation
- Cervical smear made in the three last years
- HPV linked cervical condition undergoing treatment
- Hysterectomy (including cervix)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Group 1 : Further invitation by mail
Further invitation to attend for cervical cytology
|
A further invitation to attend for cervical cytology are going to be sent by mail to women
|
Eksperimentell: Group 2 : Kit for Self-collected vaginal sample
Kit for Self-collected vaginal sample sent at home and then test for Human Papillomavirus (HPV)
|
Kit for self-collected vaginal sample are going to be directly sent at women's home
|
Ingen inngripen: Group 3: Control
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Comparison of women's attitude according to the arm: participation or not to a whole screening action
Tidsramme: 9 months after the beginning of the study (sending of mails)
|
Comparison of attitudes among women not attending organized cervical cancer according to the type of intervention or the lack of intervention: participation or not to a whole screening action. Are considered as whole screening action:
|
9 months after the beginning of the study (sending of mails)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Analysis in sub-groups
Tidsramme: 9 months after the beginning of the study (sending of mails)
|
Analysis in sub-groups in order to compare the efficacy of interventions according to :
|
9 months after the beginning of the study (sending of mails)
|
Identification of the psychological determinants and mechanisms (checks and motivational factors)
Tidsramme: 9 months after the beginning of the study (sending of mails)
|
Identify the psychological determinants and mechanisms (checks and motivational factors) that can affect enrollment to the screening procedure for self-collection vaginal sample or cervical smear. Nine months after the beginning of the study, a questionnaire will be send to the 6000 women. |
9 months after the beginning of the study (sending of mails)
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Ken HAGUENOER, François Rabelais University, Public Health Laboratory, Tours, France
Studierekorddatoer
Studer hoveddatoer
Studiestart
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 (Anslag)
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
- INCA08-KH / APACHE-2
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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