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Sammenligning av selvinnsamling ved bruk av tørr sammenlignet med våte vattpinner for HPV-deteksjon (HPV)

15. september 2026 oppdatert av: Foundation for Innovative New Diagnostics, Switzerland

Klinisk studie for å sammenligne ytelsen til selvinnsamlede vaginale prøver transportert tørre til de som transporteres våte for påvisning av hrHPV-DNA for å screene for CIN2+-lesjoner

This study will compare the performance of self-collected vaginal swabs, transported without liquid media (dry swabs) and self-collected vaginal swabs, transported in liquid media (wet swabs) for detection of hrHPV DNA LBC as the reference standard.

Studieoversikt

Status

Suspendert

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Self-collected vaginal samples for high-risk human papillomavirus (hrHPV) DNA testing are a promising alternative cervical cancer screening method for women who are reluctant to undergo healthcare provider-collection of cervical samples. Transportation of self-collected vaginal samples using swabs stored in liquid media incur additional costs and might create testing barriers for women. Dry transport of samples has the advantage of lower cost and ease of handling. Evidence on comparisons between self-collected vaginal samples using the dry swab and those transported in liquid media is limited, particularly in low- and middle-income countries (LMICs). The effect of using dry swabs on HPV-DNA detection in LMICs needs to be determined.

This study will compare the performance of self-collected vaginal swabs, transported without liquid media (dry swabs) and self-collected vaginal swabs, transported in liquid media (wet swabs) for detection of hrHPV DNA using LBC and as reference standard.

Studietype

Observasjonsmessig

Registrering (Antatt)

1306

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kenya
    • Nairobi County
      • Nairobi, Nairobi County, Kenya, 00100
        • Kenya Medical Research Institute (KEMRI)

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

30 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Participants are eligible to be included in the study only if all of the inclusion criteria and none of the exclusion criteria indicated below apply.

Prospective approval of protocol deviations to recruitment and enrolment criteria, also known as protocol waivers or exemptions, are not permitted.

Beskrivelse

Inclusion Criteria: Inclusion criteria for participants screened and enrolled consecutively as they present at the clinical study site:

  • Sexually active adult females ≥30 years of age (≥25 years of age if HIV+) presenting for treatment at a facility with an abnormal cervical cancer screening result (abnormal cytology, visual inspection with acetic acid and/or colposcopy)
  • Able to understand scope of study
  • Able to provide written informed consent
  • Willing to provide all necessary samples

Exclusion Criteria:

  • Vaccinated for HPV
  • Pregnancy
  • Patient not willing or unable to provide the all three swab samples (self-collected dry and wet and HCW collected cervical swabs)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Cohort of sexually active adult females with an abnormal cervical cancer screening result.

Multi-center, prospective, paired, comparative diagnostic accuracy study To compare the performance of self-collected vaginal samples transported dry to those transported wet for detection of hrHPV DNA.

Interventions:

COPAN floq swab transported wet and dry evaluated on Roche COBAS and Cepheid Xpert HPV tests
Enhet: • COPAN Self-collection FLOQSwabs® (COPAN, Italy)

COPAN swabs evaluated on Roche COBAS and Cepheid Xpert PCRs

Andre navn:
  • COPAN Selvoppsamling FLOQSwabs® (COPAN, Italia) med 5 ml PreservCyt Solution (Hologic)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To compare the performance of self-collected vaginal dry swabs to self-collected vaginal wet swabs for detection of hrHPV DNA using PCR on health care provider-collected cervical samples as the reference standard.
Tidsramme: 6 Months

Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected vaginal dry swabs to self-collected vaginal wet swabs for detection of hrHPV DNA using PCR as the reference standard.
6 Months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Compare the performance of self-collected vaginal dry swabs to provider-collected cervical samples for detection of hrHPV DNA to screen for CIN2+ lesions using LBC as the reference standard.
Tidsramme: 6 Months

Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected vaginal dry swabs to provider-collected cervical samples for detection of hrHPV to screen for CIN2+ lesions using LBC on health care provider-collected cervical samples as the reference standard.
6 Months
Compare the performance of self-collected vaginal wet swabs to provider-collected cervical samples for detection of hrHPV DNA to screen for CIN2+ lesions using LBC as the reference standard.
Tidsramme: 6 Months

Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected vaginal wet swabs to provider-collected cervical samples for detection of hrHPV to screen for CIN2+ lesions using LBC on health care provider-collected cervical samples as the reference standard.
6 Months
Compare the performance of self-collected vaginal dry swabs to self-collected vaginal wet swabs for detection of hrHPV DNA to screen for CIN2+ lesions using LBC as the reference standard.
Tidsramme: 6 Months

Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected dry swabs to self-collected wet swabs for detection of hrHPV to screen for CIN2+ lesions using LBC on health care provider-collected cervical samples as the reference standard.
6 Months
Assess the acceptability of self-collection vs provider-collection methods for HPV testing amongst women and health care workers.
Tidsramme: 6 Months

Assessment of survey responses using descriptive statistics.
6 Months
Assess the usability of self-collection amongst women and to assess the usability of self-collection using vaginal dry swabs compared to self-collection using vaginal wet swabs and provider collection methods for HPV testing amongst health care workers.
Tidsramme: 6 Months

Assessment of survey responses using descriptive statistics.
6 Months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Foundation for Innovative New Diagnostics, Switzerland

Samarbeidspartnere

Kenya Medical Research Institute
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Frere Hospital, East London, South Africa

Etterforskere

  • Studieleder: Angela Muriuki, Foundation for Innovative New Diagnostics (FIND)

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. mai 2024

Primær fullføring (Faktiske)

18. november 2024

Studiet fullført (Antatt)

30. september 2026

Datoer for studieregistrering

Først innsendt

4. oktober 2023

Først innsendt som oppfylte QC-kriteriene

16. januar 2024

Først lagt ut (Faktiske)

19. januar 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • WH001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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