Reengineering Cervical Cancer Screening for the 21st Century: Joint Action for a Novel Up-to-date and Sustainable Screening Program
A legfontosabb adatok
- Ki végzi
- Instituto de Saude Publica da Universidade do Porto
- Hol
- Vila Nova de Gaia (Portugália)A helyszín megnézése
- Azonosító
- Állapot
- Csak meghívásos
- Résztvevők
- 5700 fő, tervezett
- Kezdés
- 2025. ápr. 10.
- Várható befejezés
- 2027. márc. 31.
- A vizsgálat típusa
- Beavatkozással járó, 3 csoport
- A vizsgált kezelések
- Invitation of all participants to CCS according to the standard of care (active comparator)
- Invitation of all participants to CCS through self-sampling
- Invitation of all participants to CCS, asking them to choose between self-sampling and the standard of care
- Invitation of all participants to CCS according to the standard of care, followed by invitation of those non-adherent to CCS through self-sampling
- Invitation of all participants to CCS through self-sampling, followed by invitation of those non-adherent to CCS according to the standard of care
- Invitation of all participants to CCS, asking them to choose between self-sampling and the standard of care; this mode of invitation is repeated when participants do not adhere to the first invitation
- A regiszteradat frissítve
- 2025. április 23.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat 30 és 69 év közötti nőket keres, akiknek a portugál országos szűrőprogram szerint méhnyakrák-szűrésre van szükségük. Azt vizsgálja, hogyan lehet a szűrésben a saját maguk által levett mintát használni.
- Életkor
- 30 és 69 év között
- Nem
- Csak nők
A részvétel fő kizáró okai
- Nincs portugál mobiltelefonszám vagy portugál lakcím az egészségügyi egység nyilvántartásában
- Bármely olyan ok, amely a jelenlegi portugál szűrési irányelvek szerint kizárja a méhnyakrák-szűrést
A regiszter feltételei, szó szerint
Mind a 3 feltétel megnézéseKevesebb
Ki vehet részt
- Females fulfilling the eligibility criteria for CCS, as defined by the current guidelines for the organized screening program in Portugal
Ki nem vehet részt
- Not having a Portuguese mobile phone number or a Portuguese address available in the clinical/administrative records of the primary healthcare units
- Any of the exclusion criteria for CCS, as defined by the current guidelines for the organized screening program in Portugal
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 30 és 69 év között vagy?
Helyszínek itt: Portugália
- Unidade Local de Saúde Gaia e EspinhoVila Nova de Gaia, PortugáliaCsak meghívásos
A vizsgálatról
Mit akar kideríteni a vizsgálat
Cervical cancer screening (CCS) is important to prevent and control cervical cancer (CC). In Portugal, CCS starts with the assessment of the presence of Human Papillomavirus (HPV) in cervical-vaginal samples, collected by a health professional. However, self-sampling (self-collection of vaginal samples by the participants in CCS), is being considered in several settings, aiming to improve participation in CCS, while also exploring its potential to reduce costs.
A teljes eredeti leírásKevesebb
The goal of this study is to learn how self-sampling could be introduced in the CCS program in Portugal, by testing different strategies to combine the self-collection of samples with the collection of samples by a health professional, which is currently the standard of care.
Researchers will conduct a study comparing the following ways of conducting CCS:
* Sample collection by health professionals - SOC; * Self-sampling - SS; * Asking the participants if they prefer to collect their own samples, or to have the samples collected by a health professional, and then proceed as they prefer - CHOICE.
After assessing the adherence to CCS in each of the groups define above, the participants will be given the possibility to participate through a method different from the initially proposed or chosen, as follows:
* SOC will be complemented with invitation for SS; * SS will be complemented with invitation for the SOC; * CHOICE participants will be invited again to CHOICE, being given a new opportunity to choose how they prefer to be screened.
This study design allows for comparisons between these groups, to understand how using these strategies alone and complementarily works, and also for comparisons within each group, to understand how one strategy being used on the top of the previous may contribute to increase adherence to screening. The researchers will additionally collect information of the adherence to CCS in the year before the study is conducted, to be used as an additional benchmark.
For a better understanding on the potential barriers and facilitators to incorporating self-sampling in the CCS program, this study will also comprise interviews with the health professionals involved in the study, as well as with females eligible for screening who had been invited to participate.
Depending on the results of HPV testing and complementary cytological evaluations, participants may be referred for further assessment, according to the standard of care in the Portuguese National Health Service. This study will address the possibility of improving the yielding of the referral for further assessment, by testing, in parallel to the current standard of care, a method that is expected to contribute to reducing the number of referrals of false-positives.
Therefore, this study is expected to provide evidence based on different methods of assessment, showing the extent to which SS may contribute to improve adherence do CCS, and testing new methods that may reduce the referral of false-positives for further assessment.
A vizsgálat 3 csoportja
- Standard of care (followed by self-sampling for the non-adherent) - SOC+SSEgyéb csoport
CCS screening according to the standard of care (sample collected by a health professional). Participants not adhering will be subsequently invited to perform self-sampling for screening. When considering only the initial use of the SOC for CCS, this corresponds to arm type "active comparator". When considering the use of the SOC, followed by SS for participants not adhering to CCS according to the SOC, this corresponds to arm type "experimental".
Kezelés: Invitation of all participants to CCS according to the standard of care (active comparator) és Invitation of all participants to CCS according to the standard of care, followed by invitation of those non-adherent to CCS through self-sampling
- Self-sampling (followed by the standard of care for the non-adherent) - SS+SOCA vizsgált kezelés
CCS screening by self-sampling. Participants not adhering will be subsequently invited for screening according to the standard of care (sample collected by a health professional).
Kezelés: Invitation of all participants to CCS through self-sampling és Invitation of all participants to CCS through self-sampling, followed by invitation of those non-adherent to CCS according to the standard of care
- Choice (2x) between CCS through sample collected by health professional and self sampling - CHOICEx2A vizsgált kezelés
Participants will be asked for their preference for CCS through sample collected by a health professional or by self-sampling, and will undergo CCS accordingly. Those not adhering will be invited again to choose between one of the two methods of CCS.
Kezelés: Invitation of all participants to CCS, asking them to choose between self-sampling and the standard of care és Invitation of all participants to CCS, asking them to choose between self-sampling and the standard of care; this mode of invitation is repeated when participants do not adhere to the first invitation
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
- Illeszkedési kérdések
- Forrás: NCT06915610: ki vehet részt
- A regiszteradat frissítve
- 2025. április 23.