NCT06611540Fut, nem toboroz
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S03)
NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial LMI-001-A-S03
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 29.
Rövid összefoglaló (regiszter, angolul)
This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical excisional procedures to improve cervical cancer prevention. HPV is a common virus which usually causes infections that last only a few months, but sometimes can last longer. HPV is known to cause a variety of cancers including cervical cancer. Even though there are ways to detect cervical cancer, many individuals are not diagnosed. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. The low screening numbers show more testing needs to be done. Without appropriate screening and care, preventable precancer may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own sample for HPV testing to know their risk for cervical cancer. This may give individuals more flexibility and comfort having the ability to collect samples themselves, compared to a doctor performing a speculum examination and collecting the samples in a clinic. Information gathered from this study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician. The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is part of the National Cancer Institute (NCI)'s Cervical Cancer 'Last Mile' Initiative, a public private partnership that seeks to increase access to cervical cancer screening. The SHIP Trial focuses on developing clinical evidence to inform the US Food and Drug Administration (FDA)'s regulatory reviews of self-collection approaches as alternative sample collection approaches for cervical cancer screening. Several industry partner-specific self-collection device and assay combinations will be non-competitively and independently evaluated with a similar study design framework to inform pre-approval and/or post-approval regulatory requirements.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 500 (tervezett)
- Első benyújtás
- 2024. szept. 24.
- Kezdés
- 2024. szept. 11.
- Elsődleges befejezés
- 2026. dec. 30.
- Fő szponzor
- National Cancer Institute (NCI)
- Betegségek
- Méhnyakrák
- NCT-szám
- NCT06611540
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 500
- 2024. szept. 11. és az elsődleges befejezés (2026. dec. 30.) között
- 11 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- Has a known history of excisional or ablative therapy to the cervix (e.g., loop electrosurgical excision procedure [LEEP], cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the referral visit.
- Previous participation in the SHIP Trial. Participation is defined as completing the self-collection.
Más betegség
- Known medical conditions that, in the opinion of the investigator, preclude study participation.
- Is experiencing unusual bleeding or pelvic pain.
Egyéb
- Is pregnant when presenting for the referral visit or gave birth within the past 3 months.
- Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records.
Kiket keres a vizsgálat
- Willingness and ability to provide a documented informed consent.
- Is 25 years or older.
- Has an intact cervix.
- Has had a referral for colposcopy and/or cervical excisional procedure in which routine cervical cancer screening has included HPV testing (HPV primary screening, co-testing, or atypical squamous cells of undetermined significance [ASC-US] cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit.
- Willing and able to undergo colposcopy, and if clinically indicated for SOC purposes, a biopsy, endocervical curettage, and/or a cervical excisional procedure, as applicable.
Életkor a regiszterben: 25 év – - · Nem: csak nők · Egészséges önkénteseket is fogad
Helyszínek (11)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of New Mexico Cancer Center | Albuquerque | Egyesült Államok | Ismeretlen állapot |
| University of Michigan Rogel Cancer Center | Ann Arbor | Egyesült Államok | Ismeretlen állapot |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Egyesült Államok | Ismeretlen állapot |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | Egyesült Államok | Ismeretlen állapot |
| University of Cincinnati Cancer Center-UC Medical Center | Cincinnati | Egyesült Államok | Ismeretlen állapot |
| UT MD Anderson Cancer Center | Houston | Egyesült Államok | Ismeretlen állapot |
| UofL Health Medical Center Northeast | Louisville | Egyesült Államok | Ismeretlen állapot |
| Minneapolis VA Medical Center | Minneapolis | Egyesült Államok | Ismeretlen állapot |
| University of Pennsylvania/Abramson Cancer Center | Philadelphia | Egyesült Államok | Ismeretlen állapot |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Egyesült Államok | Ismeretlen állapot |
| Montefiore Medical Center-Einstein Campus | The Bronx | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.