NCT06498661Fut, nem toboroz

Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01)

NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial LMI-001-A-S01

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 29.

Következő lépések

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. It is known to cause a variety of cancers including cancer of the cervix. Even though there are ways to detect cervical cancer early, many individuals do not undergo screening that involves pelvic exams. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. Without appropriate screening and care, preventable pre-cancers may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own vaginal 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. 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: 750 (tervezett)
Első benyújtás: 2024. júl. 10.
Kezdés: 2024. jún. 26.
Elsődleges befejezés: 2026. dec. 30.
Fő szponzor: National Cancer Institute (NCI)
Betegségek: Méhnyakrák
NCT-szám: NCT06498661

Mit vállalsz

Vizsgálat típusa: Beavatkozással járó
Tervezett résztvevők: 750
2024. jún. 26. és az elsődleges befejezés (2026. dec. 30.) között
15 helyszín, 2 országban
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Korábbi kezelés

GROUP A: 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
GROUP A: Previous participation in the SHIP trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months
GROUP B: Has a known history of excisional or ablative therapy to the cervix (e.g., LEEP, cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the screening visit
GROUP B: Previous participation in the SHIP Trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months
GROUP B: Is experiencing any active vaginal infection or has used any vaginal products in 48 hours previous to study sample collection

Más betegség

GROUP A: Known medical conditions that, in the opinion of the investigator, preclude study participation
GROUP A: Is experiencing unusual bleeding or pelvic pain
GROUP B: Known medical conditions that, in the opinion of the investigator, preclude study participation
GROUP B: Is experiencing any bleeding (including menstruation) or pelvic pain

Egyéb

GROUP A: Is pregnant when presenting for the referral visit or gave birth within the past 3 months
GROUP A: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
GROUP B: Is known to be pregnant when presenting for the screening visit or gave birth within the past 3 months
GROUP B: 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

GROUP A: Willingness and ability to provide a documented informed consent
GROUP A: Is 25 years or older
GROUP A: Has an intact cervix
GROUP A: Has had a referral for colposcopy or cervical excisional procedure in which routine cervical cancer screening has included positive 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
GROUP A: 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
GROUP B: Willingness and ability to provide a documented informed consent
GROUP B: Is 25 years or older
GROUP B: Has an intact cervix
GROUP B: Eligible for regular cervical cancer screening by current national guidelines

Életkor a regiszterben: 25 év – - · Nem: csak nők · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (15)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

Helyszín	Város	Ország	Helyszín állapota
University of Puerto Rico	San Juan	Puerto Rico	Ismeretlen állapot
University of New Mexico Cancer Center	Albuquerque	Egyesült Államok	Ismeretlen állapot
Emory University Hospital/Winship Cancer Institute	Atlanta	Egyesült Államok	Ismeretlen állapot
Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Egyesült Államok	Ismeretlen állapot
University of Alabama at Birmingham Cancer Center	Birmingham	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
University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Egyesült Államok	Ismeretlen állapot
Louisiana State University Health Science Center	New Orleans	Egyesült Államok	Ismeretlen állapot
University of Oklahoma Health Sciences Center	Oklahoma City	Egyesült Államok	Ismeretlen állapot
University of Pennsylvania/Abramson Cancer Center	Philadelphia	Egyesült Államok	Ismeretlen állapot
UPMC-Magee Womens Hospital	Pittsburgh	Egyesült Államok	Ismeretlen állapot
VCU Massey Comprehensive Cancer Center	Richmond	Egyesült Államok	Ismeretlen állapot
Montefiore Medical Center-Einstein Campus	The Bronx	Egyesült Államok	Ismeretlen állapot

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