Ignite Creation Date:
2024-07-17 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498661
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-10
Brief Title:
Self-collection for HPV Testing to Improve Cervical Cancer Prevention SHIP Trial LMI-001-A-S01
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
NCI Cervical Cancer Last Mile Initiative Self-Collection for HPV Testing to Improve Cervical Cancer Prevention SHIP Trial LMI-001-A-S01
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHIP-A-S01
Brief Summary:
This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus HPV testing in patients referred for a colposcopy andor 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 NCIs 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 FDAs 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 andor post-approval regulatory requirements
The Self-collection for HPV Testing to Improve Cervical Cancer Prevention SHIP Trial is part of the National Cancer Institute NCIs 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 FDAs 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 andor post-approval regulatory requirements
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate clinical accuracy including clinical sensitivity clinical specificity false positive rate and false negative rate for the detection of cervical precancercancer and agreementconcordance including positive percent agreement and negative percent agreement on self-collected SC versus clinician collected CC samples for the following HPV genotype detections and groupings by Becton Dickinson and Company BD Onclarity trademark HPV assay Any high risk HR HPV genotype HPV16 HPV18 HPV31 HPV45 HPV51 HPV52 HPV3358 HPV353968 HPV565966
EXPLORATORY OBJECTIVE
I To evaluate human factors affecting usability acceptability and preferences for self-collection
OBJECTIVE FOR PILOT PHASE
I The emphasis in the pilot phase of the study will be on streamlining and refining study procedures and clinical and operational workflows
OUTLINE
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample Patients then undergo standard of care colposcopy with biopsyendocervical curettage andor cervical excisional procedures as clinically indicated
After completion of study intervention one time laboratory results available within 90 days are collected for study analysis purposes
I To evaluate clinical accuracy including clinical sensitivity clinical specificity false positive rate and false negative rate for the detection of cervical precancercancer and agreementconcordance including positive percent agreement and negative percent agreement on self-collected SC versus clinician collected CC samples for the following HPV genotype detections and groupings by Becton Dickinson and Company BD Onclarity trademark HPV assay Any high risk HR HPV genotype HPV16 HPV18 HPV31 HPV45 HPV51 HPV52 HPV3358 HPV353968 HPV565966
EXPLORATORY OBJECTIVE
I To evaluate human factors affecting usability acceptability and preferences for self-collection
OBJECTIVE FOR PILOT PHASE
I The emphasis in the pilot phase of the study will be on streamlining and refining study procedures and clinical and operational workflows
OUTLINE
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample Patients then undergo standard of care colposcopy with biopsyendocervical curettage andor cervical excisional procedures as clinically indicated
After completion of study intervention one time laboratory results available within 90 days are collected for study analysis purposes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-05879 | REGISTRY | None | None |
| LMI-001-A-S01 | OTHER | None | None |
| LMI-001-A-S01 | OTHER | None | None |