Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06611553 · ClinicalTrials.gov registry record · NA
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S02)
A NA study of Cervical Carcinoma and Human Papillomavirus Infection, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- NA
- Development phase
- 500
- Enrollment target
- 14
- Study locations
NCT06611553 is a NA study of Cervical Carcinoma and Human Papillomavirus Infection that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 500 participants, roughly in line with the 516-participant average among 25 other Cervical Carcinoma trials with a reported enrollment target. The trial reports 14 study locations across 13 states.
The verdict
NCT06611553, a NA study of Cervical Carcinoma and Human Papillomavirus Infection, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 500 participants
- Enrollment target
- 14
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Electronic Health Record Review
- PROCEDURE Cervical Biopsy
- PROCEDURE Colposcopy
- PROCEDURE Endocervical Curettage
Study Locations (14)
Pennsylvania
- University of Pennsylvania/Abramson Cancer Center - Philadelphia
- UPMC-Magee Womens Hospital - Pittsburgh
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Connecticut
- Yale University - New Haven
Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
Louisiana
- Louisiana State University Health Science Center - New Orleans
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Mississippi
- University of Mississippi Medical Center - Jackson
New York
- NYP/Weill Cornell Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2024-09-13 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06611553
The ClinicalTrials.gov registry entry for NCT06611553 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 516-participant average among 25 other Cervical Carcinoma trials with a reported enrollment target. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cervical Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06611553 reports 14 study locations spanning 13 distinct geographic areas - top geographies include Pennsylvania, Alabama, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06611553 about?
NCT06611553 is a clinical study titled "Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S02)". 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...
What is the current status of trial NCT06611553?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 500 participants. The study started on 2024-09-13. Estimated completion is 2026-12-31.
What conditions does trial NCT06611553 study?
This clinical trial studies the following conditions: Cervical Carcinoma, Human Papillomavirus Infection.
What interventions are being tested in trial NCT06611553?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Electronic Health Record Review (OTHER), Cervical Biopsy (PROCEDURE), Colposcopy (PROCEDURE), Endocervical Curettage (PROCEDURE).
Who is sponsoring clinical trial NCT06611553?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06611553 being conducted?
This trial has 14 study locations across Alabama, Connecticut, Florida, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cervical Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer
RECRUITING · NA
-
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04)
RECRUITING · NA
-
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01)
RECRUITING · NA
-
The Ohio State University (OSU) SCREEN Community Program
RECRUITING · NA
-
I Vaccinate: Testing Multi-Level Interventions to Improve HPV Vaccination
ACTIVE NOT RECRUITING · NA
-
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S03)
ACTIVE NOT RECRUITING · NA
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.