Trial Title:
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01)
NCT ID:
NCT06498661
Condition:
Cervical Carcinoma
Human Papillomavirus Infection
Conditions: Official terms:
Papillomavirus Infections
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Masking description:
Samples will be shipped to BD-specified testing laboratories for blinded HPV testing as
per BD-specified frequency and stability information.
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of cervical samples by clinician
Arm group label:
Prevention (self-collected and clinician-collected samples)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Cervical Biopsy
Description:
Undergo cervical biopsy conducted by clinician
Arm group label:
Prevention (self-collected and clinician-collected samples)
Intervention type:
Procedure
Intervention name:
Colposcopy
Description:
Undergo colposcopy conducted by clinician
Arm group label:
Prevention (self-collected and clinician-collected samples)
Other name:
CP
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Prevention (self-collected and clinician-collected samples)
Intervention type:
Procedure
Intervention name:
Endocervical Curettage
Description:
Undergo endocervical curettage conducted by clinician
Arm group label:
Prevention (self-collected and clinician-collected samples)
Intervention type:
Procedure
Intervention name:
Excision
Description:
Undergo cervical excisional procedure conducted by clinician
Arm group label:
Prevention (self-collected and clinician-collected samples)
Other name:
Abscission
Other name:
Extirpation
Other name:
Surgical Removal
Intervention type:
Procedure
Intervention name:
HPV Self-Collection
Description:
Undertake self-collection of vaginal samples
Arm group label:
Prevention (self-collected and clinician-collected samples)
Other name:
At-home HPV Self Collection
Other name:
HPV Self Collection
Other name:
Human Papillomavirus Self-Collection
Intervention type:
Procedure
Intervention name:
Human Papillomavirus Test
Description:
Undergo HPV testing of self-collected vaginal samples and cervical samples
Arm group label:
Prevention (self-collected and clinician-collected samples)
Other name:
HPV Assay
Other name:
HPV Test
Other name:
Human Papillomavirus
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Prevention (self-collected and clinician-collected samples)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Prevention (self-collected and clinician-collected samples)
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.
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
precancer/cancer and agreement/concordance (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, HPV33/58, HPV35/39/68, HPV56/59/66.
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 biopsy/endocervical curettage and/or 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Is pregnant when presenting for the referral visit or gave birth within the past 3
months
- 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
- Has had a complete or partial hysterectomy, either supracervical or involving
removal of the cervix, via self-report or confirmation via medical records
- Known medical conditions that, in the opinion of the investigator, preclude study
participation
- Previous participation in the SHIP trial. Participation is defined as completing the
self-collection
- Is experiencing unusual bleeding or pelvic pain
Gender:
Female
Minimum age:
25 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama at Birmingham Cancer Center
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Warner K. Huh
Email:
whuh@uabmc.edu
Investigator:
Last name:
Warner K. Huh
Email:
Principal Investigator
Facility:
Name:
UCSF Medical Center-Parnassus
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
George Sawaya
Email:
george.sawaya@ucsf.edu
Investigator:
Last name:
George Sawaya
Email:
Principal Investigator
Facility:
Name:
Yale University
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sangini Sheth
Email:
sangini.sheth@yale.edu
Investigator:
Last name:
Sangini Sheth
Email:
Principal Investigator
Facility:
Name:
University of Miami Miller School of Medicine-Sylvester Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Erin Kobetz-Kerman
Email:
ekobetz@med.miami.edu
Investigator:
Last name:
Erin Kobetz-Kerman
Email:
Principal Investigator
Facility:
Name:
Emory University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lisa C. Flowers
Email:
lflowe2@emory.edu
Investigator:
Last name:
Lisa C. Flowers
Email:
Principal Investigator
Facility:
Name:
UofL Health Medical Center Northeast
Address:
City:
Louisville
Zip:
40245
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Tanya E. Franklin
Phone:
502-561-7463
Email:
tanya.franklin@louisville.edu
Investigator:
Last name:
Tanya E. Franklin
Email:
Principal Investigator
Facility:
Name:
Louisiana State University Health Science Center
Address:
City:
New Orleans
Zip:
70112
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Michael E. Hagensee
Email:
mhagen@lsuhsc.edu
Investigator:
Last name:
Michael E. Hagensee
Email:
Principal Investigator
Facility:
Name:
Johns Hopkins University/Sidney Kimmel Cancer Center
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Jenell S. Coleman
Email:
colemanj@jhmi.edu
Investigator:
Last name:
Jenell S. Coleman
Email:
Principal Investigator
Facility:
Name:
University of Michigan Comprehensive Cancer Center
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Diane M. Harper
Email:
harperdi@med.umich.edu
Investigator:
Last name:
Diane M. Harper
Email:
Principal Investigator
Facility:
Name:
Minneapolis VA Medical Center
Address:
City:
Minneapolis
Zip:
55417
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Elisheva Danan
Phone:
612-629-7517
Email:
elizabeth.danan@va.gov
Investigator:
Last name:
Elisheva Danan
Email:
Principal Investigator
Facility:
Name:
University of Mississippi Medical Center
Address:
City:
Jackson
Zip:
39216
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Carolann Risley
Phone:
228-217-2017
Email:
crisley@umc.edu
Investigator:
Last name:
Carolann Risley
Email:
Principal Investigator
Facility:
Name:
University of New Mexico Cancer Center
Address:
City:
Albuquerque
Zip:
87106
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Cosette M. Wheeler
Phone:
505-269-5817
Email:
cwheeler@salud.unm.edu
Investigator:
Last name:
Cosette M. Wheeler
Email:
Principal Investigator
Facility:
Name:
Montefiore Medical Center-Einstein Campus
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Mark H. Einstein
Email:
mark.einstein@einsteinmed.edu
Investigator:
Last name:
Mark H. Einstein
Email:
Principal Investigator
Facility:
Name:
NYP/Weill Cornell Medical Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Denise A. Howard
Email:
deh3002@med.cornell.edu
Investigator:
Last name:
Denise A. Howard
Email:
Principal Investigator
Facility:
Name:
UNC Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lisa Rahangdale
Email:
lisa_rahangdale@med.unc.edu
Investigator:
Last name:
Lisa Rahangdale
Email:
Principal Investigator
Facility:
Name:
University of Cincinnati Cancer Center-UC Medical Center
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Leeya F. Pinder
Email:
pinderl@ucmail.uc.edu
Investigator:
Last name:
Leeya F. Pinder
Email:
Principal Investigator
Facility:
Name:
Cleveland Clinic Foundation
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Miriam Cremer
Phone:
216-312-0618
Email:
cremerm@ccf.org
Investigator:
Last name:
Miriam Cremer
Email:
Principal Investigator
Facility:
Name:
University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Joan L. Walker
Email:
joan-walker@ouhsc.edu
Investigator:
Last name:
Joan L. Walker
Email:
Principal Investigator
Facility:
Name:
University of Pennsylvania/Abramson Cancer Center
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Carmen Guerra
Email:
carmen.guerra@pennmedicine.upenn.edu
Investigator:
Last name:
Carmen Guerra
Email:
Principal Investigator
Facility:
Name:
UPMC-Magee Womens Hospital
Address:
City:
Pittsburgh
Zip:
15213
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Harold C. Wiesenfeld
Phone:
412-641-1403
Email:
wieshc@upmc.edu
Investigator:
Last name:
Harold C. Wiesenfeld
Email:
Principal Investigator
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Elizabeth Y. Chiao
Phone:
713-792-1860
Email:
eychiao@mdanderson.org
Investigator:
Last name:
Elizabeth Y. Chiao
Email:
Principal Investigator
Facility:
Name:
Huntsman Cancer Institute/University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Theresa L. Werner
Email:
theresa.werner@hci.utah.edu
Investigator:
Last name:
Theresa L. Werner
Email:
Principal Investigator
Facility:
Name:
Virginia Commonwealth University/Massey Cancer Center
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Nicole W. Karjane
Email:
nicole.karjane@vcuhealth.org
Investigator:
Last name:
Nicole W. Karjane
Email:
Principal Investigator
Facility:
Name:
University of Washington Medical Center - Northwest
Address:
City:
Seattle
Zip:
98133
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Rachel L. Winer
Phone:
206-616-5081
Email:
rlw@uw.edu
Investigator:
Last name:
Rachel L. Winer
Email:
Principal Investigator
Facility:
Name:
University of Puerto Rico
Address:
City:
San Juan
Zip:
00936
Country:
Puerto Rico
Status:
Not yet recruiting
Contact:
Last name:
Ana P. Ortiz
Email:
ana.ortiz7@upr.edu
Investigator:
Last name:
Ana P. Ortiz
Email:
Principal Investigator
Start date:
June 26, 2024
Completion date:
March 14, 2025
Lead sponsor:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06498661
