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Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04)

RecruitingNAAges 25 Years - anyFemaleNational Cancer Institute (NCI)
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In plain words

What the trial is, and whether it could suit you

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 cerv

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 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, and/or for cervical excisional procedure * 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 or another cervical cancer screening study within the past 12 months. Participation is defined as completing the self-collection * Is experiencing unusual bleeding or pelvic pain
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What it tests

  • Biospecimen Collection
  • Cervical Biopsy
  • Colposcopy
  • Electronic Health Record Review
  • Endocervical Curettage
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Where

18 sites
University of Alabama at Birmingham Cancer Center
Birmingham, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, United States
Louisiana State University
Lafayette, United States
Louisiana State University Health Science Center
New Orleans, United States
Minneapolis VA Medical Center
Minneapolis, United States
University of New Mexico Cancer Center
Albuquerque, United States
Montefiore Medical Center-Einstein Campus
The Bronx, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, United States

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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