Search / Trial NCT06611553

Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S02)

Launched by NATIONAL CANCER INSTITUTE (NCI) · Sep 24, 2024

Trial Information

Current as of October 08, 2024

Recruiting

Keywords

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 the Roche cobas HPV tests: Any high risk (HR) HPV genotype, HPV16, HPV 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 (combined). EXPLORATORY OBJECTIVE: I. To evaluate h...

Gender

FEMALE

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 cell 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 standard of care (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

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

New Haven, Connecticut, United States

Cleveland, Ohio, United States

Oklahoma City, Oklahoma, United States

Ann Arbor, Michigan, United States

Jackson, Mississippi, United States

Houston, Texas, United States

Salt Lake City, Utah, United States

Birmingham, Alabama, United States

Atlanta, Georgia, United States

Baltimore, Maryland, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Philadelphia, Pennsylvania, United States

Bronx, New York, United States

New Orleans, Louisiana, United States

Miami, Florida, United States

Richmond, Virginia, United States

San Francisco, California, United States

Minneapolis, Minnesota, United States

Cincinnati, Ohio, United States

Pittsburgh, Pennsylvania, United States

Albuquerque, New Mexico, United States

San Juan, , Puerto Rico

Seattle, Washington, United States

Louisville, Kentucky, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0