A new U.S. clinical trial will evaluate whether an at-home, self-collection technique to screen for cervical cancer is as accurate and effective as a Pap smear test done in a healthcare clinic. 

The Clinical Monitoring Research Program Directorate (CMRPD) at the Frederick National Laboratory for Cancer Research will coordinate the National Cancer Institute (NCI) study to be conducted at 25 sites.  

Women in low-income or underserved areas or who lack health insurance are at greater risk to develop cervical cancer and to die from the disease. At the same time, these women face barriers in getting to a clinic for a pelvic exam and pap test. 

The ‘Last Mile’ Initiative SHIP Trial will evaluate the usability, acceptability, accuracy, and effectiveness of an alternative approach to cervical cancer screening. SHIP stands for the Self-collection for HPV testing to Improve Cervical Cancer Prevention. 

While other countries have implemented the self-collection method, the U.S. Food and Drug Administration (FDA) is just now considering this tactic for at-home preventative care. The SHIP Trial will be done in collaboration with the FDA and support its regulatory requirements. 

Removing barriers to cervical cancer screening  

Most cervical cancers are caused by the human papillomavirus (HPV) and can be prevented by HPV vaccination and screening for and treatment of precancerous growths.  

The standard of care to screen for cervical cancer involves a visit to a clinic, a pelvic examination performed by a healthcare provider, and specimen collection. Knowing that barriers exist to receiving care, the trial will evaluate self-sampling techniques for HPV to help increase access to screening and reduce cervical cancer.  

“We are excited to play a role in improving public health interests through the coordination of this important clinical research study,” said Shelly Simpson, director of the CMRPD. “The study has the potential to eliminate inequities in health care and offer cervical cancer screening to individuals most at risk.” 

Expertise to support a comprehensive trial  

As the SHIP Trial’s Coordinating Center, CMRPD will provide full-service trial coordination across clinical enrollment sites and assist with the execution of all study-related activities from protocol development to study closure. 

Responsibilities of the coordinating center will include onboarding clinical enrollment sites, specimen kit coordination with industry partners, distribution of kits to study participants, specimen management and specimen repositories, data management, quality assurance monitoring, and overall compliance with research protocol. 

“CMRPD has launched many different studies and worked with different networks in the past, yet each study brings on its own unique elements and considerations,” said Erin Rudzinski, a clinical trials manager for CMRPD. “We are eager to support the Last Mile Initiative SHIP Trial.” 

CMRPD specializes in supporting clinical trials in domestic and international settings. The program coordinates clinical trials and research initiatives investigating the prevention, detection, and treatment of cancer, HIV/AIDS, influenza, and other infectious diseases such as Ebola virus, mpox, and COVID-19.    

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