The Compass Trial: Recognised as One of the Most Important Clinical Trials in 2023

Nature Medicine recently published an article featuring the “11 Clinical trials that will shape medicine in 2023”, which listed the top clinical trials to watch over the course of the year according to leading experts. The Compass Trial, a large-scale randomised controlled trial of Primary HPV DNA testing for cervical cancer in Australia, was included in this list.

Compass is the first major trial investigating cervical screening methods in a population with high rates of HPV vaccination, having recruited 81,000 women since 2013. This trial is co-led by C4 Chief Investigators Prof Karen Canfell at the Daffodil Centre and Prof Marion Saville at the Australian Centre for the Prevention of Cervical Cancer (ACPCC). Together, the trial has been conducted by the ACPCC and the Daffodil Centre, with close affiliations with the C4.

While cervical screening has traditionally used the Pap smear (cervical cytology) method, a more sensitive method which performs molecular testing to detect the presence of HPV is becoming more widely used, with Australia updating its cervical screening guidelines to HPV testing in 2017. In 2021, and with the support of modelling conducted by the Daffodil Centre, the World Health Organisation recommended HPV testing as the primary method for cervical screening. However, primary HPV screening has not yet been directly assessed in a highly vaccinated population.

The results from the Compass Trial are informing the national screening guidelines for the Australian program and safety monitoring of the primary HPV-based cervical screening program. Initial results from the Compass Pilot have already demonstrated increased detection of cervical precancerous lesions in a partially vaccinated population (1). Later this year, we expect to release results on the five-year follow-up from the pilot experience and on first round of HPV screening within the main trial. It is expected that these findings will provide key evidence to many countries around the world who are considering transitioning from cytology-based screening to primary HPV screening.

  1. Canfell K et al., PLoSMED 2018.

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