Cohort profile: APCaRI Registry and Biorepository facilitates technology translation to the clinic through the use of linked, longitudinal clinical and patient-reported data and biospecimens from men in Alberta, Canada

Vasquez C, Kolinsky M, Djebah R, Uhlich M, Donnelly B, Fairey AS, Hyndman E, Usmani N, Wu J, Venner P, Ruether D, Todd G, Chetner M, Crump RT, Beatty PH, Lewis JD. Cohort profile: the Alberta Prostate Cancer Research Initiative (APCaRI) Registry and Biorepository facilitates technology translation to the clinic through the use of linked, longitudinal clinical and patient-reported data and biospecimens from men in Alberta, Canada. BMJ Open. 2020 Oct 16;10(10):e037222. doi: 10.1136/bmjopen-2020-037222. PMID: 33067276; PMCID: PMC7569975

Purpose: The Alberta Prostate Cancer Research Initiative (APCaRI) Registry and Biorepository was established in 2014 by the APCaRI to facilitate the collection of clinical and patient-reported data, biospecimen, to measure prostate cancer outcomes and to support the development and clinical translation of innovative technologies to better diagnose and predict outcomes for patients with prostate cancer.

Participants: Men suspected with prostate cancer and referred to Urology centres in Alberta were enrolled in the APCaRI 01 study, while men with a prior prostate cancer diagnosis participated in the APCaRI 03 study from 1 July 2014 to 30 June 2019. The APCaRI Registry and Biorepository links biospecimens and data from a wide representation of patients drawn from an Alberta population of more than 4 million.

Findings to date: From 1 July 2014 to 30 June 2019, total APCaRI 01 and 03 study recruitment was 3754 men; 142 (4%) of these men withdrew in full, 65 men (2%) withdrew biospecimens and 123 men (3%) died of any cause. Over this same time, 8677 patient-reported outcome measure (PROM) surveys and 7368 biospecimens were collected and are available from the registry and biorepository, respectively. The data entry error rate was 0.8% and 0.95% for critical and non-critical values, respectively, and 1.8% for patient-reported surveys.

Future plans: The APCaRI Registry and Biorepository will collect longitudinal data and PROM surveys until 2024, patient outcomes up to 25 years after recruitment and biospecimen storage for up to 25 years. The APCaRI cohorts will continue to provide data and samples to researchers conducting retrospective studies. The richness of the data and biospecimens will complement many different research questions, ultimately to improve the quality of care for men with prostate cancer.

Keywords: Biorepositories; Cohort Profile; OutcomeMeasures; Patient Reported; Prostatic Neoplasms; Registries; Studies; Surveys and Questionnaires; Translations.

ClarityDX Prostate clinical study expanding to the United States

Oct 8, 2019: APCaRI and Nanostics Inc. are excited to announce the opening of the first recruitment site in the US for the ClarityDX Prostate clinical validation study with Century Clinical Research Inc., based in Daytona Beach, Florida. ClarityDX Prostate is a novel liquid biopsy test for the early diagnosis of clinically significant prostate cancer.

The clinical validation study targets the recruitment of 2,800 patients with elevated levels of PSA. Therefore, US recruitment will significantly accelerate the clinical study timeline and increase patient cohort diversity.

Funding support to include US patients comes from the Bird Dogs for Prostate Cancer Research, Alberta Cancer Foundation, Alberta Innovates-ASBIRI program and the University of Alberta. The US and Canadian study samples will continue to be processed in partnership with DynaLIFE Medical Labs in Edmonton, Alberta.

“We’re very happy to partner with Century Clinical Research to recruit US men to our study,” John Lewis, CEO of Nanostics said, “the Florida recruitment site will help us increase the regional diversity of our cohort and strengthen the results of our ClarityDX Prostate study, ultimately, allowing us to make the test available to men across North America.”

“Our extensive clinical trial research experience and diverse patient population in Daytona Beach makes us a perfect partner…” said Thomas Gaskin, Vice-President & CFO of Century Clinical Research, Inc., “we look forward to working with Nanostics to develop their ClarityDX Prostate test to help improve prostate cancer outcomes.”

Implementing ClarityDX Prostate may eliminate up to 600,000 unnecessary biopsies, 24,000 hospitalizations and up to 50% of unnecessary treatments for prostate cancer in North America. This equates to a projected $1.4B per year in cost savings to healthcare and a dramatic impact on the healthcare experience and quality of life for men.

About Century Clinical Research, Inc.
Century Clinical Research, Inc. has over ten years of clinical research experience in multiple specialties, including hematology and oncology. Our staff has completed numerous industry-sponsored clinical trials in phases II-IV and has an excellent track record in quality completion of critical trials. Century Clinical Research, Inc. offers a full research infrastructure and our research staff has been trained in electronic data capture with multiple sponsors. We use a computerized clinical research program for tracking study participation and regulatory documents.

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