As part of AO Spine's effort to improve treatments of spinal tumors, the AO Spine Knowledge Forum (KF) Tumor conducts two clinical research registries: the Primary Tumor Research and Outcomes Network (PTRON) and the Metastatic Tumor Research and Outcomes Network (MTRON) registries. PTRON and MTRON have enrolled approximately 800 and 1200 patients, respectively. These two registries are among the world’s largest international prospective registries on spinal tumors and can provide answers to specific disease-related questions.
PTRON enrolled its first patient in May 2016, and MTRON, in September 2017. They have grown to include 16 (PTRON) and 25 (MTRON) study centers. It has costed an enormous amount of manpower and effort to ensure that the data collected are of high quality. But why is the AO Spine KF Tumor investing so much into these registries?
Physicians treating patients suffering from these conditions face multiple challenges in their effort to improve treatments and patients' quality of life. Oftentimes, oncologists and surgeons who conduct research only have access to a small number of patients which results in either inconclusive conclusions or conclusions that lack validity due the small sample sizes.
"Physicians treating patients suffering from these conditions face multiple challenges in their effort to improve treatments and patients' quality of life."
As the principal coordinating investigator for MTRON, Charles Fisher tells us, although other registries exist, they don't contain the data necessary to answer specific questions concerning spinal tumor treatments. By leveraging the global AO Spine network to recruit study centers that not only have high volume of spinal tumor patients but also the infrastructure to consent patients and monitor data collection, the AO Spine KF Tumor is in the unique position to conduct large registries such as PTRON and MTRON. As Larry Rhines tells, “We encourage broad participation; any interested center can be considered.”
Larry Rhines, a co-principal coordinating investigator for PTRON, further explains how PTRON and MTRON differ from other global registries: “People tend to want to collect every possible detail and your database very rapidly becomes unmanageable. We worked hard to decide what questions we wanted to answer.”
"We encourage broad participation; any interested center can be considered."
To answer these specific research questions, the PTRON and MTRON registries collect general data such as patient demographics, tumor types, and treatments, as well as specific information such as surgical margins, specific adverse events, specific health-related quality of life outcomes, and/or molecular profiles.
The AO Spine clinical research registries have been extremely successful and have produced several important clinical tools. PTRON and MTRON Principal Investigator, Ziya Gokaslan highlights that a spinal instability scoring system (SINS), an epidural spinal cord compression grading scale, and a quality-of-life assessment tool SOSGOQ2.0 (read more here)—all output from the studies and widely adopted by surgeons and oncologists. From the PTRON registry, a single nucleotide polymorphism has been identified that may be a prognostic biomarker for survival.
"The AO Spine clinical research registries have been extremely successful and have produced several important clinical tools."
Charles Fisher explains that registries often fail because they lack specific objectives or goals. In contrast, "AO Spine registries are highly successful because of two things: Our research registries are designed to have prospective studies embedded in them and our participating centers are well-informed of the specific objectives and goals and are excited about the study. They look forward to the results and want to have an impact on patient care." In addition, the high-quality data collected in AO Spine's registries enable retrospective use of data to answer questions that came up only after the registries have started.
As has been pointed out by Ziya Gokaslan and reiterated by Charles Fisher, the results of many of AO Spine KF's initiatives have been adopted worldwide by surgeons and medical and radiation oncologists and have benefited many patients. AO Spine looks forward to further news and results that emerge from PTRON and MTRON.
Read more about the AO Spine Knowledge Forum Tumor and their studies here.
PTRON ClinicalTrials.gov Identifier: NCT02790983
MTRON ClinicalTrials.gov Identifier: NCT02830451
Watch the video interview with Ziya Gokaslan, Charles Fisher, and Larry Rhines for more. The interview was recorded for AO TV during the AO Davos Courses in December 2020.
