Each year in the United States, more than 15 million people undergo colonoscopy, and roughly one-quarter are surveillance procedures following removal of colon polyps. Despite how common these follow-up exams are, clinicians have long lacked strong evidence to guide one basic question: how soon is too soon for repeat colonoscopy, particularly for low-risk patients with one or two non-advanced adenomas, the most common abnormal finding.

Over the years, recommendations have varied widely, from no follow-up to repeat exams every three, five, or ten years. In the U.S., a five-year interval became common practice, even as newer guidelines suggested extending surveillance to seven or ten years. Most of these recommendations, however, were based on retrospective data rather than prospective, randomized trials – the kind of evidence needed to truly change clinical practice. That gap is what the FORTE trial aims to address.

Led nationally by Drs. Robert Schoen and Jeffrey Dueker in collaboration with the National Cancer Institute, NCORP (the National Community Oncology Research Program), and NRG Oncology, FORTE (Five- or Ten-Year Colonoscopy for 1–2 Non-Advanced Adenomatous Polyps) is designed to provide definitive guidance. The trial will enroll 9,500 participants who have had one or two non-advanced adenomas removed at an index colonoscopy and randomly assign them to surveillance at five and ten years, or at ten years alone.

“The question is not whether colonoscopies work—they do—but whether patients truly need them as often as we’ve assumed,” says Dr. Dueker. While colonoscopies are generally safe, they are not without risk, cost, or inconvenience. The goal, he explains, is to perform them when they are needed, not sooner.

FORTE is built for broad generalizability. Participants ages 45-69 will be followed for 11 years or longer, with enrollment spanning community and VA sites across the country. As of December 2025, more than 3,800 participants have enrolled at 87 geographically diverse locations. Innovations such as tele-consent, mobile blood collection, and remote electronic follow-up reduce barriers to participation and allow patients to enroll without traveling to major medical centers.

The potential impact is significant. If FORTE demonstrates that a 10-year surveillance interval is non-inferior to a five-year exam for low-risk patients, it could safely reduce tens of thousands of colonoscopies each year, sparing patients unnecessary procedures while freeing resources for screening and diagnostic exams. Just as importantly, it would provide rigorous evidence to guide practice.

The trial also challenges a common assumption among patients that finding any polyp automatically places them at high cancer risk. “That is the goal—not that you won’t die from cancer, but that you won’t get it,” Dr. Schoen notes.
Beyond surveillance intervals, FORTE includes research components that may inform future personalized, risk-based screening strategies, including genetic and microbiome analyses. And for many participants, the motivation extends beyond their own care. As Schoen explains, participation is meaningful because it contributes to public health and collective knowledge.

FORTE’s scale and success reflect more than a single study. They highlight what is possible when investigators are supported by strong infrastructure. Within the Department of Medicine, that foundation is provided by the Clinical Trials Support Office (CTSO), established in 2022 to help investigators move clinical research from concept to activation more efficiently.

Since its launch, the CTSO has expanded both its team and its capabilities, providing centralized expertise in study start-up, regulatory navigation, budgeting, and trial management. Working closely with faculty, division leaders, UPMC partners, and institutional offices, the CTSO has helped streamline processes that historically slowed trial activation, reducing barriers for investigators at every career stage.

The office has also prioritized communication, transparency, and access to shared resources. Through regular meetings, standardized templates, department-approved SOPs, and a growing online resource hub, the CTSO supports investigators and research teams across the full lifecycle of clinical trials. Ongoing initiatives, including implementation of OnCore and the EPIC Research Module, are further aligning departmental practices with industry standards while improving recruitment, compliance, and financial tracking.

FORTE illustrates how this infrastructure enables large, collaborative, practice-changing trials to succeed. Whether a study is prevention-focused or therapeutic, investigator-initiated or industry-sponsored, the CTSO exists to help faculty move ideas from concept to activation and to ensure that high-impact clinical research can thrive across the Department of Medicine.