Evaluation of the Geographical Accessibility of Genome-Matched Clinical Trials on a National Experience - Research Findings

Sep 21, 2026

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Molecularly driven oncology enables treatment selection based on a patient’s genomic profile, and clinical trials are a key route to access genome-matched therapies. This study examines geographical accessibility in Italy and how trial location affects patient enrollment. A retrospective case-series analysis used next-generation sequencing data from March 2019 to July 2020, linking actionable alterations to trials listed on ClinicalTrials.gov at report signature.

LanguageEnglish

CategoryResearch & Report

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Pages7

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Abstract

Background

Material and Methods

Results

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Implications for Practice

Introduction

Evaluation of the Geographical Accessibility of GenomeMatched Clinical Trials on a National Experience Edoardo Crimini1,2,‡, Giulia Tini1,‡, Paolo Tarantino1,2,3,4, Liliana Ascione1,2, Matteo Repetto1,2, Paolo Beria5, Alberto Ranghiero1, Antonio Marra1, Carmen Belli1, Carmen Criscitiello1,2, Angela Esposito1, Elena Guerini Rocco1,2, Massimo C.P. Barberis1, Luca Mazzarella1,\#, Giuseppe Curigliano*, 1,2,\#, 1Division of New Drugs and Early Drug Development for Innovative Therapies, European Institute of Oncology, IRCCS, Milan, Italy 2Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy 3 Breast Oncology Center, Dana-Farber Cancer Institute, Boston, MA, USA 4 Harvard Medical School, Boston, MA, USA 5Department of Architettura e Studi Urbani, Politecnico di Milano, Milan, Italy * Corresponding author: Giuseppe Curigliano, MD, PhD, Division of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, Via Giuseppe Ripamonti, 435, 20141 Milano MI, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy. Email: giuseppe. curigliano@ [ieo.it](ieo.it) ‡Contributed equally as first authors. \#Contributed equally as senior authors. Abstract Background: Molecular-driven oncology allows oncologists to identify treatments that match a cancer’s genomic profile. Clinical trials are promoted as an effective modality to deliver a molecularly matched treatment. We explore the role of geographical accessibility in Italy, and its impact on patient access to clinical trials. Material and Methods: We retrospectively reviewed molecular data from a single-institutional case series of patients receiving next-generation sequencing testing between March 2019 and July 2020. Actionable alterations were defined as the ones with at least one matched treatment on [Clinicaltrials.gov](Clinicaltrials.gov) at the time of genomic report signature. We then calculated the hypothetical distance to travel to reach the nearest assigned clinical trial. Results: We identified 159 patients eligible for analysis. One hundred and one could be potentially assigned to a clinical trial in Italy, and the median distance that patients needed to travel to reach the closest location with a suitable clinical trial was 76 km (interquartile range = 127.46 km) . Geographical distribution of clinical trials in Italy found to be heterogeneous, with Milan and Naples being the areas with a higher concentration. We then found that the probability of having a clinical trial close to a patient’s hometown increased over time, according to registered studies between 2015 and 2020. Conclusions: The median distance to be travelled to the nearest trial was generally acceptable for patients, and trials availability is increasing. Nevertheless, many areas are still lacking trials, so efforts are required to increase and homogenize the possibilities to be enrolled in clinical trials for Italian patients with cancer. Key words: cancer; clinical trials; precision medicine; target therapy; molecular tumor board; accessibility. Implications for Practice This study analyzed the geographical distribution of clinical trials for oncological patients on the Italian territory and the distance to be traveled to reach the nearest location in which the trial is active, aiming to assess if the latter could represent an obstacle for enrollment of patients with cancer, potentially impacting outcomes. It was found that many patients still have to travel for long distances to be enrolled, despite the fact that the availability of trials has increased in recent years. This work highlights the urgency of changing the paradigm of clinical trials management, and solutions are suggested to mitigate the economic, social, and logistic burden for patients. Introduction Despite great advancements in its diagnosis and treatment, cancer remains a leading cause of death worldwide.1 Expanding access to experimental treatment

FAQs

What was the study’s main focus regarding genome-matched oncology trials?

The study assessed how geographical accessibility in Italy influences patient access and enrollment for genome-matched clinical trials.

How were eligible patients and trials defined in the analysis?

Patients from a single-institution case series were included using next-generation sequencing results, and actionable alterations were defined by the presence of at least one matched treatment trial on ClinicalTrials.gov at the time of genomic report signature.

What distance-to-trial findings were reported for patients in Italy?

Of 159 analyzed patients, 101 could be assigned to a clinical trial in Italy. The median travel distance to the nearest suitable trial was 76 km, with a heterogeneous geographic distribution and higher concentration areas including Milan and Naples.

Sep 21, 2026

Uploaded by Himbo