Oligo-metastatic neoPlasms from the gastro-intestinal tract: iDentIfiCaTIon of cliNical and molecular drivers: the PREDICTION study

BMC Cancer

Study Protocol

Nicola Martucci¹  Renato Patrone¹  Antonello La Rocca¹  Giuseppe De Luca¹  Sara Santagata¹  Ugo Pace¹  Roberta Fusco¹  Giosuè Scognamiglio¹  Alessandra Sacco¹  Matilde Lambiase¹  Antonella Petrillo¹  Rossella Di Franco¹  Stefania Scala¹  Gerardo Ferrara¹  Anna Crispo¹  Andrea Belli¹  Vincenzo Ravo¹  Alessandro Ottaiano¹  Silvia De Franciscis¹  Annabella Di Mauro¹  Nicola Normanno¹  Egidio Celentano¹  Valentina Borzillo¹  Fabiana Tatangelo¹  Paolo Delrio¹  Guglielmo Nasti¹  Vincenza Granata¹  Daniela Castaldo¹  Piergiacomo Di Gennaro¹  Giuseppina Rea¹  Gianfranco De Feo¹  Daniela Rega¹  Paolo Muto¹  Antonella De Luca¹  Mariachiara Santorsola¹  Francesco Izzo¹  Edoardo Mercadante¹  Paolo Chiodini² 

[1] Istituto Nazionale Tumori, IRCCS “G. Pascale”, 80131, Napoli, Italy;Section of Statistics, Department of Mental Health and Public Medicine, Università degli Studi della Campania Luigi Vanvitelli, 80138, Napoli, Italy;

关键词: Oligometastatic diseases;    Colorectal cancer;    Biomarkers;    Genetics;    Prognosis;   

DOI  :  10.1186/s12885-023-11479-w

 received in 2023-07-05, accepted in 2023-10-04,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundMetastatic disease in tumors originating from the gastrointestinal tract can exhibit varying degrees of tumor burden at presentation. Some patients follow a less aggressive disease course, characterized by a limited number of metastatic sites, referred to as “oligo-metastatic disease” (OMD). The precise biological characteristics that define the oligometastatic behavior remain uncertain. In this study, we present a protocol designed to prospectively identify OMD, with the aim of proposing novel therapeutic approaches and monitoring strategies.MethodsThe PREDICTION study is a monocentric, prospective, observational investigation. Enrolled patients will receive standard treatment, while translational activities will involve analysis of the tumor microenvironment and genomic profiling using immunohistochemistry and next-generation sequencing, respectively. The first primary objective (descriptive) is to determine the prevalence of biological characteristics in OMD derived from gastrointestinal tract neoplasms, including high genetic concordance between primary tumors and metastases, a significant infiltration of T lymphocytes, and the absence of clonal evolution favoring specific driver genes (KRAS and PIK3CA). The second co-primary objective (analytic) is to identify a prognostic score for true OMD, with a primary focus on metastatic colorectal cancer. The score will comprise genetic concordance (> 80%), high T-lymphocyte infiltration, and the absence of clonal evolution favoring driver genes. It is hypothesized that patients with true OMD (score 3+) will have a lower rate of progression/recurrence within one year (20%) compared to those with false OMD (80%). The endpoint of the co-primary objective is the rate of recurrence/progression at one year. Considering a reasonable probability (60%) of the three factors occurring simultaneously in true OMD (score 3+), using a significance level of α = 0.05 and a test power of 90%, the study requires a minimum enrollment of 32 patients.DiscussionFew studies have explored the precise genetic and biological features of OMD thus far. In clinical settings, the diagnosis of OMD is typically made retrospectively, as some patients who undergo intensive treatment for oligometastases develop polymetastatic diseases within a year, while others do not experience disease progression (true OMD). In the coming years, the identification of true OMD will allow us to employ more personalized and comprehensive strategies in cancer treatment.Trial registrationClinicalTrials.gov ID NCT05806151.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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