Stereotactic ABlative Radiotherapy (SABR) in Oligometastatic Cancer (OC): a Radiomics, Multi-omics, and Machine Learning Approach to Clinical Decision-making. the OC-SABR Multicentric Project
Data Collection
Urogenital Diseases+29
+ Genital Diseases
+ Breast Diseases
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: December 1, 2022
Actual date on which the first participant was enrolled.Metastases are the most threatening challenge in cancer. In patients with metastatic cancer, local radiotherapy treatment remains an essential tool with different goals that depend on numerous factors, especially on the number and extent of the metastases and whether disease control is feasible and desirable according to the expected quality of life. Oligometastatic Cancer (OC), i.e., a few metastases in a few organs, has been recently incorporated as a less aggressive state than widely disseminated metastatic disease. Consequently, OC is a serious candidate for aggressive treatments based on Stereotactic ABlative Radiotherapy (SABR). This treatment has shown promising results and is already incorporated into habitual clinical practices. However, OC is a complex and heterogeneous disease, and not all patients have improved their life quality and expectation. Identifying patients who would benefit from this treatment is an important area of research that needs factual information from a large sample provided by multiple centers. Therefore, this multicenter, retrospective, prospective, observational, and longitudinal study incorporates clinical data, medical images, and biological samples to feed artificial intelligence algorithms. The objective is to determine which patient profile achieves complete response after SABR. The secondary objectives are: 1. To analyze metastases by radiomics using computed tomography, magnetic resonance, or positron emission tomography images; and 2. To evaluate intratumoral metabolites released into circulation by multi-omics analyses. These will contribute to determining the systemic molecular effects of treatment in search of biomarkers with predictive value. Centralized storage of patient management data, clinical image analysis, and candidate biomarkers measured in blood samples may eventually meet the expectations of integrating data into clinical decision-making and influence evolution based on precision medicine.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.2000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Histologic confirmation of primary tumor: breast, prostate, lung, colorectal. * 18 years old or older. * Up to five metastases located in the bone, lung, node, liver or brain. * Eastern Cooperative Oncology Group (ECOG) Performance Status Scale 0 or 1. Exclusion Criteria: * Non-melanoma skin cancer. * Previous radiotherapy in the same anatomic location. * Presence of vascular collagen disease. * Pregnancy or lactation at the time of inclusion.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 21 locations
Hospital Universitari Sant Joan de Reus
Reus, SpainOpen Hospital Universitari Sant Joan de Reus in Google MapsComplejo Hospitalario Universitario Albacete
Albacete, SpainFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, SpainHospital Universitari Vall d'Hebron
Barcelona, Spain