Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2022-12-01
2037-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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OC-SABR
Patients diagnosed with Oligometastatic Cancer (OC) that will receive Stereotactic ABlative Radiotherapy (SABR) that has been prescribed per clinical protocol.
To propose a diagnostic test to determine the viability of Stereotactic ABlative Radiotherapy (SABR).
Analyze clinical data, medical images and molecular circulating features to propose which variables serve to select the patients that will achieve complete response after SABR.
To propose a diagnostic test to determine the effectiveness of SABR.
Collect blood samples at five different time points before and after treatment and analyze circulating tumoral DNA, medical images, and metabolites to monitor the effect of SABR and its effectiveness.
To propose a diagnostic test for Oligometastatic Cancer (OC).
Analyze circulating tumoral DNA and metabolites from blood samples in search of the profile of OC.
Controls
Individuals who have never been diagnosed with cancer or oligometastasis.
To propose a diagnostic test for Oligometastatic Cancer (OC).
Analyze circulating tumoral DNA and metabolites from blood samples in search of the profile of OC.
Interventions
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To propose a diagnostic test to determine the viability of Stereotactic ABlative Radiotherapy (SABR).
Analyze clinical data, medical images and molecular circulating features to propose which variables serve to select the patients that will achieve complete response after SABR.
To propose a diagnostic test to determine the effectiveness of SABR.
Collect blood samples at five different time points before and after treatment and analyze circulating tumoral DNA, medical images, and metabolites to monitor the effect of SABR and its effectiveness.
To propose a diagnostic test for Oligometastatic Cancer (OC).
Analyze circulating tumoral DNA and metabolites from blood samples in search of the profile of OC.
Eligibility Criteria
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Inclusion Criteria
* 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
* Previous radiotherapy in the same anatomic location.
* Presence of vascular collagen disease.
* Pregnancy or lactation at the time of inclusion.
18 Years
ALL
No
Sponsors
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Hospital Ruber Internacional
OTHER
Hospital Universitario Rey Juan Carlos
OTHER
Quirón Madrid University Hospital
OTHER
Hospital de La Luz
OTHER
Institut Català d'Oncologia
OTHER
Hospital Arnau de Vilanova
OTHER
Hospital Universitari Sant Joan de Reus
OTHER
Hospital Universitario Virgen Macarena
OTHER
Hospital Universitario Reina Sofia de Cordoba
OTHER_GOV
Hospital General Universitario de Valencia
OTHER
Hospital Clínico Universitario de Valencia
OTHER
Complejo Hospitalario Universitario de Albacete
OTHER
Hospital de Terrassa
OTHER
Hospital Universitario Ramon y Cajal
OTHER
Hospital del Mar
OTHER
Hospital Provincial de Castellon
OTHER
Hospital de la Santa creu i Sant Pau - Barcelona
OTHER
HM Sanchinarro University Hospital
OTHER
Hospital Miguel Servet
OTHER
University Hospital Virgen de las Nieves
OTHER
Hospital Vall d'Hebron
OTHER
Institut Investigacio Sanitaria Pere Virgili
OTHER
Responsible Party
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Principal Investigators
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Meritxell Arenas, PhD.
Role: STUDY_DIRECTOR
Universitat Rovira i Virgili, Hospital Universitari Sant Joan de Reus
Locations
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Complejo Hospitalario Universitario Albacete
Albacete, Albacete, Spain
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
Institut Català d'Oncologia
Barcelona, Barcelona, Spain
Hospital Universitario Virgen de las Nieves
Granada, Granada, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Lleida, Spain
Hospital de La Luz
Madrid, Madrid, Spain
Hospital Ruber Internacional
Madrid, Madrid, Spain
Hospital Universitario HM Sanchinarro
Madrid, Madrid, Spain
Hospital Universitario Quirónsalud
Madrid, Madrid, Spain
Hospital Universitario Rey Juan Carlos
Madrid, Madrid, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, Spain
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain
Hospital General Univesitario de Valencia
Valencia, Valencia, Spain
Hospital Universitari Miguel Servet
Zaragoza, Zaragoza, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Provincial de Castellón
Castellon, , Spain
Institut Català d'Oncologia
Girona, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital de Terrassa
Terrassa, , Spain
Countries
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Central Contacts
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Facility Contacts
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Sebastià Sabater
Role: primary
Jady Vivian Rojas
Role: primary
Victoria Reyes
Role: primary
Evelyn Martínez
Role: primary
Rosario Del Moral
Role: primary
Moisés Mira
Role: primary
Sofía Sanchez
Role: primary
Aurora Rodríguez
Role: primary
Ángel Montero
Role: primary
Elia Del Cerro
Role: primary
Stephanyie Payano
Role: primary
Carlos Míguez
Role: primary
Jordi Camps, PhD.
Role: backup
Andrea Jiménez-Franco, MSc.
Role: backup
Helena Castañé, MSc.
Role: backup
Cristian Martínez-Navidad, BSc.
Role: backup
Cristina Placed-Gallego, BSc.
Role: backup
Yolanda López, M.D.
Role: backup
David Gómez, M.D.
Role: backup
Jordi Trilla, M.D.
Role: backup
Mònica Arguís, M.D.
Role: backup
Mauricio Murcia, M.D.
Role: backup
Fredy Castaño, M.D.
Role: backup
Miguel Árquez, M.D.
Role: backup
Rocío Benavides, M.D.
Role: backup
Cecilia Escuín, M.D.
Role: backup
Olga Engel, M.D.
Role: backup
Johana Acosta, M.D.
Role: backup
Bárbara Malave, M.D.
Role: backup
David Calderón, M.D.
Role: backup
Víctor Hernández, PhD.
Role: backup
Ester Jordà
Role: primary
Amparo González
Role: primary
Reyes Ibáñez
Role: primary
Ismael Membrive
Role: primary
Carlos Ferrer
Role: primary
Arancha Eraso
Role: primary
Eva Fernández
Role: primary
Josep Maria Solé
Role: primary
Other Identifiers
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OC-SABR
Identifier Type: -
Identifier Source: org_study_id
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