Trial Title:
The Impact of Radiotherapy on Oligometastatic Cancer
NCT ID:
NCT05933876
Condition:
Metastasis
Metastatic Breast Cancer
Metastatic Prostate Cancer
Metastatic Colorectal Cancer
Metastatic Lung Cancer
Conditions: Official terms:
Neoplasm Metastasis
Conditions: Keywords:
Metastasis
Radiosurgery
Metabolomics
Radiomics
Multi-omics
Molecular subtypes
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
To propose a diagnostic test to determine the viability of Stereotactic ABlative Radiotherapy (SABR).
Description:
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.
Arm group label:
OC-SABR
Intervention type:
Diagnostic Test
Intervention name:
To propose a diagnostic test to determine the effectiveness of SABR.
Description:
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.
Arm group label:
OC-SABR
Intervention type:
Diagnostic Test
Intervention name:
To propose a diagnostic test for Oligometastatic Cancer (OC).
Description:
Analyze circulating tumoral DNA and metabolites from blood samples in search of the
profile of OC.
Arm group label:
Controls
Arm group label:
OC-SABR
Summary:
Metastases represent the most threatening challenge in cancer. One of the management
strategies for patients with Oligometastatic Cancer (OC) is Stereotactic ABlative
Radiotherapy (SABR). However, there are few studies, and there is no defined clinical
standard, nor are the radiobiological mechanisms that contribute to treatment response
well understood. The focus should be on generating evidence to guide the personalization
of radiotherapy beyond solely technological and anatomical precision. This could be
achieved by recollecting clinical and biological data from patients that undergo this
treatment and analyzing them to ultimately predict, with the help of artificial
intelligence, which patients will be the most beneficiary and improve their survival
rate.
Detailed description:
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.
Criteria for eligibility:
Study pop:
Patients attending the collaboration hospitals to receive Stereotactic ABlative
Radiotherapy (SABR) to treat Oligometastatic Cancer (OC).
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Hospital Universitari Sant Joan de Reus
Address:
City:
Reus
Zip:
43204
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Jorge Joven, Prof.
Phone:
+977310300
Phone ext:
55409
Email:
jorge.joven@urv.cat
Contact backup:
Last name:
Meritxell Arenas, PhD.
Email:
meritxell.arenas@urv.cat
Investigator:
Last name:
Jordi Camps, PhD.
Email:
Sub-Investigator
Investigator:
Last name:
Andrea Jiménez-Franco, MSc.
Email:
Sub-Investigator
Investigator:
Last name:
Helena Castañé, MSc.
Email:
Sub-Investigator
Investigator:
Last name:
Cristian Martínez-Navidad, BSc.
Email:
Sub-Investigator
Investigator:
Last name:
Cristina Placed-Gallego, BSc.
Email:
Sub-Investigator
Investigator:
Last name:
Yolanda López, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
David Gómez, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Jordi Trilla, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Mònica Arguís, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Mauricio Murcia, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Fredy Castaño, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Miguel Árquez, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Rocío Benavides, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Cecilia Escuín, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Olga Engel, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Johana Acosta, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Bárbara Malave, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
David Calderón, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Víctor Hernández, PhD.
Email:
Sub-Investigator
Facility:
Name:
Complejo Hospitalario Universitario Albacete
Address:
City:
Albacete
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Sebastià Sabater
Facility:
Name:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Address:
City:
Barcelona
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Jady Vivian Rojas
Facility:
Name:
Hospital del Mar
Address:
City:
Barcelona
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Ismael Membrive
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Victoria Reyes
Facility:
Name:
Institut Català d'Oncologia
Address:
City:
Barcelona
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Evelyn Martínez
Facility:
Name:
Hospital Provincial de Castellón
Address:
City:
Castelló de la Plana
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Carlos Ferrer
Facility:
Name:
Institut Català d'Oncologia
Address:
City:
Girona
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Arancha Eraso
Facility:
Name:
Hospital Universitario Virgen de las Nieves
Address:
City:
Granada
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Rosario Del Moral
Facility:
Name:
Hospital Universitari Arnau de Vilanova
Address:
City:
Lleida
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Moisés Mira
Facility:
Name:
Hospital de La Luz
Address:
City:
Madrid
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Sofía Sanchez
Facility:
Name:
Hospital Ruber Internacional
Address:
City:
Madrid
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Aurora Rodríguez
Facility:
Name:
Hospital Universitario HM Sanchinarro
Address:
City:
Madrid
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Ángel Montero
Facility:
Name:
Hospital Universitario Quirónsalud
Address:
City:
Madrid
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Elia Del Cerro
Facility:
Name:
Hospital Universitario Ramón y Cajal
Address:
City:
Madrid
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Eva Fernández
Facility:
Name:
Hospital Universitario Rey Juan Carlos
Address:
City:
Madrid
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Stephanyie Payano
Facility:
Name:
Hospital Universitario Virgen Macarena
Address:
City:
Sevilla
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Carlos Míguez
Facility:
Name:
Hospital de Terrassa
Address:
City:
Terrassa
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Josep Maria Solé
Facility:
Name:
Hospital Clínico Universitario de Valencia
Address:
City:
Valencia
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Ester Jordà
Facility:
Name:
Hospital General Univesitario de Valencia
Address:
City:
Valencia
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Amparo González
Facility:
Name:
Hospital Universitari Miguel Servet
Address:
City:
Zaragoza
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Reyes Ibáñez
Start date:
December 1, 2022
Completion date:
December 31, 2037
Lead sponsor:
Agency:
Institut Investigacio Sanitaria Pere Virgili
Agency class:
Other
Collaborator:
Agency:
HM Sanchinarro University Hospital
Agency class:
Other
Collaborator:
Agency:
Hospital Ruber Internacional
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario Rey Juan Carlos
Agency class:
Other
Collaborator:
Agency:
Quirón Madrid University Hospital
Agency class:
Other
Collaborator:
Agency:
Hospital de La Luz
Agency class:
Other
Collaborator:
Agency:
Institut Català d'Oncologia
Agency class:
Other
Collaborator:
Agency:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Agency class:
Other
Collaborator:
Agency:
Hospital Vall d'Hebron
Agency class:
Other
Collaborator:
Agency:
Hospital Arnau de Vilanova
Agency class:
Other
Collaborator:
Agency:
Hospital Universitari Sant Joan de Reus
Agency class:
Other
Collaborator:
Agency:
Hospital Miguel Servet
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario Virgen Macarena
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario Reina Sofia de Cordoba
Agency class:
Other
Collaborator:
Agency:
University Hospital Virgen de las Nieves
Agency class:
Other
Collaborator:
Agency:
Hospital General Universitario de Valencia
Agency class:
Other
Collaborator:
Agency:
Hospital Clínico Universitario de Valencia
Agency class:
Other
Collaborator:
Agency:
Complejo Hospitalario Universitario de Albacete
Agency class:
Other
Collaborator:
Agency:
Hospital de Terrassa
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario Ramon y Cajal
Agency class:
Other
Collaborator:
Agency:
Hospital del Mar
Agency class:
Other
Collaborator:
Agency:
Hospital Provincial de Castellon
Agency class:
Other
Source:
Institut Investigacio Sanitaria Pere Virgili
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05933876
