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| Name | Class |
|---|---|
| Hospital Ruber Internacional | OTHER |
| Hospital Universitario Rey Juan Carlos | OTHER |
| Quirón Madrid University Hospital | OTHER |
| Hospital de La Luz |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OC-SABR | Patients diagnosed with Oligometastatic Cancer (OC) that will receive Stereotactic ABlative Radiotherapy (SABR) that has been prescribed per clinical protocol. |
| |
| Controls | Individuals who have never been diagnosed with cancer or oligometastasis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| To propose a diagnostic test to determine the viability of Stereotactic ABlative Radiotherapy (SABR). | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological rate | Images obtained by computerized tomography, magnetic resonance and positron emission tomography serve to evaluate the local control and response rate by:
According to RECIST Criteria 1.1 and PERCIST. | 3 months after treatment |
| Progression-Free Survival | To assess the impact of SABR on the progression over time, precisely at 1, 2, 3, and 5 years, regarding Progression-Free Survival (PFS) based on RECIST Criteria 1.1 and PERCIST. | 5 years after treatment |
| SABR toxicities | To evaluate the progression of SABR toxicities over time, precisely at 1, 2, 3, and 5 years, according to the CTCAE 4.0 scale. | 5 years after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients attending the collaboration hospitals to receive Stereotactic ABlative Radiotherapy (SABR) to treat Oligometastatic Cancer (OC).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jorge Joven, Prof. | Contact | +34977310300 | 55409 | jorge.joven@urv.cat |
| Meritxell Arenas, PhD. | Contact | meritxell.arenas@urv.cat |
| Name | Affiliation | Role |
|---|---|---|
| Meritxell Arenas, PhD. | Universitat Rovira i Virgili, Hospital Universitari Sant Joan de Reus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario Albacete | Not yet recruiting | Albacete | Albacete | Spain |
The Data Management Plan makes data fully findable, accessible, interoperable, and reusable, following the indication of the Horizon 2024 initiative of the European Union. The clinical team identified sensitive data, including epidemiological, anthropometric, and medical information. It is the only responsibility of the principal investigator to ensure that sensitive data are de-identified, implementing technical safeguards to guarantee anonymity.
Most data will be experimental and obtained from the analysis of column value and data format description (.txt or .csv) and syntax scripts (.R).
The external collaborators, especially those involved in validation cohorts, may have access to data upon request.
With the acceptance of the principal investigator, Rovira i Virgili University's institutional service will guarantee digital access to repositories with raw data generated in research analyses.
Once decided the repository web address.
Decided by the principal investigator.
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| 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 |
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Plasma, serum, and DNA samples.
|
| To propose a diagnostic test to determine the effectiveness of SABR. | Diagnostic Test | 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). | Diagnostic Test | Analyze circulating tumoral DNA and metabolites from blood samples in search of the profile of OC. |
|
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Not yet recruiting | Barcelona | Barcelona | Spain |
|
| Hospital Universitari Vall d'Hebron | Not yet recruiting | Barcelona | Barcelona | Spain |
|
| Institut Català d'Oncologia | Not yet recruiting | Barcelona | Barcelona | Spain |
|
| Hospital Universitario Virgen de las Nieves | Not yet recruiting | Granada | Granada | Spain |
|
| Hospital Universitari Arnau de Vilanova | Not yet recruiting | Lleida | Lleida | Spain |
|
| Hospital de La Luz | Not yet recruiting | Madrid | Madrid | Spain |
|
| Hospital Ruber Internacional | Not yet recruiting | Madrid | Madrid | Spain |
|
| Hospital Universitario HM Sanchinarro | Not yet recruiting | Madrid | Madrid | Spain |
|
| Hospital Universitario Quirónsalud | Not yet recruiting | Madrid | Madrid | Spain |
|
| Hospital Universitario Rey Juan Carlos | Not yet recruiting | Madrid | Madrid | Spain |
|
| Hospital Universitario Virgen Macarena | Not yet recruiting | Seville | Sevilla | Spain |
|
| Hospital Universitari Sant Joan de Reus | Recruiting | Reus | Tarragona | 43204 | Spain |
|
| Hospital Clínico Universitario de Valencia | Not yet recruiting | Valencia | Valencia | Spain |
|
| Hospital General Univesitario de Valencia | Not yet recruiting | Valencia | Valencia | Spain |
|
| Hospital Universitari Miguel Servet | Not yet recruiting | Zaragoza | Zaragoza | Spain |
|
| Hospital del Mar | Not yet recruiting | Barcelona | Spain |
|
| Hospital Provincial de Castellón | Not yet recruiting | Castellon | Spain |
|
| Institut Català d'Oncologia | Not yet recruiting | Girona | Spain |
|
| Hospital Universitario Ramón y Cajal | Not yet recruiting | Madrid | Spain |
|
| Hospital de Terrassa | Not yet recruiting | Terrassa | Spain |
|
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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