An observational study in Breast Cancer Early Stage Breast Cancer (Stage 1-3), sponsored by Parc de Salut Mar. Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Parc de Salut Mar · Observational
The Utility of Intraoperative Radiotherapy in Breast Cancer (RIOMA) is an observational project to understand the use and outcomes of intraoperative radiotherapy in patients with breast cancer under conditions of clinical use (not clinical trials). Intraoperative radiotherapy (IORT) is a technique that began to be used years ago, transferring the patient from the operating room to the radiotherapy suite. This technique therefore fell into disuse. The emergence of miniaturized linear accelerators has led to a resurgence of IORT, especially as part of conservative treatment in patients with breast cancer, both as a booster or as a sole treatment (partial breast irradiation).
This project is based on an online platform. Each participating center will be assigned access codes on the website to access and complete the coded clinical data for each patient treated with intraoperative radiotherapy. Data on tumor characteristics, the type of intraoperative radiotherapy, follow-up, complications, and cosmetic outcomes are included.
Primary objective:
To understand the characteristics of patients treated with intraoperative radiotherapy under routine clinical practice conditions.
The project is based on structured data collection in an electronic data collection notebook (using the OpenclinicaTM standard), relating to the care provided according to standard clinical practice in the Radiation Oncology, Gynecology and Surgery departments of the participating centers in Spain.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Parc de Salut Mar is the lead sponsor of 180 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with early breast cancer who are candidates for intraoperative radiotherapy, such as exclusive partial irradiation, anticipated boosting, or salvage after a second conservative surgery.
Exclusion Criteria:
Intraoperative radiotherapy with any device after conservative surgery in early breast cancer
Characteristics of patients treated with intraoperative radiotherapy according to the conditions of standard clinical practice,
To evaluate the characteristics of patients treated with intraoperative radiotherapy according to the conditions of standard clinical practice, retrospectively from the beginning of the implementation of the technique and prospectively from the launch of this registry.
Time frame: From enrollement to the end of recruitment at 10 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Parc de Salut Mar