Hospital del Mar
Barcelona, 08003, Spain
NCT Number: NCT07030231
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Barcelona, 08003, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intraoperative radiotherapy with any device after conservative surgery in early breast cancer
Time frame: From enrollement to the end of recruitment at 10 years
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.
Parc de Salut Mar
Other
Utilización de la Radioterapia IntraOperatoria en la Neoplasia de MAma
Acronym: RIOMA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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