Collects data and samples from people with retroperitoneal sarcoma treated with surgery
Records information and tumor samples from adults with retroperitoneal sarcoma who have surgery.
Plain-language title generated from the registry record
Registry title: REtroperitoneal SArcoma Registry: an International Prospective Initiative
Key facts
- Where
- Milan, Padova, and Verona, ItalySee the 3 sites
Where in Italy
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyTaking people
- Veneto Institute of OncologyPadova, ItalyTaking people
- Ospedale Borgo RomaVerona, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Trial code
- NCT03838718
- Record updated
- 12 February 2019
- Original description
Surgery is currently the only potentially curative treatment modality for localized retroperitoneal sarcoma (RPS). Available studies regarding oncologic outcomes are mainly retrospective in nature, and RPS are recognized as a rare disease. Therefore, prospective analysis of high quality data is a top priority.Read full original descriptionShow less
REtroperitoneal SArcoma Registry (RESAR): Prospective Collection of Primary Retroperitoneal Sarcoma Patient's Data, Radiological and Pathological Material for the TransAtlantic Retroperitoneal Sarcoma Working Group
Surgery is currently the only potentially curative treatment modality for localized retroperitoneal sarcoma (RPS). Available studies regarding oncologic outcomes are mainly retrospective in nature, and RPS are recognized as a rare disease. Therefore, prospective analysis of high quality data is a top priority.
Primary Objectives of this study are:
* to prospectively collect standardized clinical data and radiological and pathological material from primary RPS patients treated with surgery at reference centers. * patient outcome will be evaluated in terms of overall survival (OS), disease-free survival (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM).
Secondary Objectives:
* to estimate the efficacy and safety of surgical treatment, including extended surgical approach to primary RPS; * to prospectively evaluate the impact of multimodality therapy, including radiation therapy and chemotherapy; * to identify clinical, radiological and pathological characteristics that may influence the oncological outcome or may be used as predictors of LR/DM/OS. These may be important biomarkers of disease; * to utilize collected pathological material for research collaborations.
Inclusion: primary RPS operated on in the participating center; age>18 years at the time of the first treatment (pediatric patients can not be included); histological confirmed diagnosis according to the WHO criteria done on biopsy or surgical specimen by dedicated sarcoma pathologist; radiological examinations performed (contrast enhanced abdominal CT scan and/or MRI) prior to surgical resection; signed informed consent form; adequate compliance of the patients to the plan of follow-up.
Exclusion: serious psychiatric disease that precludes informed consent or limits compliance; age<18 years; recurrent tumor; benign retroperitoneal tumors; impossibility to ensure adequate follow-up.