NCT03838718Recruiting
REtroperitoneal SArcoma Registry: an International Prospective Initiative
REtroperitoneal SArcoma Registry (RESAR): Prospective Collection of Primary Retroperitoneal Sarcoma Patient's Data, Radiological and Pathological Material for the TransAtlantic Retroperitoneal Sarcoma Working Group
Source: ClinicalTrials.gov · Last updated 12 Feb 2019 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 29 Mar 2018
- Start date
- 1 Sept 2016
- Primary completion date
- 31 Dec 2020
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Diseases
- Sarcoma
- NCT number
- NCT03838718
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 1 Sept 2016 to the primary completion date, 31 Dec 2020
- 22 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- serious psychiatric disease that precludes informed consent or limits compliance;
Age
- age\<18 years;
Other
- recurrent tumor;
- benign retroperitoneal tumors;
- impossibility to ensure adequate follow-up
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peter MacCallum Cancer Center Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Maisonneuve-Rosemont Hospital / University of Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| The Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Mount Sinai / Princess Margaret Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| University Medical Center and Medical Faculty Mannheim, University of Heidelberg Coordinator of this site? Confirm its status | Mannheim | Germany | Not yet recruiting |
| Ludwig Maximilian University Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Hospital Clínico Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Not yet recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| University Hospital Birmingham (Queen Elizabeth) Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| Royal Marsden Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Veneto Institute of Oncology Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Ospedale Borgo Roma Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Institute of Oncology Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Recruiting |
| Brigham and Women's Hospital / Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Winship Cancer Institute Coordinator of this site? Confirm its status | Emory | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| University of Southern California (USC) Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.