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Official Title

REtroperitoneal SArcoma Registry (RESAR): Prospective Collection of Primary Retroperitoneal Sarcoma Patient's Data, Radiological and Pathological Material for the TransAtlantic Retroperitoneal Sarcoma Working Group

Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Enrollment
2,000
Timeline
Sep 2016 → Dec 2030
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1primary RPS operated on in the participating center;
  • 2age\>18 years at the time of the first treatment (pediatric patients can not be included)
  • 3histological confirmed diagnosis according to the WHO criteria done on biopsy or surgical specimen by dedicated sarcoma pathologist;
  • 4radiological examinations performed (contrast enhanced abdominal CT scan and/or MRI) prior to surgical resection;
  • 5signed informed consent form;
  • 6adequate compliance of the patients to the plan of follow-up

Exclusion Criteria

  • 1age\<18 years;
  • 2recurrent tumor;
  • 3benign retroperitoneal tumors;
  • 4serious psychiatric disease that precludes informed consent or limits compliance;
  • 5impossibility to ensure adequate follow-up

Locations

22 sites participating in this study

Winship Cancer Institute

Emory, Georgia 30322

Recruiting

Kenneth Cardona, MD

University of Southern California (USC)

Los Angeles, California 90033

Recruiting

William Tseng, MD

Mayo Clinic

Jacksonville, Florida 32224

Recruiting

Sanjay Bagaria, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →