RECRUITING

REtroperitoneal SArcoma Registry: an International Prospective Initiative

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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.

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

Quick Facts

Study Start:2016-09-01
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03838718

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * primary RPS operated on in the participating center;
  2. * age\>18 years at the time of the first treatment (pediatric patients can not be included)
  3. * histological confirmed diagnosis according to the WHO criteria done on biopsy or surgical specimen by dedicated sarcoma pathologist;
  4. * radiological examinations performed (contrast enhanced abdominal CT scan and/or MRI) prior to surgical resection;
  5. * signed informed consent form;
  6. * adequate compliance of the patients to the plan of follow-up
  1. * age\<18 years;
  2. * recurrent tumor;
  3. * benign retroperitoneal tumors;
  4. * serious psychiatric disease that precludes informed consent or limits compliance;
  5. * impossibility to ensure adequate follow-up

Contacts and Locations

Study Contact

Alessandro Gronchi, MD
CONTACT
+39022390
alessandro.gronchi@istitutotumori.mi.it
Marco Fiore, MD
CONTACT
+392390
marco.fiore@istitutotumori.mi.it

Principal Investigator

Alessandro Gronchi, MD
PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Marco Fiore, MD
STUDY_DIRECTOR
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Locations (Sites)

University of Southern California (USC)
Los Angeles, California, 90033
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Winship Cancer Institute
Emory, Georgia, 30322
United States
Brigham and Women's Hospital/Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
The Ohio State University
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  • Alessandro Gronchi, MD, PRINCIPAL_INVESTIGATOR, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
  • Marco Fiore, MD, STUDY_DIRECTOR, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-09-01
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2016-09-01
Study Completion Date2030-12-31

Terms related to this study

Keywords Provided by Researchers

  • Sarcoma
  • Surgery
  • Multivisceral resection
  • Chemotherapy
  • Radiation Therapy
  • Patients' Registry

Additional Relevant MeSH Terms

  • Retroperitoneal Sarcoma