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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03838718




Registration number
NCT03838718
Ethics application status
Date submitted
29/03/2018
Date registered
12/02/2019

Titles & IDs
Public title
REtroperitoneal SArcoma Registry: an International Prospective Initiative
Scientific 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
Secondary ID [1] 0 0
201/16
Universal Trial Number (UTN)
Trial acronym
RESAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retroperitoneal Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free Survival
Timepoint [1] 0 0
10 years
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
10 years
Secondary outcome [2] 0 0
Crude cumulative incidence of Local recurrence
Timepoint [2] 0 0
10 years
Secondary outcome [3] 0 0
Crude cumulative incidence of Distant metastasis
Timepoint [3] 0 0
10 years
Secondary outcome [4] 0 0
Morbidity
Timepoint [4] 0 0
60 days

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* age<18 years;
* recurrent tumor;
* benign retroperitoneal tumors;
* serious psychiatric disease that precludes informed consent or limits compliance;
* impossibility to ensure adequate follow-up

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Center - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
Canada
State/province [6] 0 0
Montréal
Country [7] 0 0
Canada
State/province [7] 0 0
Ottawa
Country [8] 0 0
Canada
State/province [8] 0 0
Toronto
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
Germany
State/province [10] 0 0
Mannheim
Country [11] 0 0
Germany
State/province [11] 0 0
Munich
Country [12] 0 0
Italy
State/province [12] 0 0
Milan
Country [13] 0 0
Italy
State/province [13] 0 0
Padova
Country [14] 0 0
Italy
State/province [14] 0 0
Verona
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Poland
State/province [16] 0 0
Warsaw
Country [17] 0 0
Slovenia
State/province [17] 0 0
Ljubljana
Country [18] 0 0
Spain
State/province [18] 0 0
Murcia
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Birmingham
Country [20] 0 0
United Kingdom
State/province [20] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
TransAtlantic Retroperitoneal Sarcoma Working Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alessandro Gronchi, MD
Address 0 0
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alessandro Gronchi, MD
Address 0 0
Country 0 0
Phone 0 0
+39022390
Fax 0 0
Email 0 0
alessandro.gronchi@istitutotumori.mi.it
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03838718