Ignite Creation Date:
2024-07-17 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480396
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-24
Brief Title:
High Versus Lower Intensity Surveillance Following Resection of Retroperitoneal Sarcoma
Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Organization:
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Study Overview
Official Title:
An International Partially-randomised Patient-preference Trial Within a Registry of High Versus Lower Intensity Radiological Surveillance Following Primary Resection of Retroperitoneal Abdominal and Pelvic Soft Tissue Sarcoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SARveillance
Brief Summary:
The SARveillance trial is an efficient pragmatic multi-centre international stratified partially-randomised patient-preference trial within a registry of high versus lower intensity radiological surveillance following primary resection of retroperitoneal abdominal and pelvic soft tissue sarcoma The trial design is stratified by sarcoma tumour grade highintermediate grade and low grade
Detailed Description:
The SARveillance trial is an efficient pragmatic multi-centre international stratified partially-randomised patient-preference trial within a registry of high versus lower intensity radiological surveillance following primary resection of retroperitoneal abdominal and pelvic soft tissue sarcoma The trial design is stratified by sarcoma tumour grade highintermediate grade and low grade Both high and lower intensity follow-up represent current practice in different centres across the trial delivery network with variation at a centre and surgeon level SARveillance is co-produced in deep collaboration with a patient advisory group The delivery network is trans-continental including major sarcoma centres in Europe Asia and the Americas with central coordination from Istituto Nazionale Tumori Milan Italy and Birmingham Centre for Observational and Prospective Studies BiCOPS University of Birmingham UK For centres that would otherwise be precluded from participating in SARveillance due to institutional level data sharing restrictions provision has been made for prearranged Individual Participant Data Meta-Analysis IPDMA The IPDMA essentially replicates the instruments and processes of SARveillance at a single site level and allows for the PI to provide data for meta-analysis at the close of SARveillance rather than sharing real-time data with the SARveillance servers at the coordinating institutions Adult patients undergoing primary resection for retroperitoneal abdominal and pelvic sarcoma will be eligible for inclusion The trial design is innovative and efficient implemented as a trial within an international registry and adopting concepts from the pragmatic REaCT trial design methodology Patients that are willing to be randomised will be allocated in a 11 ratio to a high or lower intensity follow-up schedule For patients that decline randomisation the trial has patient preference arms to maximise insight into decision-making processes in the context of a rare disease and maximise participant recruitment The primary outcome measure is quality of life measured as emotional functioning EF up to 5 years after surgery measured 3-monthly using the questions relating to the EF domain of the European Organisation for Research and Treatment of Cancer EORTC Core Quality of Life questionnaire QLQ-C30 Secondary outcomes for the trial will be overall survival up to 5 years after surgery the cancer worry scale EORTC library health utility calculated using EuroQol Group EQ-5D-5L and cost-effectiveness health utility measured using EQ-5D-5L The primary outcome measure for low grade tumours is health utility Pre-planned sub-studies will be conducted including an economic analysis and validation study for a prognostic risk model
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None