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Towards a minimally invasive approach of atypical lipomatous tumors: the MINIMALIST trial

Recruiting
Conditions
-Atypical lipomatous tumor-Well-differentiatied liposarcoma-Lipoma
Registration Number
NL-OMON27031
Lead Sponsor
Erasmus MC Cancer Institute
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
238
Inclusion Criteria

Aged =18 years
-Primary or recurrent lipomatous tumor suspected for lipoma or atypical lipomatous tumor
-Adequate understanding of the Dutch or English language (to fill out the HRQoL questionnaires)

Exclusion Criteria

-Tumor localization in the mediastinum, retroperitoneum or testis/scrotum
-Diagnosis through excisional biopsy
-Any type of treatment for the current tumor (i.e. in case of recurrence, treatment of the prior tumor(s) is allowed)
-Signs/suspicion of dedifferentiation in the biopsy specimen at time of diagnosis
-Unable to undergo regular MRI-scans (for example because of a pacemaker, claustrophobia)
-Systemic treatment for any other concurrent malignancy
-Currently receiving radiotherapy at affected site for other concurrent disease
-Incapable to understand the study, to sign informed consent or to fill out the HRQoL-questionnaires

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The main study endpoint is the choice of treatment (i.e. AS or surgery) to determine the feasibility of AS and the occurrence of dedifferentiation to determine the safety. Dedifferentiation has to be pathologically proven upon biopsy or resection.
Secondary Outcome Measures
NameTimeMethod
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