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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54620
Enrollment
238
Registered
2020-06-19
Start date
2020-07-03
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atypical lipomatous tumor (lowgrade softtissue cancer) well differentiated liposarcoma

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Aged >=18 years - Primary or recurrent lipomatous tumor suspected for lipoma or well-differentiated liposarcoma - Adequate understanding of the Dutch or English language (to fill out the HRQoL questionnaires)

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - 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

Design outcomes

Primary

MeasureTime frame
The main study endpoints are choice of treatment (i.e. AS or surgery) to determine the feasibility of AS and the occurence of dedifferentiation to determine safety. AS will be considered feasible if at least 25% of the patients prefers AS over surgery, of whom at least 50% is still being treated with AS after one year of follow-up. AS will be considered safe if dedifferentiation occurs in

Secondary

MeasureTime frame
Secondary outcomes are evaluating tumor growth/progression, motives for treatment decision making and switching, validation of the radiomics model, to assess Health-related Quality of life and to develop a Biobank for future translational research.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)