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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27031

Enrollment

238

Registered

2020-06-24

Start date

2020-06-24

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

None listed

Interventions

Active surveillance

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- Tumor growth/progression: To evaluate progression/tumor growth, the diameter of the tumor will be measured in three dimensions. Progression is defined as having twice progressive disease on two consecutive MRI-scans. Progressive disease (PD) is defined as an increase of =20% in the sum of diameters compared to the sum of diameters of the prior MRI documented during the study period, in accordance with the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). - Motives for treatment decision making and switching: Patients will be asked why they have chosen one of the two treatment modalities, or why they want to switch from active surveillance to surgery (if applicable). - Validation of the radiomics model: For the evaluation of the radiomics model, we will use the area under the ROC curve (AUC), accuracy, sensitivity, specificity, negative predictive value and positive predictive value. - Health-related Quality of Life: To evaluate the prevalence and changes in HRQoL a baseline questionnaire and 5 different HRQoL questionnaires will be used: the General Self Efficacy (GSE) questionnaire (Dutch version 1994), the EORTC-QLQ C30 (version 3), the HADS (Dutch version 1997) the TESS (Dutch version 2017) and the Decision Regret Scale (Dutch version 2010). - Biobank: Biobank consisting of biopsies and (if applicable) resection specimens for future translational research.	—

Measure

Time frame

- Tumor growth/progression: To evaluate progression/tumor growth, the diameter of the tumor will be measured in three dimensions. Progression is defined as having twice progressive disease on two consecutive MRI-scans. Progressive disease (PD) is defined as an increase of =20% in the sum of diameters compared to the sum of diameters of the prior MRI documented during the study period, in accordance with the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). - Motives for treatment decision making and switching: Patients will be asked why they have chosen one of the two treatment modalities, or why they want to switch from active surveillance to surgery (if applicable). - Validation of the radiomics model: For the evaluation of the radiomics model, we will use the area under the ROC curve (AUC), accuracy, sensitivity, specificity, negative predictive value and positive predictive value. - Health-related Quality of Life: To evaluate the prevalence and changes in HRQoL a baseline questionnaire and 5 different HRQoL questionnaires will be used: the General Self Efficacy (GSE) questionnaire (Dutch version 1994), the EORTC-QLQ C30 (version 3), the HADS (Dutch version 1997) the TESS (Dutch version 2017) and the Decision Regret Scale (Dutch version 2010). - Biobank: Biobank consisting of biopsies and (if applicable) resection specimens for future translational research.

—

Contacts

Public ContactAnne-Rose Schut

Erasmus MC

minimalist@erasmusmc.nl010 704 12 23

Outcome results