An observational study in Uveal Melanoma, sponsored by Leiden University Medical Center. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Leiden University Medical Center · Observational
PROQEM is a prospective cohort study among patients diagnosed with uveal melanoma to assess quality of life before and in the first five years after treatment.
PROQEM is a prospective observational cohort study wherein patients with uveal melanoma are registered at diagnosis and are requested to fill in an array of questionaires before treatment and at 3, 6, 12, 24, 36 and 60 months after treatment. A comprehensive overview of the impact of their disease and treatment on quality of life is obtained by systematic assessment of the psychological impact of the initial diagnosis, eye symptoms, physical, emotional, social and role functioning.
In addition, the PROQEM has a substudy called the PROQEM-pco (Preferences, Choices and Outcomes) for the subgroup of patients who are eligible for both proton therapy and enucleation. They are invited to participate in research on patient preferences and shared decision-making. The consultations wherein the treatment decision is made are audiotaped and data on perceived shared decision-making, preferences, decision satisfaction and -regret are collected by questionaires at baseline and in the first 36 months after treatment.
103 studies on the registry are indexed under Uveal Melanoma; 38 are open to participants now.
This study's planned enrollment of 500 is above the median of 100 across 10 observational studies indexed under Uveal Melanoma.
Browse Uveal Melanoma studies →Leiden University Medical Center is the lead sponsor of 326 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with uveal melanoma who will be treated with brachytherapy, proton therapy or enucleation with curative intent
Exclusion Criteria:
Uveal melanoma patients treated with Ruthenium-106 plaque brachytherapy
Other: Quality of life questionnaires
Uveal melanoma patients treated with proton therapy
Other: Quality of life questionnaires · Other: Discrete choice experiment · Other: Shared decision-making analysis · Other: Impact of side-effects analysis
Uveal melanoma patients treated with enucleation
Other: Quality of life questionnaires · Other: Discrete choice experiment · Other: Shared decision-making analysis · Other: Impact of side-effects analysis
Collection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis
Also known as: EORTC-QLQ-C30, EORTC-QLQ-OPT30, EQ-5D-5L, Impact of events scale
Assessment of patient preferences for outcomes of proton therapy and enucleation
Also known as: DCE
Assessment of shared decision-making from the perspective of the patient (by questionnaire), physician (by questionnaire) and a neutral observer (by audiotape), combined with patient-reported satisfaction and regret of the treatment decision (by questionnaire)
Also known as: Audiotape, iSHARE, Satisfaction with decision scale, Decision regret scale
Assessment of the impact of side-effects by questionnaire
Uveal melanoma-related quality of life
EORTC QLQ-OPT30
Time frame: 5 years
Health-related quality of life
EORTC QLQ-C30
Time frame: 5 years
General quality of life
EQ-5D-5L
Time frame: 5 years
Impact of the diagnosis and treatment of uveal melanoma on mental health
Impact of events scale
Time frame: 2 years
Patient preferences for outcomes of proton therapy and enucleation
Discrete choice experiment
Time frame: Cross-sectional at baseline
Shared decision-making
Audiotape, iSHARE, satisfaction with decision scale, decision regret scale
Time frame: 1 year
Impact of side-effects of treatment for uveal melanoma
Questionnaire specifically developed for uveal melanoma
Time frame: 3 years
Plan to share: Yes — The PROQEM study adheres to the FAIR principles of data stewardship. Due to privacy regulations the data of the PROQEM study will not be made publicly accessible, but can be made available upon request.
Supporting information: Study protocol, Sap, Analytic code
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Leiden University Medical Center