Uveal MelanomaPROQEMNCT05377957
Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients
An observational study of Uveal Melanoma, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- Quality of life questionnaires, Discrete choice experiment and Shared decision-making analysis
- How many people
- 500 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Mar 2019to 1 Apr 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with uveal melanoma who will be treated with brachytherapy, proton therapy or enucleation with curative intent
Who may be able to join
- Age ≥18 years
- Clinical or pathological diagnosis of a melanoma of the choroid or ciliary body
- No signs of metastasis after staging procedures with at least an X-thorax, blood test and an ultrasound of the liver
- Treatment by brachytherapy, proton therapy or enucleation
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333ZA
About this study
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.
Read the detailed description
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.
- Conditions
- Uveal Melanoma
- Being tested
- Quality of life questionnaires, Discrete choice experiment, Shared decision-making analysis, Impact of side-effects analysis
- Keywords
- Uveal Melanoma, Quality of Life, Shared decision-making, Patient preferences, Brachytherapy, Proton therapy, Enucleation
- Medical subject headings
- Uveal Melanoma, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnairesOther
Also called EORTC-QLQ-C30, EORTC-QLQ-OPT30, EQ-5D-5L, Impact of events scale
Collection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis
Discrete choice experimentOther
Also called DCE
Assessment of patient preferences for outcomes of proton therapy and enucleation
Shared decision-making analysisOther
Also called Audiotape, iSHARE, Satisfaction with decision scale, Decision regret scale
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)
Impact of side-effects analysisOther
Assessment of the impact of side-effects by questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Brachytherapy | Uveal melanoma patients treated with Ruthenium-106 plaque brachytherapy Receives: Other: Quality of life questionnaires | |
| Proton therapy | Uveal melanoma patients treated with proton therapy Receives: Other: Quality of life questionnaires; Other: Discrete choice experiment; Other: Shared decision-making analysis; Other: Impact of side-effects analysis | |
| Enucleation | Uveal melanoma patients treated with enucleation Receives: Other: Quality of life questionnaires; Other: Discrete choice experiment; Other: Shared decision-making analysis; Other: Impact of side-effects analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uveal melanoma-related quality of life
EORTC QLQ-OPT30
Measured: 5 years
Health-related quality of life
EORTC QLQ-C30
Measured: 5 years
General quality of life
EQ-5D-5L
Measured: 5 years
Impact of the diagnosis and treatment of uveal melanoma on mental health
Impact of events scale
Measured: 2 years
Secondary outcomes (3)
Patient preferences for outcomes of proton therapy and enucleation
Discrete choice experiment
Measured: Cross-sectional at baseline
Shared decision-making
Audiotape, iSHARE, satisfaction with decision scale, decision regret scale
Measured: 1 year
Impact of side-effects of treatment for uveal melanoma
Questionnaire specifically developed for uveal melanoma
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start5 Mar 2019
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nanda Horeweg, Leiden University Medical Center
- Investigators
- Nanda Horeweg, Md PhD, Study chair, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377957
- Sponsor's protocol ID
- PROQEM
- Acronym
- PROQEM
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2022
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients
- ClinicalTrials.gov ID
- NCT05377957
- Acronym / sponsor ID
- PROQEM / PROQEM
- Conditions
- Uveal Melanoma
- Keywords
- Uveal Melanoma, Quality of Life, Shared decision-making, Patient preferences, Brachytherapy, Proton therapy, Enucleation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brachytherapy | – | Other: Quality of life questionnairesUveal melanoma patients treated with Ruthenium-106 plaque brachytherapy |
| Proton therapy | – | Other: Quality of life questionnaires, Other: Discrete choice experiment, Other: Shared decision-making analysis, Other: Impact of side-effects analysisUveal melanoma patients treated with proton therapy |
| Enucleation | – | Other: Quality of life questionnaires, Other: Discrete choice experiment, Other: Shared decision-making analysis, Other: Impact of side-effects analysisUveal melanoma patients treated with enucleation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with uveal melanoma who will be treated with brachytherapy, proton therapy or enucleation with curative intent
Key inclusion criteria (4 listed)
- Age ≥18 years
- Clinical or pathological diagnosis of a melanoma of the choroid or ciliary body
- No signs of metastasis after staging procedures with at least an X-thorax, blood test and an ultrasound of the liver
- Treatment by brachytherapy, proton therapy or enucleation
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life questionnairesAlso: EORTC-QLQ-C30, EORTC-QLQ-OPT30, EQ-5D-5L, Impact of events scaleCollection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis | Other | Brachytherapy, Enucleation, Proton therapy |
| Discrete choice experimentAlso: DCEAssessment of patient preferences for outcomes of proton therapy and enucleation | Other | Enucleation, Proton therapy |
| Shared decision-making analysisAlso: Audiotape, iSHARE, Satisfaction with decision scale, Decision regret scaleAssessment 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) | Other | Enucleation, Proton therapy |
| Impact of side-effects analysisAssessment of the impact of side-effects by questionnaire | Other | Enucleation, Proton therapy |
Primary outcome
Uveal melanoma-related quality of life
Time frame: 5 years
EORTC QLQ-OPT30
Health-related quality of life
Time frame: 5 years
EORTC QLQ-C30
General quality of life
Time frame: 5 years
EQ-5D-5L
Impact of the diagnosis and treatment of uveal melanoma on mental health
Time frame: 2 years
Impact of events scale
3 secondary outcomes
Patient preferences for outcomes of proton therapy and enucleation
Time frame: Cross-sectional at baseline
Shared decision-making
Time frame: 1 year
Impact of side-effects of treatment for uveal melanoma
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nanda Horeweg, Md PhD study chair
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveal Melanoma, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uveal melanoma-related quality of life (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.