Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- None

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05377957
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Leiden University Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Nanda Horeweg, Md PhD
Principal Investigator Affiliation	Leiden University Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Uveal Melanoma

Additional Details

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.

Arms & Interventions

Arms

: Brachytherapy

Uveal melanoma patients treated with Ruthenium-106 plaque brachytherapy

: Proton therapy

Uveal melanoma patients treated with proton therapy

: Enucleation

Uveal melanoma patients treated with enucleation

Interventions

Other: - Quality of life questionnaires

Collection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis

Other: - Discrete choice experiment

Assessment of patient preferences for outcomes of proton therapy and enucleation

Other: - Shared decision-making analysis

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)

Other: - Impact of side-effects analysis

Assessment of the impact of side-effects by questionnaire

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Leiden University Medical Center, Leiden, Zuid-Holland, Netherlands

Status

Recruiting

Address

Leiden University Medical Center

Leiden, Zuid-Holland, 2333ZA

Site Contact

Nanda Horeweg, MD PhD

[email protected]

+31725165539

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