Tracking quality of life in patients with eye melanoma
Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients
This study is tracking how living with eye melanoma affects patients' quality of life over five years and looks at their preferences for treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden, Zuid-Holland) |
| Trial ID | NCT05377957 on ClinicalTrials.gov |
What this trial studies
PROQEM is a prospective observational cohort study that registers patients diagnosed with uveal melanoma at the time of diagnosis. Participants complete a series of questionnaires before treatment and at multiple intervals over five years to assess the impact of their disease and treatment on quality of life. The study also includes a substudy focusing on patient preferences and shared decision-making for those eligible for both proton therapy and enucleation, involving audiotaped consultations and follow-up questionnaires.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical or pathological diagnosis of uveal melanoma and no signs of metastasis.
Not a fit: Patients with metastatic uveal melanoma or those not receiving brachytherapy, proton therapy, or enucleation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the quality of life impacts of uveal melanoma treatments, guiding better patient care and decision-making.
How similar studies have performed: Other studies have successfully assessed quality of life in cancer patients, suggesting that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full 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
Where this trial is running
Leiden, Zuid-Holland
- Leiden University Medical Center — Leiden, Zuid-Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Nanda Horeweg, MD PhD
- Email: n.horeweg@lumc.nl
- Phone: +31725165539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.