Uveal MelanomaPRIMENCT07913412
High-precision Radiosurgery Followed by Minimally Invasive Surgical Approach in Patients With High-prominence Uveal Melanoma: Modern Radiation Techniques and Outcomes
An observational study of Uveal Melanoma and High-risk Uveal Melanoma, run by University Hospital, Essen at 3 sites in Germany.
Trial summary
High-precision radiosurgery followed by minimally invasive surgical approach in patients with high-prominence uveal melanomas: modern radiation techniques and outcomes. Evaluation of outcome regarding multiparametric parameters and co-factors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma, High-risk Uveal Melanoma, Prominent Uveal Melanoma
- How many people
- 250 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Sep 2019to 30 Jun 2032
- How long will I take part?
- 5 Years
- 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: Inclusion Criteria: - Resectability, high-prominent and high risk uveal melanoma Exclusion Criteria: * EOE * lux defect (If a medical report notes a "lux defect" alongside this, it refers to a deficit in light perception (from the Latin lux for light). It means the eye's ability to sense light, darkness, or light direction is impaired)
Who may be able to join
- Functional Resectability,
- Technical Resectability
- high-prominent uveal melanoma
Who cannot join
- EOE
- At least in part remaining eye function that can be saved
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West
Essen, Germany / NRW, 45147
Maja Guberina, PD Dr. med. (MD), specialist, +492017232321, maja.guberina@uk-essen.de
Ina Grübel
- Recruiting
Maja Guberina
Essen, 45147
Maja W Strahlentherapie, +492017232321, maja.guberina@uk-essen.de
- Recruiting
University Hospital Essen
Essen
Maja Guberina, +4920127232321, maja.guberina@uk-essen.de
About this study
Official title: High-precision Radiosurgery Followed by Minimally Invasive Surgical Approach in Patients With High-prominence Uveal Melanoma: Modern Radiation Techniques and Outcomes; PRIME: P: Precision R: Radiosurgery I: Intervention M: Minimal Invasive Surgical Approach E: EYESIGHT
High-precision radiosurgery followed by minimally invasive surgical approach in patients with high-prominence uveal melanomas: modern radiation techniques and outcomes. Evaluation of outcome regarding multiparametric parameters and co-factors
Read the detailed description
The aim here is to prospectively evaluate modern technical standards. The aim of this study is to assess the influence of the updated basic diagnostics and high-resolution diagnostics for radiation planning and the new technical therapy standards (therapy options in application: volume modulated rapid arc technique (VMAT) / online arc technique (VMAT) / online onboard image-guidance (IGRT), by means of the newly established Clinic for Radiation Therapy 2019-2021) depending on known prognostic parameters for quality assurance of the long-term outcome (overall survival, local tumor control). This will lay the basis for standardizing treatment parameters as far as possible, but also to introduce improvements in the treatment of future patients.
Scientific background (state of research (with literature references) and
Derivation of the research question (rationale)):
The eye can be affected by several neoplastic processes, which can lead either primarily or secondary to systemic metastasis. The most common primary tumors of the eye include conjunctival melanoma and uveal melanoma. Metastases from systemic malignant diseases, particularly of the breast and lungs, can also affect the eye.
A combination of ophthalmologic examination, MRI and additional tests and cytologic/histopathologic evaluation leads to an accurate diagnosis.
Depending on the tumor manifestation, treatment consists of a multimodal concept. In the case of uveal melanomas and the aim of preserving the globe and and visual acuity preservation, radiotherapy is one of the most important treatment modalities that can be applied.
In the last 20 years, radiotherapy has developed rapidly away from two-dimensional modulated, three-dimensional techniques. But here too the high level of technical diversity in radiotherapy and ever newer technical innovations, there is a broad spectrum of radiotherapy. Standard therapy can be performed using modern devices, the high-precision stereotactic linear accelerators (irradiation devices), can be safely further optimized. This is to be tested in the Department of Radiotherapy.
- Keywords
- radiotherapy, radiosurgery, minimal invasive, surgery and resection, vision, eyesight
- Medical subject headings
- Uveal Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control
Local control
Measured: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Function: Visual acuity:
Visual function assessed separately for each eye. Visual acuity:
decimal scale,range 2,0 - 0,01: decimal acuity scale
Measured: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Quality of Life, ophthalmic cancer-specific quality of life
Quality of Life, ophthalmic cancer-specific quality of life
- EORTC QLQ-OPT30 (ophthalmic cancer-specific quality of life): Scores range from 0-100; higher scores indicate greater visual impairment, ocular symptoms, and functional difficulties.
Measured: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Progression Free Survival
Progression Free Survival
Measured: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Overall Survival
Overall Survival
Measured: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Function: Visual acuity:
Visual function assessed separately for each eye. Visual acuity:
decimal scale,range 2,0 - 0,01: decimal acuity scale; furthermore, 1.Count-fingers, 2.hand-motion and 3.light-perception categories are recorded separately when acuity cannot be quantified: for each item: value yes / no
Measured: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Function: Visual field
Visual field: Automated perimetry, Visual Field Index (VFI, %): 0 % - 100%,
Measured: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Quality of Life general quality of life
EORTC QLQ-C30 (general quality of life): Scores range from 0-100; A) higher scores indicate better functioning/global quality of life B) symptom scores: indicate greater symptom burden on symptom scales.
Measured: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Function: Retinal Nerve Fiber Layer
Optical coherence tomography (OCT): Peripapillary retinal nerve fiber layer (RNFL) thickness, measured in µm and classified in percentiles (regarding normal values)
Measured: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Cornea
corneal outcome: thickness measured in µm
Measured: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Cornea
Corneal outcome modified Stocker's classification:
category 0 No damage no injury category 1 corneal guttae without epithelial or stromal edema. category 2 corneal guttae with epithelial or stromal edema. category 3 corneal edema associated with scar formation. category 4 corneal opacification with neovascularization, modified Stocker's classification
Measured: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Corneal overall outcome classification
category 0 No corneal-ulcus category 1 Irregular punctate epithelial defects category 2 Non-healing epithelial defects / persistent epithelial defect (PED) category 3 Ulcer perforation
Measured: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Sep 2019
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- 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
- 250 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maja Guberina, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913412
- Sponsor's protocol ID
- 21-10377-BO
- Acronym
- PRIME
- Status last verified
- Nov 2026
- First submitted
- 18 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: dependent on the project
Publications
Guberina M, Sokolenko E, Guberina N, Dalbah S, Pottgen C, Lubcke W, Indenkampen F, Lachmuth M, Fluhs D, Chen Y, Hoffmann C, Deuschl C, Jabbarli L, Fiorentzis M, Foerster A, Rating P, Ebenau M, Grunewald T, Bechrakis N, Stuschke M. Feasibility, Method and Early Outcome of Image-Guided Volumetric Modulated Arc Radiosurgery Followed by Resection for AJCC Stage IIA-IIIB High-Risk Large Intraocular Melanoma. Cancers (Basel). 2022 Sep 28;14(19):4729. doi: 10.3390/cancers14194729.
PubMed 36230660
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-precision Radiosurgery Followed by Minimally Invasive Surgical Approach in Patients With High-prominence Uveal Melanoma: Modern Radiation Techniques and Outcomes; PRIME: P: Precision R: Radiosurgery I: Intervention M: Minimal Invasive Surgical Approach E: EYESIGHT
- ClinicalTrials.gov ID
- NCT07913412
- Acronym / sponsor ID
- PRIME / 21-10377-BO
- Keywords
- radiotherapy, radiosurgery, minimal invasive, surgery and resection, vision, eyesight
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 3 Nov 2026 (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.
High-precision radiosurgery followed by minimally invasive surgical approach in patients with high-prominence uveal melanomas: modern radiation techniques and outcomes. Evaluation of outcome regarding multiparametric parameters and co-factors
Detailed description
The aim here is to prospectively evaluate modern technical standards. The aim of this study is to assess the influence of the updated basic diagnostics and high-resolution diagnostics for radiation planning and the new technical therapy standards (therapy options in application: volume modulated rapid arc technique (VMAT) / online arc technique (VMAT) / online onboard image-guidance (IGRT), by means of the newly established Clinic for Radiation Therapy 2019-2021) depending on known prognostic parameters for quality assurance of the long-term outcome (overall survival, local tumor control). This will lay the basis for standardizing treatment parameters as far as possible, but also to introduce improvements in the treatment of future patients.
Scientific background (state of research (with literature references) and
Derivation of the research question (rationale)):
The eye can be affected by several neoplastic processes, which can lead either primarily or secondary to systemic metastasis. The most common primary tumors of the eye include conjunctival melanoma and uveal melanoma. Metastases from systemic malignant diseases, particularly of the breast and lungs, can also affect the eye.
A combination of ophthalmologic examination, MRI and additional tests and cytologic/histopathologic evaluation leads to an accurate diagnosis.
Depending on the tumor manifestation, treatment consists of a multimodal concept. In the case of uveal melanomas and the aim of preserving the globe and and visual acuity preservation, radiotherapy is one of the most important treatment modalities that can be applied.
In the last 20 years, radiotherapy has developed rapidly away from two-dimensional modulated, three-dimensional techniques. But here too the high level of technical diversity in radiotherapy and ever newer technical innovations, there is a broad spectrum of radiotherapy. Standard therapy can be performed using modern devices, the high-precision stereotactic linear accelerators (irradiation devices), can be safely further optimized. This is to be tested in the Department of Radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria: - Resectability, high-prominent and high risk uveal melanoma Exclusion Criteria: * EOE * lux defect (If a medical report notes a "lux defect" alongside this, it refers to a deficit in light perception (from the Latin lux for light). It means the eye's ability to sense light, darkness, or light direction is impaired)
Key inclusion criteria (3 listed)
- Functional Resectability,
- Technical Resectability
- high-prominent uveal melanoma
Key exclusion criteria (2 listed)
- EOE
- At least in part remaining eye function that can be saved
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Local control
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Local control
Function: Visual acuity:
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Visual function assessed separately for each eye. Visual acuity: decimal scale,range 2,0 - 0,01: decimal acuity scale
Quality of Life, ophthalmic cancer-specific quality of life
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Quality of Life, ophthalmic cancer-specific quality of life 1) EORTC QLQ-OPT30 (ophthalmic cancer-specific quality of life): Scores range from 0-100; higher scores indicate greater visual impairment, ocular symptoms, and functional difficulties.
Progression Free Survival
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Progression Free Survival
Overall Survival
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Overall Survival
Function: Visual acuity:
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Visual function assessed separately for each eye. Visual acuity: decimal scale,range 2,0 - 0,01: decimal acuity scale; furthermore, 1.Count-fingers, 2.hand-motion and 3.light-perception categories are recorded separately when acuity cannot be quantified: for each item: value yes / no
Function: Visual field
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Visual field: Automated perimetry, Visual Field Index (VFI, %): 0 % - 100%,
Quality of Life general quality of life
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
EORTC QLQ-C30 (general quality of life): Scores range from 0-100; A) higher scores indicate better functioning/global quality of life B) symptom scores: indicate greater symptom burden on symptom scales.
Function: Retinal Nerve Fiber Layer
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Optical coherence tomography (OCT): Peripapillary retinal nerve fiber layer (RNFL) thickness, measured in µm and classified in percentiles (regarding normal values)
Cornea
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
corneal outcome: thickness measured in µm
Cornea
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Corneal outcome modified Stocker's classification: category 0 No damage no injury category 1 corneal guttae without epithelial or stromal edema. category 2 corneal guttae with epithelial or stromal edema. category 3 corneal edema associated with scar formation. category 4 corneal opacification with neovascularization, modified Stocker's classification
Corneal overall outcome classification
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
category 0 No corneal-ulcus category 1 Irregular punctate epithelial defects category 2 Non-healing epithelial defects / persistent epithelial defect (PED) category 3 Ulcer perforation
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 3 Nov 2026.
- Background: PubMed 36230660Guberina M, Sokolenko E, Guberina N, Dalbah S, Pottgen C, Lubcke W, Indenkampen F, Lachmuth M, Fluhs D, Chen Y, Hoffmann C, Deuschl C, Jabbarli L, Fiorentzis M, Foerster A, Rating P, Ebenau M, Grunewald T, Bechrakis N, Stuschke M. Feasibility, Method and Early Outcome of Image-Guided Volumetric Modulated Arc Radiosurgery Followed by Resection for AJCC Stage IIA-IIIB High-Risk Large Intraocular Melanoma. Cancers (Basel). 2022 Sep 28;14(19):4729. doi: 10.3390/cancers14194729.
- Individual participant dataSharing planned: Undecided. dependent on the project
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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.
3 sites 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 and High-risk Uveal Melanoma, run by University Hospital, Essen at 3 sites in Germany.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
Contact Maja Guberina, PD MD (0201 723 83121, maja.guberina@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control (time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07913412, which also lists 1 linked publication.
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 3 Nov 2026.