## Protocol Section
### Identification Module
**NCT ID:** NCT06432660

**Acronym:** PROMPT

**Brief Title:** Prospective Registry of Ocular Melanoma Eye Plaque brachyTherapy Patients

**Official Title:** Prospective Registry of Ocular Melanoma Eye Plaque brachyTherapy Patients (PROMPT)

#### Organization Study ID Info
**ID:** Pro00115893
#### Organization
**Class:** OTHER
**Full Name:** Duke University
### Status Module
#### Completion Date
**Date:** 2029-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2029-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Duke University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This prospective registry study will evaluate doses utilized in eye plaque brachytherapy for the treatment of ocular melanoma and their associated outcomes. The goal of this study is to evaluate if lower doses of radiation can maintain high local control rates while minimizing the toxicities related to radiation therapy.

### Conditions Module

**Conditions:**

- Ocular Melanoma

**Keywords:**

- eye plaque brachytherapy

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 5 Years

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients 18 years of age or older with unilateral primary choroidal melanoma

**Intervention Names:**

- Other: Data collection

**Label:** Ocular Melanoma

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Ocular Melanoma

**Description:** Information about radiation therapy via eye plaque brachytherapy and follow up

**Name:** Data collection

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Number of disease free participants expressed as a percentage of the total number of participants enrolled

**Measure:** Percentage of participants with no disease recurrence within the radiation therapy field.

**Time Frame:** 5 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients 18 years of age or older with unilateral primary choroidal melanoma
* Patients with diagnosis of small or medium ocular melanomas amenable to plaque brachytherapy (as determined by treating ocular oncologist). Typically this would include tumors with apical height ≤10mm and basal diameter ≤16mm (small and medium tumors per COMS (Collaborative Ocular Melanoma Study)
* Patients with no clinical evidence of metastatic disease as confirmed by negative staging imaging (CT, MRI, and/or ultrasound)
* Patients with best-corrected visual acuity in the fellow eye of 20/200 or better
* Patients must be treated with IsoAid Eye Physics eye plaques

Exclusion Criteria:

* Patients whose tumors are circumferential around the optic disc and cannot be adequately covered by the prescription dose are ineligible.
* Similarly, patients with extrascleral tumor extension detected during echography or clinical exam, diffuse, ring or multifocal tumors that cannot be encompassed in a single episcleral plaque or tumors judged to be predominantly ciliary body or iris melanoma will be considered ineligible
* Previous treatment for ocular melanoma in either eye or treatment of any condition secondary to the tumor are ineligible.
* Patients with a history of other primary or metastatic cancers are not eligible, except for non-melanotic skin cancers
* Patients with extraocular disease

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** The study population will include adult patients seen at the Duke Eye Center and/or Duke Department of Radiation Oncology who meet the eligibility criteria.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Joan.Cahill@duke.edu

**Name:** Joan Cahill, BNS RN OCN

**Phone:** (919) 668-5211

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Duke University Health System (DUHS)

**Name:** Dianda Ayala-Peacock, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Meltsner SG, Rodrigues A, Materin MA, Kirsch DG, Craciunescu O. Transitioning from a COMS-based plaque brachytherapy program to using eye physics plaques and plaque simulator treatment planning system: A single institutional experience. J Appl Clin Med Phys. 2023 May;24(5):e13902. doi: 10.1002/acm2.13902. Epub 2023 Jan 13.

**PMID:** 36637797

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000018358

- Term: Neuroendocrine Tumors

- ID: D000017599

- Term: Neuroectodermal Tumors

- ID: D000009373

- Term: Neoplasms, Germ Cell and Embryonal

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000009380

- Term: Neoplasms, Nerve Tissue

- ID: D000018326

- Term: Nevi and Melanomas

- ID: D000012878

- Term: Skin Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11528

- Name: Melanoma

- Relevance: HIGH

- As Found: Melanoma

- ID: M20495

- Name: Neuroendocrine Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M19845

- Name: Neuroectodermal Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M20388

- Name: Neuroectodermal Tumors, Primitive

- Relevance: LOW

- As Found: Unknown

- ID: M12318

- Name: Neoplasms, Germ Cell and Embryonal

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M12325

- Name: Neoplasms, Nerve Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M12448

- Name: Nevus, Pigmented

- Relevance: LOW

- As Found: Unknown

- ID: M12446

- Name: Nevus

- Relevance: LOW

- As Found: Unknown

- ID: M20470

- Name: Nevi and Melanomas

- Relevance: LOW

- As Found: Unknown

- ID: M15681

- Name: Skin Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4192

- Name: Ocular Melanoma

- Relevance: HIGH

- As Found: Ocular Melanoma

- ID: T4091

- Name: Neuroendocrine Tumor

- Relevance: LOW

- As Found: Unknown

- ID: T4092

- Name: Neuroepithelioma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008545

- Term: Melanoma

### Misc Info Module

- Version Holder: 2024-05-31
