Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT02602756
Eligibility Criteria:
Inclusion Criteria:
* Patient diagnosed with choroidal melanoma by an ophthalmologist and proton-therapy treatment proposed by the multi-disciplinary board meeting
* Patient over 18 years old, male or female
* Performance status ≤ 2
* Size and/or thickness greater than those proposed on proton-therapy appendix indications (tumor volume/ocular globe \> 40% and/or thickness ≥ 12 mm and/or diameter ≥ 18 mm or thickness ≥ 10 mm and diameter ≥ 15 mm). Possible ophthalmological follow-up examinations at 6 months, one year, 18 months and two years.
* No contraindication for adjuvant chemotherapy
* Authorized technique to preserve the optic nerve
* Patient having undergone the required medical procedures:
* Ophthalmological examination
* Clip positioning
* Proton-therapy treatment (localization CT, first simulation, second simulation, final simulation)
* Patient reads information note and signs consent form
Exclusion Criteria:
* Exclusive iris damage
* Exclusive conjunctival damage
* First melanoma surgery
* Enucleation planned post-proton-therapy
* Exentration indication
* Life expectancy \< 2 years
* Scleral exteriorisation \> 2 mm
* Absolute radiotherapy contraindication (ataxia-telangiectasia)
* Cancer history, except for complete remission cancers of over 5 years, basocellular skin carcinomas completely resected, in-situ carcinomas or treated in situ cervical epithelioma
* Presence of metastases other than hepatic (endoresection authorized)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02602756
Study Brief:
Protocol Section:
NCT02602756