Endoresection of the Tumor Scar or Transpupillary Thermot... | NCT02874040

Studies
Endoresection of the Tumor Scar or Transpupillary Thermotherapy for the Treatment of Large Uveal Melanomas (Endoresection-Laser)

NCT02874040

Sponsor

Institut Curie

Status

Completed

Last Update Posted

Aug 8, 2025Actual

Enrollment

87Actual

Phase

Not Applicable

Conditions

Uveal Melanoma
Melanoma, Uveal

Interventions

Endoresection
Laser diode

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 19, 2013Actual

Primary Completion Date

Oct 24, 2023Actual

Completion Date

Oct 24, 2024Actual

First Submitted Date

Aug 11, 2016

First Submission Date that Met QC Criteria

Aug 16, 2016

First Posted Date

Aug 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2025

Last Update Posted Date

Aug 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Study the efficacy of endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar to prevent neovascular glaucoma and secondary enucleation

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar	Procedure: Endoresection Procedure: Laser diode

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoresection	Procedure	Endoresection of the tumor scar	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-treatment complication incidence.	observed complications are : Number of glaucomas, numbrer of retinal detachment and number of secondary enucleations.	3 years

Secondary Outcomes

Measure	Description	Time Frame
Measure of tumor scar thickness		3 years
Toxicity and side effects evaluation according to NCI-CTCAE v4.0 scale		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Tumor of 7 mm of thickness or more
Patients treated by proton beam therapy
Patients aged at least 18 years
Patients clearly informed of the study, having received the letter of information and signed the consent

Exclusion Criteria:

Massive extrascleral extension posterior to the equator
Patients with metastasis at diagnosis.
Patients with glaucoma before the radiation therapy
Patients with opaque media preventing transpupillary thermotherapy
Patients for whom follow up will be difficult due to geographical, social or psychological reasons

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nathalie CASSOUX, MD, PhD	Institut Curie	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Curie		Paris		75005	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000098943	Uveal Melanoma

Ancestor Terms

ID	Term
D008545	Melanoma
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054023	Lasers, Semiconductor
D006979	Hyperthermia, Induced

Ancestor Terms

ID	Term
D007834	Lasers
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided