Circulating Tumoral DNA in Choroidal Melanoma (ctDNA MU)

NCT02875652 | Completed

• 1 other identifier: IC 2012-08
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Quantification and follow-up during 3 years of circulating tumoral DNA in patients with choroidal melanoma

Conditions

Choroidal Melanoma

Keywords

circulation tumor DNA; choroidal melanoma

Outcome Measures

Primary Outcomes (1)

• Assesment of the change of the circulating tumor DNA from baseline at 3 years

  T0: before treatment; T1: 1 month after local treatment; T2: at 7 months; Tn : every 6 months up to 3 years.

Secondary Outcomes (2)

• Compare the treatment effects of the primary tumor (protontherapy, iodine plaque, enucleation) on the rate of circulating tumoral DNA.

  3 years

• Comparison of the circulating tumor DNA rate to hepatic imaging if available.

  3 years

Study Arms (1)

Blood sampling

EXPERIMENTAL

Biological: Blood sampling

Interventions

Blood sampling BIOLOGICAL

3 vials of 7,5 ml of peripherical blood will be collected at each blood sample.

Blood sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years old or more.
• Patient with a recent choroidal melanoma before the start of the specific treatment.
• Patient able to stand a blood collection.
• Work-up for extension (CT).
• Patient explanation given and consent information signed or by legal representative

You may not qualify if:

• Patient without social protection / insurance.
• Person deprived of liberty or under guardianship.
• Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

Institut Curie

Paris, 75005, France

Location

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Laurence Desjardins, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 23, 2016
• Study Start: March 21, 2013
• Primary Completion: April 2, 2019
• Study Completion: April 2, 2019
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (1)