NCT01334008

Brief Summary

Circulating tumor DNA detection and quantification in patients with metastatic choroidal melanoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

10 months

First QC Date

March 31, 2011

Last Update Submit

November 19, 2025

Conditions

Choroidal Melanoma, Diffuse

Keywords

Circulating tumor DNAChoroidal Melanoma

Outcome Measures

Primary Outcomes (1)

  • Assessment and development of circulating tumor DNA detection techniques

    Quantification of circulating tumor DNA in blood samples. Results expressed in number of samples where circulating DNA is present.

    2 years

Secondary Outcomes (1)

  • Detection technique comparison (PAP (pyrophosphorolysis activated polymerisation), BEAMing, NGS(next sequencing generation)) in terms of feasibility, robustness, sensitivity and cost.

    2 years

Study Arms (1)

Blood sampling

OTHER
Biological: Blood sampling

Interventions

Blood samplingBIOLOGICAL

30ml of patient peripherical blood will be collected

Blood sampling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> or = 18 years.
  • Patient with a metastatic choroidal melanoma.
  • Patient with tumor or metastasis available for GNAQ (Guanine nucleotide blinding protein) status characterization.
  • Patient able to stand a blood collection.
  • Signed written informed consent approved by competent authority and ethic committee.

You may not qualify if:

  • Patient without social protection/insurance.
  • Current pregnancy and lactation.
  • All social, medical, psychological, situations making the study impossible.
  • Person deprived of liberty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Curie

Paris, 75005, France

Location

Related Publications (1)

  • Bidard FC, Madic J, Mariani P, Piperno-Neumann S, Rampanou A, Servois V, Cassoux N, Desjardins L, Milder M, Vaucher I, Pierga JY, Lebofsky R, Stern MH, Lantz O. Detection rate and prognostic value of circulating tumor cells and circulating tumor DNA in metastatic uveal melanoma. Int J Cancer. 2014 Mar 1;134(5):1207-13. doi: 10.1002/ijc.28436. Epub 2013 Sep 3.

    PMID: 23934701RESULT

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Sophie PIPERNO-NEUMANN, 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

March 31, 2011

First Posted

April 12, 2011

Study Start

April 1, 2011

Primary Completion

February 1, 2012

Study Completion

May 1, 2012

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

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)