NCT01744860

Brief Summary

This non-interventional study will compare the Cobas BRAF V600 mutation assay with in-house methods used in molecular laboratories for the assessment of the BRAF mutation status in melanoma tumor samples. No patients will be enrolled in this study. Data will be collected for approximately 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
420

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Shorter than P25 for all trials

Geographic Reach
1 country

12 active sites

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

Study Start

First participant enrolled

December 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
3 years until next milestone

Results Posted

Study results publicly available

March 28, 2016

Completed
Last Updated

March 28, 2016

Status Verified

November 1, 2015

Enrollment Period

4 months

First QC Date

December 6, 2012

Results QC Date

January 21, 2016

Last Update Submit

February 25, 2016

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

  • BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories

    BRAF V600 mutation status was determined by INCa molecular laboratories "in-house" methods and Cobas 4800 BRAF V600 mutation test. Samples were analysed as V600 mutation, No V600 mutation and Non evaluable. Additionally, the type of V600 mutation (E, K, R, D, E2, other V600 mutation, not specified) was also evaluated only by INCa molecular laboratory "in-house" method.

    Up to 6 months

Secondary Outcomes (28)

  • Tumor Sample Characteristics-Type of Tumor Sample

    Up to 6 months

  • Tumor Sample Characteristics - Source of Tumor Sample

    Up to 6 months

  • Type of Pathology Laboratory Performing the Fixation or Embedding-Pre-analytical Method

    Up to 6 months

  • Time From Sampling to Fixation- Pre-analytical Method

    Up to 6 months

  • Type of Fixative Used- Pre-analytical Method

    Up to 6 months

  • +23 more secondary outcomes

Study Arms (2)

INCa molecular genetics laboratory "in-house" methods

BRAF V600 mutations were analysed using INCa (Institut National du Cancer \[French National Cancer Institute\]) molecular genetics laboratories using "in-house" methods

Cobas 4800 Mutation Test

BRAF V600 mutations were analysed using Cobas 4800 mutation test

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

No patients are enrolled in this study. Use of melanoma tumor samples.

You may qualify if:

  • No patients are enrolled. Use of tumor samples only.
  • Histologically proven melanoma tumor sample
  • Any type of tumor sample: biopsy or surgical specimen of primary tumor or metastasis
  • Tumor samples must be fixed and paraffin-embedded.

You may not qualify if:

  • No patients are enrolled. Use of tumor samples only.
  • Fixative unknown

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Boulogne-Billancourt, 92104, France

Location

Unknown Facility

Colmar, 68024, France

Location

Unknown Facility

Lille, 59037, France

Location

Unknown Facility

Lyon, 69437, France

Location

Unknown Facility

Marseille, 13015, France

Location

Unknown Facility

Montpellier, 34295, France

Location

Unknown Facility

Nantes, 44093, France

Location

Unknown Facility

Paris, 75010, France

Location

Unknown Facility

Pessac, 33604, France

Location

Unknown Facility

Rouen, 76031, France

Location

Unknown Facility

Vandœuvre-lès-Nancy, 54511, France

Location

Unknown Facility

Villejuif, 94505, France

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Roche Trial Information Hotline
Organization
F. Hoffmann-La Roche AG
global.trial_information@roche.com
+41 61 6878333

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2012

First Posted

December 7, 2012

Study Start

December 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

March 28, 2016

Results First Posted

March 28, 2016

Record last verified: 2015-11

Locations

FR(12)