Comparison of In-House Methods and Cobas BRAF V600 Mutation Assay in Melanoma Tumor Samples

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01744860
First received: December 6, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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


Condition
Malignant Melanoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Concordance Between the Cobas® BRAF V600 Mutation Assay and the Methods Used in INCa Platforms for Detection of BRAF V600 Mutations in Melanoma in Real Life Setting

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • BRAF mutation status of melanoma tumor samples according to cobas® 4800 BRAF V600 Mutation Test vs. INCa laboratories molecular genetics platform [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Type of tumor sample [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]
  • Type of pre-analytical method used in the preparation of the tumor sample for BRAF V600 mutation detection [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]
  • Final result for BRAF V600 mutation detection [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]

Enrollment: 420
Study Start Date: December 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

No patients are enrolled. Use of tumor samples only.

  • Fixative unknown
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744860

Locations
France
Boulogne Billancourt, France, 92104
Colmar, France, 68024
Lille, France, 59037
Lyon, France, 69437
Marseille, France, 13015
Montpellier, France, 34295
Nantes, France, 44093
Paris, France, 75010
Pessac, France, 33604
Rouen, France, 76031
Vandoeuvre Les Nancy, France, 54511
Villejuif, France, 94505
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01744860     History of Changes
Other Study ID Numbers: ML28471
Study First Received: December 6, 2012
Last Updated: August 4, 2014
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 18, 2014