Comparison of In-House Methods and Cobas BRAF V600 Mutation Assay in Melanoma Tumor Samples
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01744860
First received: December 6, 2012
Last updated: June 3, 2013
Last verified: June 2013
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Purpose
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.
| 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) |
| Groups/Cohorts |
|---|
| Cohort |
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
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: | June 3, 2013 |
| 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 June 13, 2013