Study to Analyze Mutations in V600 BRAF Oncogen in Participants With Metastatic Melanoma

Metastatic Cancers Clinical Trial

Official title:

Epidemiological Study of V600 BRAF Mutation in Spanish Patients Diagnosed With Metastatic Melanoma: ABSOLUT-BRAF Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663232
• Other study ID #: ML30089
• Status: Completed
• Start date: June 2013
• Est. completion date: October 2014

Study information

• Verified date: June 2023
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a national, multicenter, cross-sectional epidemiological study in adult Spanish participants diagnosed with advanced or metastatic melanoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Valid tumor samples from participants diagnosed with Stage IIIc or IV melanoma

• Written informed consent granted

Exclusion Criteria:

• Do not fulfill one or more inclusion criteria

Related Conditions & MeSH terms

• Melanoma
• Metastatic Cancers

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With V600 BRAF Mutation Status	Presence or absence of mutations in the V600 BRAF oncogene was determined in all eligible participants. Data collection and management of BRAF mutation testing was carried out using the Biomarker point® online platform. The platform was used as an electronic case report form (e-CRF) for collecting information in electronic format via a website. Percentage of participants with BRAF mutation status (mutated BRAF, wild type, not available) were reported.	Day 1
Secondary	Percentage of Participants Categorized by Melanoma Stage	Melanoma stages were categorized (according to American Joint Committee on Cancer [AJCC]) as IIIc (advanced stage of melanoma), M1a (metastases to skin, subcutaneous, or distant lymph nodes, normal lactate dehydrogenase (LDH) level, M1b (lung metastases, normal LDH) and M1c (metastases to all other visceral sites and normal LDH or distant metastases to any site combined with an elevated serum LDH level). Of these Stage IIIc was used as the referral category for comparisons.	Day 1
Secondary	Percentage of Participants With Family History of Melanoma		Day 1
Secondary	Percentage of Participants With Sun Exposure	Data were obtained to classify the population with sun exposure as those with low, intermittent or chronic exposure. For the sub-analysis of low, intermittent and chronic exposure, percentages were calculated based on the population with any sun exposure.	Day 1
Secondary	Percentage of Participants Categorized by Primary Tumor Location	Primary tumor location included limbs (upper and lower extremities), trunk, head/neck, mucosa, uveal, acral, other (other than these specified locations), unknown (exact location unknown), and not available.	Day 1
Secondary	Percentage of Participants Categorized By LDH Level	Normal LDH levels range from 140 units per liter (U/L) to 280 U/L.	Day 1
Secondary	Median Time Since Diagnosis of Melanoma	Median time from the diagnosis of primary melanoma to advanced disease was determined in years.	Day 1
Secondary	Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)		Day 1
Secondary	Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other)		Day 1
Secondary	Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others)		Day 1
Secondary	Percentage of Participants Categorized by Breslow Thickness	Breslow thickness is defined as the total vertical height of the melanoma, from the very top (called the granular layer) to the area of deepest penetration in the skin. An instrument called an ocular micrometer is used to measure the thickness of the excised (removed) tumor. In general, the higher the Breslow thickness, the worse the prognosis. The classifications were lesser than or equal to (=) 1.0 millimeters (mm), 1.01 - 2.0 mm, 2.01 - 4.0 mm, greater than (>) 4.0 mm and Unknown.	Day 1
Secondary	Percentage of Participants With Ulceration		Day 1
Secondary	Percentage of Participants With Regression	Regression in melanoma is the replacement of tumor tissue with fibrosis, degenerated melanoma cells, lymphocytic proliferation, and telangiectasia formation.	Day 1
Secondary	Percentage of Participants With Vascular Invasion	Vascular invasion is defined as the appearance of cancer cells in the lymphatic and blood streams.	Day 1
Secondary	Percentage of Participants Categorized by Method of DNA Extraction (Cobas® BRAF V600 Mutation Test or Others)		Day 1
Secondary	Percentage of Participants Categorized by Method of BRAF Mutation Testing (Cobas® 4800 BRAF V600 Mutation Test or Others)		Day 1
Secondary	Percentage Participants Categorized by the Percentage of Tumor Cells Referred to the Technique	The samples were classified based on the percentage of tumor cells referred to the technique as follows: <60 percent (%), 60-80%, >80% and Unknown.	Day 1
Secondary	Percentage of Participants With Adequate Quality/Quantity of Tumor Sample		Day 1