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

June 29, 2023 updated by: Hoffmann-La Roche

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
264

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08916
      • Burgos, Spain, 09006
      • Caceres, Spain, 10003
      • Castellon, Spain, 12002
      • Girona, Spain, 17007
      • Granada, Spain, 18014
      • Lerida, Spain, 25198
      • Madrid, Spain, 28046
      • Madrid, Spain, 28034
      • Madrid, Spain, 28041
      • Madrid, Spain, 28007
      • Madrid, Spain, 28002
      • Malaga, Spain, 29010
      • Murcia, Spain, 30120
      • Salamanca, Spain, 37007
      • Sevilla, Spain, 41009
      • Toledo, Spain, 45004
      • Valencia, Spain, 46017
      • Valencia, Spain, 41014
      • Zaragoza, Spain, 50009
    • Asturias
      • Oviedo, Asturias, Spain, 33011
    • Cadiz
      • Jerez de La Frontera, Cadiz, Spain, 11407
    • Cantabria
      • Santander, Cantabria, Spain, 39008
    • Guipuzcoa
      • Donostia, Guipuzcoa, Spain, 20080
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07198
    • LA Coruña
      • A Coruña, LA Coruña, Spain, 15006
    • Murcia
      • Cartagena (Murcia), Murcia, Spain, 30202
    • Navarra
      • Pamplona, Navarra, Spain, 31008
    • Tenerife
      • Santa Cruz de Tenerife, Tenerife, Spain, 38010
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants diagnosed with metastatic melanoma who have valid samples for BRAF mutation testing and give their informed consent will be included in this trial.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Metastatic melanoma
Participants with metastatic melanoma who attend their physicians during the 18-month recruitment period and have valid biological samples available for BRAF mutation testing will be included in the study. There will be no intervention in this study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With V600 BRAF Mutation Status
Time Frame: Day 1
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Categorized by Melanoma Stage
Time Frame: Day 1
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
Percentage of Participants With Family History of Melanoma
Time Frame: Day 1
Day 1
Percentage of Participants With Sun Exposure
Time Frame: Day 1
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
Percentage of Participants Categorized by Primary Tumor Location
Time Frame: Day 1
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
Percentage of Participants Categorized By LDH Level
Time Frame: Day 1
Normal LDH levels range from 140 units per liter (U/L) to 280 U/L.
Day 1
Median Time Since Diagnosis of Melanoma
Time Frame: Day 1
Median time from the diagnosis of primary melanoma to advanced disease was determined in years.
Day 1
Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)
Time Frame: Day 1
Day 1
Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other)
Time Frame: Day 1
Day 1
Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others)
Time Frame: Day 1
Day 1
Percentage of Participants Categorized by Breslow Thickness
Time Frame: Day 1
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
Percentage of Participants With Ulceration
Time Frame: Day 1
Day 1
Percentage of Participants With Regression
Time Frame: Day 1
Regression in melanoma is the replacement of tumor tissue with fibrosis, degenerated melanoma cells, lymphocytic proliferation, and telangiectasia formation.
Day 1
Percentage of Participants With Vascular Invasion
Time Frame: Day 1
Vascular invasion is defined as the appearance of cancer cells in the lymphatic and blood streams.
Day 1
Percentage of Participants Categorized by Method of DNA Extraction (Cobas® BRAF V600 Mutation Test or Others)
Time Frame: Day 1
Day 1
Percentage of Participants Categorized by Method of BRAF Mutation Testing (Cobas® 4800 BRAF V600 Mutation Test or Others)
Time Frame: Day 1
Day 1
Percentage Participants Categorized by the Percentage of Tumor Cells Referred to the Technique
Time Frame: Day 1
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
Percentage of Participants With Adequate Quality/Quantity of Tumor Sample
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML30089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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