Metastatic CancersNCT02663232
Study to Analyze Mutations in V600 BRAF Oncogen in Participants With Metastatic Melanoma
An observational study of Metastatic Cancers, run by Hoffmann-La Roche at 33 sites in Spain.
Trial summary
This is a national, multicenter, cross-sectional epidemiological study in adult Spanish participants diagnosed with advanced or metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancers
- How many people
- 264 participants
- Where
- 33 sitesSpain
- Study dates
- Jun 2013to Oct 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Valid tumor samples from participants diagnosed with Stage IIIc or IV melanoma
- Written informed consent granted
Who cannot join
- Do not fulfill one or more inclusion criteria
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Spain33 sites
Study site
A Coruña, LA Coruña, 15006
Study site
Barcelona, 08003
Study site
Barcelona, 08035
Study site
Barcelona, 08036
Study site
Barcelona, 08916
Study site
Bilbao, Vizcaya, 48013
Study site
Burgos, 09006
Study site
Cáceres, 10003
Study site
Cartagena (Murcia), Murcia, 30202
Study site
Castellon, Castellon, 12002
Study site
Donostia / San Sebastian, Guipuzcoa, 20080
Study site
Girona, 17007
Study site
Granada, 18014
Study site
Jerez de la Frontera, Cadiz, 11407
Study site
Lleida, 25198
Study site
Madrid, 28002
Study site
Madrid, 28007
Study site
Madrid, 28034
Study site
Madrid, 28041
Study site
Madrid, 28046
Study site
Málaga, 29010
Study site
Murcia, 30120
Study site
Oviedo, Principality of Asturias, 33011
Study site
Palma de Mallorca, Balearic Islands, 07198
Study site
Pamplona, Navarre, 31008
Study site
Salamanca, 37007
Study site
Santa Cruz de Tenerife, Tenerife, 38010
Study site
Santander, Cantabria, 39008
Study site
Seville, 41009
Study site
Toledo, 45004
Study site
Valencia, 41014
Study site
Valencia, 46017
Study site
Zaragoza, 50009
About this study
Official title: 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.
- Conditions
- Metastatic Cancers
- Keywords
- V600 BRAF mutation, Metastatic melanoma
- Medical subject headings
- Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (17)
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.
Measured: Day 1
Percentage of Participants With Family History of Melanoma
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Percentage of Participants Categorized By LDH Level
Normal LDH levels range from 140 units per liter (U/L) to 280 U/L.
Measured: Day 1
Median Time Since Diagnosis of Melanoma
Median time from the diagnosis of primary melanoma to advanced disease was determined in years.
Measured: Day 1
Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)
Measured: Day 1
Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other)
Measured: Day 1
Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others)
Measured: Day 1
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.
Measured: Day 1
Percentage of Participants With Ulceration
Measured: Day 1
Percentage of Participants With Regression
Regression in melanoma is the replacement of tumor tissue with fibrosis, degenerated melanoma cells, lymphocytic proliferation, and telangiectasia formation.
Measured: Day 1
Percentage of Participants With Vascular Invasion
Vascular invasion is defined as the appearance of cancer cells in the lymphatic and blood streams.
Measured: Day 1
Percentage of Participants Categorized by Method of DNA Extraction (Cobas® BRAF V600 Mutation Test or Others)
Measured: Day 1
Percentage of Participants Categorized by Method of BRAF Mutation Testing (Cobas® 4800 BRAF V600 Mutation Test or Others)
Measured: Day 1
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.
Measured: Day 1
Percentage of Participants With Adequate Quality/Quantity of Tumor Sample
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJun 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic CancersStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663232
- Sponsor's protocol ID
- ML30089
- Status last verified
- Jun 2023
- First submitted
- 20 Nov 2015
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of V600 BRAF Mutation in Spanish Patients Diagnosed With Metastatic Melanoma: ABSOLUT-BRAF Study
- ClinicalTrials.gov ID
- NCT02663232
- Acronym / sponsor ID
- ML30089
- Conditions
- Metastatic Cancers
- Keywords
- V600 BRAF mutation, Metastatic melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Posted 5 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a national, multicenter, cross-sectional epidemiological study in adult Spanish participants diagnosed with advanced or metastatic melanoma.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Valid tumor samples from participants diagnosed with Stage IIIc or IV melanoma
- Written informed consent granted
Key exclusion criteria (1 listed)
- Do not fulfill one or more inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
17 secondary outcomes
Percentage of Participants Categorized by Melanoma Stage
Time frame: Day 1
Percentage of Participants With Family History of Melanoma
Time frame: Day 1
Percentage of Participants With Sun Exposure
Time frame: Day 1
Percentage of Participants Categorized by Primary Tumor Location
Time frame: Day 1
Percentage of Participants Categorized By LDH Level
Time frame: Day 1
Median Time Since Diagnosis of Melanoma
Time frame: Day 1
Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)
Time frame: 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
Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others)
Time frame: Day 1
Percentage of Participants Categorized by Breslow Thickness
Time frame: Day 1
Percentage of Participants With Ulceration
Time frame: Day 1
Percentage of Participants With Regression
Time frame: Day 1
Percentage of Participants With Vascular Invasion
Time frame: Day 1
Percentage of Participants Categorized by Method of DNA Extraction (Cobas® BRAF V600 Mutation Test or Others)
Time frame: Day 1
Percentage of Participants Categorized by Method of BRAF Mutation Testing (Cobas® 4800 BRAF V600 Mutation Test or Others)
Time frame: Day 1
Percentage Participants Categorized by the Percentage of Tumor Cells Referred to the Technique
Time frame: Day 1
Percentage of Participants With Adequate Quality/Quantity of Tumor Sample
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancers, run by Hoffmann-La Roche at 33 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With V600 BRAF Mutation Status (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.