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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Spain

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.

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 groups in NCT02663232
Study groupRoleWhat they receive
Metastatic melanomaParticipants 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.

  1. 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)

  1. 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

  2. Percentage of Participants With Family History of Melanoma

    Measured: Day 1

  3. 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

  4. 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

  5. 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

  6. Median Time Since Diagnosis of Melanoma

    Median time from the diagnosis of primary melanoma to advanced disease was determined in years.

    Measured: Day 1

  7. Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)

    Measured: Day 1

  8. Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other)

    Measured: Day 1

  9. Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others)

    Measured: Day 1

  10. 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

  11. Percentage of Participants With Ulceration

    Measured: Day 1

  12. 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

  13. 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

  14. Percentage of Participants Categorized by Method of DNA Extraction (Cobas® BRAF V600 Mutation Test or Others)

    Measured: Day 1

  15. Percentage of Participants Categorized by Method of BRAF Mutation Testing (Cobas® 4800 BRAF V600 Mutation Test or Others)

    Measured: Day 1

  16. 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

  17. 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.

  1. First posted26 Jan 2016 (estimated)
  2. Study startJun 2013
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT02663232.

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.

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