Stage IV Skin MelanomaBRAFV600NCT01960634
Translational Study for BRAFV600 Serum and Plasma Determination in Patients With BRAFV600 Metastatic Melanoma
An observational study of Stage IV Skin Melanoma, run by Grupo Español Multidisciplinar de Melanoma at 13 sites in Spain.
Trial summary
This is a multi-centric translational study with biological samples collection. The aim of this study is to validate a method to detect BRAFV600 in blood samples. Samples: Blood from patients with BRAFV600 metastatic melanoma collected following standard medical practice. The treatment is not the aim of the study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stage IV Skin Melanoma
- How many people
- 58 participants
- Where
- 13 sitesSpain
- Study dates
- Apr 2013to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with histologically confirmed melanoma and BRAF V600 mutation
Who may be able to join
- Confirmed diagnosis of melanoma and BRAFV600
- Signed Informed Consent Form
- Unresectable phase III or phase IV melanoma
- The patients should be starting a treatment for melanoma (either first line or subsequent lines)
Who cannot join
None listed.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, Barcelona, 08003
Hospital Universitario Quirón Dexeus
Barcelona, Barcelona, 08028
Hospital Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35001
Hospital Infanta Cristina
Madrid, Badajoz, 06080
Hospital Ramón y Cajal
Madrid, Madrid, 28034
Hospital Costa del SOl
Marbella, Málaga, 29603
Hospital Marques de Valdecilla
Santander, Cantabria, 39008
Hospital Virgen de la Salud
Toledo, Toledo
Fundación Instituto Valenciano de Oncología
Valencia, Valencia, 46009
Hospital Miguel Servet
Zaragoza, Zaragoza, 50009
About this study
This is a multi-centric translational study with biological samples collection. The aim of this study is to validate a method to detect BRAFV600 in blood samples.
Samples: Blood from patients with BRAFV600 metastatic melanoma collected following standard medical practice.
The treatment is not the aim of the study. Patients can be treated either with specific or no-specific drug.
- Conditions
- Stage IV Skin Melanoma
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patient in which BRAF V600 in blood samples is present/absent
Measured: two years
Secondary outcomes (1)
Rate of patients with BRAFV600 present in tumor sample vs blood sample
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Skin MelanomaStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Español Multidisciplinar de Melanoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- María González Cao, MD, Study director, Hospital Universitario Quirón Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960634
- Sponsor's protocol ID
- GEM-1304
- Other IDs
- GEM-1304
- Acronym
- BRAFV600
- Status last verified
- Apr 2015
- First submitted
- 7 Oct 2013
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Study for BRAFV600 Serum and Plasma Determination in Patients With BRAFV600 Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT01960634
- Acronym / sponsor ID
- BRAFV600 / GEM-1304
- Conditions
- Stage IV Skin Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Grupo Español Multidisciplinar de MelanomaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Not posted in the source record
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 multi-centric translational study with biological samples collection. The aim of this study is to validate a method to detect BRAFV600 in blood samples.
Samples: Blood from patients with BRAFV600 metastatic melanoma collected following standard medical practice.
The treatment is not the aim of the study. Patients can be treated either with specific or no-specific drug.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with histologically confirmed melanoma and BRAF V600 mutation
Key inclusion criteria (4 listed)
- Confirmed diagnosis of melanoma and BRAFV600
- Signed Informed Consent Form
- Unresectable phase III or phase IV melanoma
- The patients should be starting a treatment for melanoma (either first line or subsequent lines)
Key exclusion criteria (0 listed)
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
Rate of patient in which BRAF V600 in blood samples is present/absent
Time frame: two years
1 secondary outcome
Rate of patients with BRAFV600 present in tumor sample vs blood sample
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
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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.
María González Cao, MD study director
Hospital Universitario Quirón Dexeus
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage IV Skin Melanoma, run by Grupo Español Multidisciplinar de Melanoma at 13 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 4 inclusion and 0 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 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of patient in which BRAF V600 in blood samples is present/absent (time frame: two years). 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 5 May 2015.