Cutaneous MelanomaNCT04625491
Location of Lower Limb Cutaneous Melanomas as a Prognostic Factor.
An observational study of Cutaneous Melanoma and Anatomical Pathological Condition, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
Trial summary
Observational study to know the relevance of specific anatomical location of cutaneous melanoma on lower limbs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cutaneous Melanoma, Anatomical Pathological Condition
- What is being tested?
- Observational
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2000to Dec 2021
- How long will I take part?
- 10 Years
- 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 that were cared of cutaneous melanoma on the lower limb.
Who may be able to join
- Cutaneous melanoma on the lower limb
Who cannot join
- Incomplete staging
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario "Virgen de la Arrixaca"
Murcia, 30120
Antonio Piñero, MD PhD, antonio.pinero@carm.es
Antonio Piñero, MD PhD
About this study
Official title: Lower Limb Cutaneous Melanoma: Observational Prognostic Study About Specific Location of the Primary Lesion.
Observational study to know the relevance of specific anatomical location of cutaneous melanoma on lower limbs.
Read the detailed description
Ambispective (retrospective and prospective) observational register of patients with cutaneous melanoma on lower limbs are grouped in 1) proximal (thigh), 2) medium (leg), and 3) distal (ankle and foot) location. Analysis of melanoma-specific overall and disease-free survival will be made, as well as multivariant analysis for prognostic variables including anatomical location.
- Being tested
- Observational
- Keywords
- cutaneous melanoma, lower limb, prognostic
- Medical subject headings
- Melanoma, Pathological Conditions, Anatomical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| Location on lower limb | Proximal (thigh) Medium (leg) Distal (ankle and foot) Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melanoma-specific overall survival
Melanoma-specific overall survival
Measured: Ten years
Melanoma-specific disease-free survival
Melanoma-specific disease-free survival
Measured: Ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start1 Jan 2000
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous 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
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Pinero-Madrona, Hospital Universitario Virgen de la Arrixaca
- Investigators
- Antonio Piñero-Madrona, MD PhD, Principal investigator, Associate Professor of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625491
- Sponsor's protocol ID
- 2020-4-2-HUVA
- Status last verified
- Feb 2021
- First submitted
- 6 Nov 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: An interim analysis of data is planned in 2020.
Publications
Pinero-Madrona A, Cerezuela-Fuentes P, Ruiz-Merino G, Martinez-Barba E, Ortiz-Reina S, Martinez-Ortiz MJ, Lopez-Avila A, Frias-Iniesta JF, Viney A, Cabezas-Herrera J. Lower limb cutaneous melanoma surgery: location matters. Arch Dermatol Res. 2023 Sep;315(7):1971-1978. doi: 10.1007/s00403-023-02571-z. Epub 2023 Mar 2.
PubMed 36862181
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Limb Cutaneous Melanoma: Observational Prognostic Study About Specific Location of the Primary Lesion.
- ClinicalTrials.gov ID
- NCT04625491
- Acronym / sponsor ID
- 2020-4-2-HUVA
- Keywords
- cutaneous melanoma, lower limb, prognostic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 12 Nov 2020 (actual)
- 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.
Observational study to know the relevance of specific anatomical location of cutaneous melanoma on lower limbs.
Detailed description
Ambispective (retrospective and prospective) observational register of patients with cutaneous melanoma on lower limbs are grouped in 1) proximal (thigh), 2) medium (leg), and 3) distal (ankle and foot) location. Analysis of melanoma-specific overall and disease-free survival will be made, as well as multivariant analysis for prognostic variables including anatomical location.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Location on lower limb | – | Other: ObservationalProximal (thigh) Medium (leg) Distal (ankle and foot) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that were cared of cutaneous melanoma on the lower limb.
Key inclusion criteria (1 listed)
- Cutaneous melanoma on the lower limb
Key exclusion criteria (1 listed)
- Incomplete staging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational | Other | Location on lower limb |
Primary outcome
Melanoma-specific overall survival
Time frame: Ten years
Melanoma-specific overall survival
Melanoma-specific disease-free survival
Time frame: Ten years
Melanoma-specific disease-free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Derived from this study: PubMed 36862181Pinero-Madrona A, Cerezuela-Fuentes P, Ruiz-Merino G, Martinez-Barba E, Ortiz-Reina S, Martinez-Ortiz MJ, Lopez-Avila A, Frias-Iniesta JF, Viney A, Cabezas-Herrera J. Lower limb cutaneous melanoma surgery: location matters. Arch Dermatol Res. 2023 Sep;315(7):1971-1978. doi: 10.1007/s00403-023-02571-z. Epub 2023 Mar 2.
- Individual participant dataSharing planned: No. An interim analysis of data is planned in 2020.
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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.
Antonio Piñero-Madrona, MD PhD principal investigator
Associate Professor of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Melanoma and Anatomical Pathological Condition, run by Hospital Universitario Virgen de la Arrixaca at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Piñero-Madrona, MD PhD (+34 968369500 ext. 9677, pineromadrona@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melanoma-specific overall survival (time frame: Ten years). The study lists 2 primary outcomes in all. 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 NCT04625491, which also lists 1 linked publication.
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 10 Feb 2021.