MelanomaNCT02775643
Molecular Analysis of Childhood and Adolescent Melanocytic Lesions
An observational study of Melanoma, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
This is an observational, non-therapeutic study to collect clinical and molecular information of pediatric patients with childhood melanocytic lesions. PRIMARY OBJECTIVE: To perform a comprehensive molecular analysis of samples either from paraffin embedded and/or frozen tissue from patients with pediatric melanocytic… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Melanoma
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2016to 31 May 2041
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants who meet inclusion criteria and consent to enrollment on the study at St. Jude Children's Research Hospital (SJCRH).
Who may be able to join
- Participant has a suspected or confirmed diagnosis of a melanocytic lesion, including:
- Conventional or "adult-type" melanoma
- Spitzoid melanoma/atypical Spitz tumor
- Congenital melanoma
- Melanoma arising in a giant congenital nevus
- Melanocytic lesions with indeterminate biological behavior (e.g., pigment synthesizing melanomas)
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- Participant was <19 years of age at the time of diagnosis.
- Tissue is available for biologic studies.
- Participant has been enrolled on the TBANK protocol at SJCRH, or will be enrolled before any research tests are performed on their biological materials.
Who cannot join
- Ocular melanoma
- Inability or unwillingness of research participant or legal guardian to consent.
- Histologic diagnosis other than melanocytic lesion described in 3.1.1.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Alberto Pappo, MD, 866-278-5833, referralinfo@stjude.org
Alberto Pappo, MD
About this study
This is an observational, non-therapeutic study to collect clinical and molecular information of pediatric patients with childhood melanocytic lesions.
PRIMARY OBJECTIVE: To perform a comprehensive molecular analysis of samples either from paraffin embedded and/or frozen tissue from patients with pediatric melanocytic lesions (including melanoma, spitzoid melanoma, congenital melanoma, melanoma arising in giant nevi).
SECONDARY OBJECTIVE: To collect minimal information on patients treated with adjuvant or systemic therapies according to National Comprehensive Cancer Network (NCCN) guidelines.
Read the detailed description
Investigators will study the DNA and RNA in tumor cells and blood cells to look for changes that may be related to the development of the tumor, as well as changes that may influence how the tumor responds or doesn't respond to treatment. Normal blood cells will be studied to compare to the tumor cells. Investigators will also look at basic information about the treatment received and how the tumor responds, i.e. what kind of chemotherapy, surgery, radiation treatment, or other therapy the participant received, whether they had serious side effects, and how well the tumor responded to the treatment.
As part of regular medical care, tumor will be obtained to determine the type of cancer. For participants who consent to this study, leftover tumor tissue not needed for diagnosis or regular medical care will be studied at St. Jude Children's Research Hospital where scientists will look for changes in the genes of the tumor cells. No additional surgeries or procedures are needed for this study. A small amount of blood (2-3 tablespoons) will be collected and analyzed to determine if the genetic changes in the tumor cells are also found in the blood cells. Small children (<42 lbs.) will have a smaller amount drawn (1-2 tablespoons).
- Conditions
- Melanoma
- Keywords
- Melanoma, Spitzoid Melanoma, Congenital Melanoma, Melanoma Arising in Giant Nevi, Melanocytic lesions with indeterminate biological behavior, Pigment synthesizing melanomas
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic profile
Pathology/molecular samples may be available in pathology banking system or may be obtained at the same time as specimens are taken from individual consenting participants (time varies according to specific therapeutic protocol). A comprehensive molecular analysis of tumor samples either from paraffin embedded and/or frozen tissue from patients will be performed. Summary statistics will be calculated for the pathology/molecular data.
Measured: At participant enrollment
Secondary outcomes (1)
Overall Survival (OS)
OS will be calculated as time from date of diagnosis to date of death or date of last follow-up up to 10 years. OS will be estimated by Kaplan-Meier method.
Measured: Up to 10 years following on-study date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study start31 May 2016
- Primary completion31 May 2031 (estimated)
- Study completion31 May 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alberto Pappo, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775643
- Sponsor's protocol ID
- MACMEL
- Status last verified
- Nov 2025
- First submitted
- 12 May 2016
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Analysis of Childhood and Adolescent Melanocytic Lesions
- ClinicalTrials.gov ID
- NCT02775643
- Acronym / sponsor ID
- MACMEL
- Conditions
- Melanoma
- Keywords
- Melanoma, Spitzoid Melanoma, Congenital Melanoma, Melanoma Arising in Giant Nevi, Melanocytic lesions with indeterminate biological behavior, Pigment synthesizing melanomas
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 31 May 2016 (actual)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 31 May 2041 (estimated)
- First posted
- 17 May 2016 (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 an observational, non-therapeutic study to collect clinical and molecular information of pediatric patients with childhood melanocytic lesions.
PRIMARY OBJECTIVE: To perform a comprehensive molecular analysis of samples either from paraffin embedded and/or frozen tissue from patients with pediatric melanocytic lesions (including melanoma, spitzoid melanoma, congenital melanoma, melanoma arising in giant nevi).
SECONDARY OBJECTIVE: To collect minimal information on patients treated with adjuvant or systemic therapies according to National Comprehensive Cancer Network (NCCN) guidelines.
Detailed description
Investigators will study the DNA and RNA in tumor cells and blood cells to look for changes that may be related to the development of the tumor, as well as changes that may influence how the tumor responds or doesn't respond to treatment. Normal blood cells will be studied to compare to the tumor cells. Investigators will also look at basic information about the treatment received and how the tumor responds, i.e. what kind of chemotherapy, surgery, radiation treatment, or other therapy the participant received, whether they had serious side effects, and how well the tumor responded to the treatment.
As part of regular medical care, tumor will be obtained to determine the type of cancer. For participants who consent to this study, leftover tumor tissue not needed for diagnosis or regular medical care will be studied at St. Jude Children's Research Hospital where scientists will look for changes in the genes of the tumor cells. No additional surgeries or procedures are needed for this study. A small amount of blood (2-3 tablespoons) will be collected and analyzed to determine if the genetic changes in the tumor cells are also found in the blood cells. Small children (<42 lbs.) will have a smaller amount drawn (1-2 tablespoons).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants who meet inclusion criteria and consent to enrollment on the study at St. Jude Children's Research Hospital (SJCRH).
Key inclusion criteria (9 listed)
- Participant has a suspected or confirmed diagnosis of a melanocytic lesion, including:
- Participant was <19 years of age at the time of diagnosis.
- Tissue is available for biologic studies.
- Participant has been enrolled on the TBANK protocol at SJCRH, or will be enrolled before any research tests are performed on their biological materials.
Key exclusion criteria (3 listed)
- Ocular melanoma
- Inability or unwillingness of research participant or legal guardian to consent.
- Histologic diagnosis other than melanocytic lesion described in 3.1.1.
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
Genomic profile
Time frame: At participant enrollment
Pathology/molecular samples may be available in pathology banking system or may be obtained at the same time as specimens are taken from individual consenting participants (time varies according to specific therapeutic protocol). A comprehensive molecular analysis of tumor samples either from paraffin embedded and/or frozen tissue from patients will be performed. Summary statistics will be calculated for the pathology/molecular data.
1 secondary outcome
Overall Survival (OS)
Time frame: Up to 10 years following on-study date
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
Alberto Pappo, MD principal investigator
St. Jude Children's Research Hospital
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 Melanoma, run by St. Jude Children's Research Hospital at 1 site in United States.
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 9 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 10 Nov 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto Pappo, MD (866-278-5835, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic profile (time frame: At participant enrollment). 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 10 Nov 2025.