Melanoma of SkinMol-MelNCT06602648
MELCAYA - Novel Health Care Strategies for Melanoma in Children, Adolescents, and Young Adults - Work Package 3 (WP3)
An observational study of Melanoma of Skin, run by University of Florence at 1 site in Italy.
Trial summary
The aim of this study is to investigate a type of skin cancer, also known as melanoma, in children, adolescents, and young adults, who will be referred to as CAYA patients in this project. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Melanoma of Skin
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 17 Apr 2024to Nov 2026
- 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 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study will focus on CAYA (\< 30 y.o) patients with histologically confirmed melanoma or intermediate/ambiguous melanocytic neoplasm (i.e.,melanocytomas, SAMPUS, IAMPUS and MELTUMP according to WHO classification).The population include patients of both genders.
Who may be able to join
- adolescent and childhood patients (\< 20 years) or young adults (\< 30 years)
- histologically confirmed diagnosis of melanoma or intermediate/ambiguous melanocytic neoplasm (i.e., melanocytomas, SAMPUS, IAMPUS and MELTUMP according to WHO classification)
Who cannot join
- adult patients (\> 30 years of age)
- patients without histologically confirmed diagnosis of melanoma or intermediate/ambiguous melanocytic neoplasm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University of Florence
Florence, Italy, 50139
Daniela Massi Professor, 05579490982 ext. +39, daniela.massi@unifi.it
Dario Di Gangi Doctor, 3925536585 ext. +39, dario.digangi@unifi.it
About this study
Official title: Novel Health Care Strategies for Melanoma in Children, Adolescents, and Young Adults. Histological, Computational, and Molecular Pathology for Improved Diagnosis. (Mol-Mel). Work Package 3 (WP3)
The aim of this study is to investigate a type of skin cancer, also known as melanoma, in children, adolescents, and young adults, who will be referred to as CAYA patients in this project. The need for this study arises because this disease, in CAYA patients, is still poorly understood due to its rarity in individuals under 30 years old. This often leads to difficulties in assessing its severity and, consequently, in deciding on the necessary treatments to ensure the patient\&amp;#39;s recovery. The goal of this study is to examine melanoma in CAYA patients in order to gather the information needed to provide better diagnoses for affected patients and, as a result, select appropriate treatments to fight the disease and promote the patient\&amp;#39;s full recovery. Additionally, the data collected will be used to create a Pan-European online platform that will allow doctors across the European Union to consult the obtained data and collaborate on particularly complex melanoma cases, always with the aim of ensuring the patient\&amp;#39;s full recovery in the shortest possible time.
Read the detailed description
The Mol-Mel study will focus on different tasks and for each task different investigations will be carried out:
- Standardization and tissue quality control: The quality of the samples will then be determined using hematoxylin \&amp; eosin (HE)-staining. If any quality issue is detected feedback will be sent to the clinical center responsible for providing the sample
- Histopathology \&amp; computational pathology: Melanoma samples will undergo a central pathology review and analysis of conventional prognostic staging parameters. Diagnostically challenging neoplasms will be included in an "inter-observer agreement" carried out by different pathologist.Melanoma samples will also be charactered by single and multi-plex IHC in whole sections and tissue microarrays (TMA), and subjected to automated digital quantification. Spatial proteomics by automated ultra-high content imaging/MACSima Imaging Cyclic Staining (MICS) technology enables simultaneous analysis of hundreds of marker antigens on a single sample. Hundreds of antigens for single sample will be analysed via "Automated ultra-high content imaging/MACSima Imaging Cyclic Staining" (MICS) that will be performed on the novel automated ultra-high content imaging platform MACSimaTM (Miltenyi Biotec).
- Comprehensive somatic, transcriptional and DNA methylation landscape and data integration: DNA and RNA will be extracted by FFPE melanoma samples and characterized using whole-exome sequencing (WES), single nucleotide polymorphism (SNP) and RNA sequencing (RNAseq) arrays on matched tumor/normal pairs of samples. Then recurrent somatic aberrations, DNA methylation subclasses and patterns of tumor evolution will be characterized.
- Pan-European digital second opinion platform: this last task will focus on creating a pan-european second opinion platofrom in order to facilitate standardization of melanoma diagnosis and to share knowledge about biomarkers, algorithms and subtype classification.
- Conditions
- Melanoma of Skin
- Keywords
- Melanoma, Pediatric, Childrens, Adolescents, Young adults
- Medical subject headings
- 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 |
|---|---|---|
| CAYA Melanoma patients | Patients under 30 years of age at the moment of melanoma diagnosis. The patients have been divided in Children (1-14 yrs), Adolescents (15-18 yrs) and Young Adults (18-30 yrs) based on the age of diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective - Hybrid taxonomy
Integrate histopathology and molecular analyses to provide a novel hybrid taxonomy of melanoma in CAYA.
Measured: From enrollment at the end of 32 months
Primay objective - Histopathological and molecular features of pediatric melanoma
Assess the histopathological and molecular features of pediatric melanomas.
Measured: From enrollment at the end of 32 months
Secondary outcomes (3)
Secondary Objective - Identification of biomarkers
Identify prognostic biomarkers in the context of immunotherapy and targeted therapy.
Measured: From enrollment at the end of 32 months
Secondary Objective - pan-European digital pathology platform
Create a pan-European digital pathology platform to assess diagnostic inter-observer reproducibility, enhance international collaboration and achieve diagnosis standardization.
Measured: From enrollment at the end of 32 months
Secondary Objective - Identification of prognostic and predictive biomarkers
Identify driver mutations, transcriptomes, and DNA methylation subclasses with morphological, immunophenotypic analyses and clinical data to provide a novel hybrid taxonomy and identify tissue prognostic and predictive biomarkers.
Measured: From enrollment at the end of 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Apr 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Melanoma of SkinStudies 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Collaborators
- Tubingen University Hospital, Maria Sklodowska-Curie National Research Institute of Oncology, Fondazione IRCCS ISTITUTO NAZIONALE TUMORI, Hospital Clinic of Barcelona, Istanbul University, University Of Perugia, German Cancer Research Center
- Responsible party
- Principal investigator, Daniela Massi, University of Florence
- Investigators
- Massi Daniela, Principal investigator, University of Florence (UNIFI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602648
- Sponsor's protocol ID
- 24680_bio
- Acronym
- Mol-Mel
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Informations about the patients will be shared with other collaborators for the sharing of histological and clinical data in order to reach a consensus diagnosis between collaborating pathologists. Each collected sample will receive a identification code which will allow the results of the automated process to be saved and compared with those noted by the pathological anatomy medical staff. The code is assigned through pseudonymisation techniques (reversible de-identification), so that it cannot be directly traced back to the interested parties.
Publications
Pappo AS. Melanoma in children and adolescents. Eur J Cancer. 2003 Dec;39(18):2651-61. doi: 10.1016/j.ejca.2003.06.001.
PubMed 14642927Wiesner T, Kutzner H, Cerroni L, Mihm MC Jr, Busam KJ, Murali R. Genomic aberrations in spitzoid melanocytic tumours and their implications for diagnosis, prognosis and therapy. Pathology. 2016 Feb;48(2):113-31. doi: 10.1016/j.pathol.2015.12.007. Epub 2016 Jan 18.
PubMed 27020384Barnhill RL, Argenyi ZB, From L, Glass LF, Maize JC, Mihm MC Jr, Rabkin MS, Ronan SG, White WL, Piepkorn M. Atypical Spitz nevi/tumors: lack of consensus for diagnosis, discrimination from melanoma, and prediction of outcome. Hum Pathol. 1999 May;30(5):513-20. doi: 10.1016/s0046-8177(99)90193-4.
PubMed 10333219Cordoro KM, Gupta D, Frieden IJ, McCalmont T, Kashani-Sabet M. Pediatric melanoma: results of a large cohort study and proposal for modified ABCD detection criteria for children. J Am Acad Dermatol. 2013 Jun;68(6):913-25. doi: 10.1016/j.jaad.2012.12.953. Epub 2013 Feb 8.
PubMed 23395590de Vries M, Vonkeman WG, van Ginkel RJ, Hoekstra HJ. Morbidity after inguinal sentinel lymph node biopsy and completion lymph node dissection in patients with cutaneous melanoma. Eur J Surg Oncol. 2006 Sep;32(7):785-9. doi: 10.1016/j.ejso.2006.05.003. Epub 2006 Jun 27.
PubMed 16806794Ferrari A, Brecht IB, Gatta G, Schneider DT, Orbach D, Cecchetto G, Godzinski J, Reguerre Y, Bien E, Stachowicz-Stencel T, Ost M, Magni C, Kearns P, Vassal G, Massimino M, Biondi A, Bisogno G, Trama A. Defining and listing very rare cancers of paediatric age: consensus of the Joint Action on Rare Cancers in cooperation with the European Cooperative Study Group for Pediatric Rare Tumors. Eur J Cancer. 2019 Mar;110:120-126. doi: 10.1016/j.ejca.2018.12.031. Epub 2019 Feb 19.
PubMed 30785015Saiyed FK, Hamilton EC, Austin MT. Pediatric melanoma: incidence, treatment, and prognosis. Pediatric Health Med Ther. 2017 Apr 18;8:39-45. doi: 10.2147/PHMT.S115534. eCollection 2017.
PubMed 29388632Jen M, Murphy M, Grant-Kels JM. Childhood melanoma. Clin Dermatol. 2009 Nov-Dec;27(6):529-36. doi: 10.1016/j.clindermatol.2008.09.011.
PubMed 19880040
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Health Care Strategies for Melanoma in Children, Adolescents, and Young Adults. Histological, Computational, and Molecular Pathology for Improved Diagnosis. (Mol-Mel). Work Package 3 (WP3)
- ClinicalTrials.gov ID
- NCT06602648
- Acronym / sponsor ID
- Mol-Mel / 24680_bio
- Conditions
- Melanoma of Skin
- Keywords
- Melanoma, Pediatric, Childrens, Adolescents, Young adults
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Collaborators
- Tubingen University Hospital, Maria Sklodowska-Curie National Research Institute of Oncology, Fondazione IRCCS ISTITUTO NAZIONALE TUMORI, Hospital Clinic of Barcelona, Istanbul University, University Of Perugia, German Cancer Research Center
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
The aim of this study is to investigate a type of skin cancer, also known as melanoma, in children, adolescents, and young adults, who will be referred to as CAYA patients in this project. The need for this study arises because this disease, in CAYA patients, is still poorly understood due to its rarity in individuals under 30 years old. This often leads to difficulties in assessing its severity and, consequently, in deciding on the necessary treatments to ensure the patient\&amp;#39;s recovery. The goal of this study is to examine melanoma in CAYA patients in order to gather the information needed to provide better diagnoses for affected patients and, as a result, select appropriate treatments to fight the disease and promote the patient\&amp;#39;s full recovery. Additionally, the data collected will be used to create a Pan-European online platform that will allow doctors across the European Union to consult the obtained data and collaborate on particularly complex melanoma cases, always with the aim of ensuring the patient\&amp;#39;s full recovery in the shortest possible time.
Detailed description
The Mol-Mel study will focus on different tasks and for each task different investigations will be carried out:
- Standardization and tissue quality control: The quality of the samples will then be determined using hematoxylin \&amp; eosin (HE)-staining. If any quality issue is detected feedback will be sent to the clinical center responsible for providing the sample
- Histopathology \&amp; computational pathology: Melanoma samples will undergo a central pathology review and analysis of conventional prognostic staging parameters. Diagnostically challenging neoplasms will be included in an "inter-observer agreement" carried out by different pathologist.Melanoma samples will also be charactered by single and multi-plex IHC in whole sections and tissue microarrays (TMA), and subjected to automated digital quantification. Spatial proteomics by automated ultra-high content imaging/MACSima Imaging Cyclic Staining (MICS) technology enables simultaneous analysis of hundreds of marker antigens on a single sample. Hundreds of antigens for single sample will be analysed via "Automated ultra-high content imaging/MACSima Imaging Cyclic Staining" (MICS) that will be performed on the novel automated ultra-high content imaging platform MACSimaTM (Miltenyi Biotec).
- Comprehensive somatic, transcriptional and DNA methylation landscape and data integration: DNA and RNA will be extracted by FFPE melanoma samples and characterized using whole-exome sequencing (WES), single nucleotide polymorphism (SNP) and RNA sequencing (RNAseq) arrays on matched tumor/normal pairs of samples. Then recurrent somatic aberrations, DNA methylation subclasses and patterns of tumor evolution will be characterized.
- Pan-European digital second opinion platform: this last task will focus on creating a pan-european second opinion platofrom in order to facilitate standardization of melanoma diagnosis and to share knowledge about biomarkers, algorithms and subtype classification.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAYA Melanoma patients | – | –Patients under 30 years of age at the moment of melanoma diagnosis. The patients have been divided in Children (1-14 yrs), Adolescents (15-18 yrs) and Young Adults (18-30 yrs) based on the age of diagnosis. |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study will focus on CAYA (\< 30 y.o) patients with histologically confirmed melanoma or intermediate/ambiguous melanocytic neoplasm (i.e.,melanocytomas, SAMPUS, IAMPUS and MELTUMP according to WHO classification).The population include patients of both genders.
Key inclusion criteria (2 listed)
- adolescent and childhood patients (\< 20 years) or young adults (\< 30 years)
- histologically confirmed diagnosis of melanoma or intermediate/ambiguous melanocytic neoplasm (i.e., melanocytomas, SAMPUS, IAMPUS and MELTUMP according to WHO classification)
Key exclusion criteria (2 listed)
- adult patients (\> 30 years of age)
- patients without histologically confirmed diagnosis of melanoma or intermediate/ambiguous melanocytic neoplasm
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
Primary objective - Hybrid taxonomy
Time frame: From enrollment at the end of 32 months
Integrate histopathology and molecular analyses to provide a novel hybrid taxonomy of melanoma in CAYA.
Primay objective - Histopathological and molecular features of pediatric melanoma
Time frame: From enrollment at the end of 32 months
Assess the histopathological and molecular features of pediatric melanomas.
3 secondary outcomes
Secondary Objective - Identification of biomarkers
Time frame: From enrollment at the end of 32 months
Secondary Objective - pan-European digital pathology platform
Time frame: From enrollment at the end of 32 months
Secondary Objective - Identification of prognostic and predictive biomarkers
Time frame: From enrollment at the end of 32 months
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 19 Sep 2024.
- Background: PubMed 14642927Pappo AS. Melanoma in children and adolescents. Eur J Cancer. 2003 Dec;39(18):2651-61. doi: 10.1016/j.ejca.2003.06.001.
- Background: PubMed 27020384Wiesner T, Kutzner H, Cerroni L, Mihm MC Jr, Busam KJ, Murali R. Genomic aberrations in spitzoid melanocytic tumours and their implications for diagnosis, prognosis and therapy. Pathology. 2016 Feb;48(2):113-31. doi: 10.1016/j.pathol.2015.12.007. Epub 2016 Jan 18.
- Background: PubMed 10333219Barnhill RL, Argenyi ZB, From L, Glass LF, Maize JC, Mihm MC Jr, Rabkin MS, Ronan SG, White WL, Piepkorn M. Atypical Spitz nevi/tumors: lack of consensus for diagnosis, discrimination from melanoma, and prediction of outcome. Hum Pathol. 1999 May;30(5):513-20. doi: 10.1016/s0046-8177(99)90193-4.
- Background: PubMed 23395590Cordoro KM, Gupta D, Frieden IJ, McCalmont T, Kashani-Sabet M. Pediatric melanoma: results of a large cohort study and proposal for modified ABCD detection criteria for children. J Am Acad Dermatol. 2013 Jun;68(6):913-25. doi: 10.1016/j.jaad.2012.12.953. Epub 2013 Feb 8.
- Background: PubMed 16806794de Vries M, Vonkeman WG, van Ginkel RJ, Hoekstra HJ. Morbidity after inguinal sentinel lymph node biopsy and completion lymph node dissection in patients with cutaneous melanoma. Eur J Surg Oncol. 2006 Sep;32(7):785-9. doi: 10.1016/j.ejso.2006.05.003. Epub 2006 Jun 27.
- Background: PubMed 30785015Ferrari A, Brecht IB, Gatta G, Schneider DT, Orbach D, Cecchetto G, Godzinski J, Reguerre Y, Bien E, Stachowicz-Stencel T, Ost M, Magni C, Kearns P, Vassal G, Massimino M, Biondi A, Bisogno G, Trama A. Defining and listing very rare cancers of paediatric age: consensus of the Joint Action on Rare Cancers in cooperation with the European Cooperative Study Group for Pediatric Rare Tumors. Eur J Cancer. 2019 Mar;110:120-126. doi: 10.1016/j.ejca.2018.12.031. Epub 2019 Feb 19.
- Background: PubMed 29388632Saiyed FK, Hamilton EC, Austin MT. Pediatric melanoma: incidence, treatment, and prognosis. Pediatric Health Med Ther. 2017 Apr 18;8:39-45. doi: 10.2147/PHMT.S115534. eCollection 2017.
- Background: PubMed 19880040Jen M, Murphy M, Grant-Kels JM. Childhood melanoma. Clin Dermatol. 2009 Nov-Dec;27(6):529-36. doi: 10.1016/j.clindermatol.2008.09.011.
- MELCAYA official websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Informations about the patients will be shared with other collaborators for the sharing of histological and clinical data in order to reach a consensus diagnosis between collaborating pathologists. Each collected sample will receive a identification code which will allow the results of the automated process to be saved and compared with those noted by the pathological anatomy medical staff. The code is assigned through pseudonymisation techniques (reversible de-identification), so that it cannot be directly traced back to the interested parties.
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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.
Massi Daniela principal investigator
University of Florence (UNIFI)
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 of Skin, run by University of Florence at 1 site in Italy.
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 2 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 19 Sep 2024. 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 Italy. 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 Daniela Massi Professor (3925536585 ext. +39, daniela.massi@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective - Hybrid taxonomy (time frame: From enrollment at the end of 32 months). 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 NCT06602648, which also lists 8 linked publications.
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 19 Sep 2024.