MelanomaDISSEMELANCT02854124
Tracing Dissemination of Melanoma Cells in Healthy Tissues
An observational study of Melanoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The objective of this project is to evaluate the presence of melanoma quiescent or initiating clonal cells in peritumoral healthy tissue displaying the same molecular signature than those of the tumor/metastasis and to correlate this presence to the prognostic value. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Melanoma and peritumoral skin excision
- Type of treatment
- Surgery or procedure
- How many people
- 226 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2017to 12 Nov 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage Ib and II melanoma followed in the parisian cohort Melan-cohort, Cochin Hospital and Gustave Roussy Institute included between 2005 and 2009
Who may be able to join
- Men and women age > 18 years old.
- Primary melanomas stage Ib and II.
- Melanomas mutated BRAF, NRAS, c-kit.
- Cutaneous melanomas.
Who cannot join
- Metastatic melanomas stage III and IV.
- Melanomas with invasion of the peritumoral skin tissue.
- Congenital or acquired immunosuppression.
- Antitumoral, immunosuppressive treatments or any other diseases during the follow up.
Trial locations and contacts
1 site in 1 country.
France1 site
Name:: INSERM - UMRS 938, UPMC Saint-Antoinen Hospital, Team "Stem cells and transition from pre-invasive tumors"
Paris, Paris, 75012
About this study
Official title: Melanoma Cells Dissemination Study in Healthy Patients' Tissues
The objective of this project is to evaluate the presence of melanoma quiescent or initiating clonal cells in peritumoral healthy tissue displaying the same molecular signature than those of the tumor/metastasis and to correlate this presence to the prognostic value.
Read the detailed description
In the western world, melanoma incidence has constantly risen for the last 50 years, and it is currently reported as the most frequent tumor in 20 - 29 year old women. BRAF, NRAS and c-kit genes play an important role in cell proliferation and are mutated at very high frequency in melanoma. Despite the recent therapeutical breakthroughs obtained with the use of new drugs, metastatic melanoma remains still a life threatening disease. One of the main questions in melanoma concern the initial steps leading to metastatic spread, a better understanding being a key step to its prevention and the identification of new molecular mechanisms being implemental to the improvement of our therapeutical arsenal.
The proposed work aims to study the hypothesis of early spread in human melanoma using the recently developed powerful techniques of e-ice cold PCR, as well as classical immunohistochemistry. To do so, investigators will take advantage on the fact that treatment of melanoma relies on a secondary excision of normal peritumoral skin and sentinel lymph node. This peritumoral tissue is large (measuring 2 to 6 cm diameter), contains lymphatics in the hypodermis, the tissue considered to host the metastatic route of melanocytes and remains partially available for analysis.
All patients with stage Ib and II melanoma followed in the parisian cohort Melan-cohort, Cochin Hospital and Gustave Roussy Institute included between 2005 and 2009 will be found. A PCR analysis will be done on DNA extracted from paraffin embedded sections of primary tumors. Patients who display mutations in BRAF (BRAFV600E, BRAFV600K), NRAS (codon 61) or c-kit genes will be selected. The archival paraffin embedded tissues from healthy perilesional skin as well as from healthy sentinel lymph nodes will be obtained. Pyrosequencing and e-ice cold PCR targeting the mutations of the above genes at their usual positions will be done on DNA extracted from these specimens. Immunofluorescence anti-BRAFV600E or anti tumoral/initiating/stem cells will be done on same tissues. These simple techniques will test -using a sensitive molecular biology tool- whether in humans with melanomas, there is early dissemination of melanoma cells in histopathological healthy sentinel lymph node and peritumoral skin. The presence of these clonal cells in these healthy tissues will be correlated to the survival of the patients after 5 years and will allow the development of new therapeutic follow-up and strategies.
- Conditions
- Melanoma
- Being tested
- Melanoma and peritumoral skin excision
- Keywords
- Melanoma, Dissemination, Initiating stem cells
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melanoma and peritumoral skin excisionProcedure or surgery
Surgical retrieval of the primary tumor and safety retrieval of the surrounding normal peritumoral skin and sentinel lymph node
| Study group | Role | What they receive |
|---|---|---|
| Patients with stage Ib and II melanoma | Melanoma and peritumoral skin excision Receives: Procedure: Melanoma and peritumoral skin excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 5 years
correlation to the presence of tumoral initiating stem cells in healthy tissues
Measured: 5 years
Secondary outcomes (1)
Survival at 5 years without tumor recurrence
correlation to the presence of tumoral initiating stem cells in healthy tissues
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study start12 Oct 2017
- Primary completion12 Nov 2021
- Study completion12 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Retrospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Romain Fontaine, PhD, Principal investigator, INSERM - UMRS 938
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854124
- Sponsor's protocol ID
- NI15020
- Acronym
- DISSEMELA
- Status last verified
- Sep 2025
- First submitted
- 31 Jul 2016
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Curtin JA, Fridlyand J, Kageshita T, Patel HN, Busam KJ, Kutzner H, Cho KH, Aiba S, Brocker EB, LeBoit PE, Pinkel D, Bastian BC. Distinct sets of genetic alterations in melanoma. N Engl J Med. 2005 Nov 17;353(20):2135-47. doi: 10.1056/NEJMoa050092.
PubMed 16291983Faries MB, Steen S, Ye X, Sim M, Morton DL. Late recurrence in melanoma: clinical implications of lost dormancy. J Am Coll Surg. 2013 Jul;217(1):27-34; discussion 34-6. doi: 10.1016/j.jamcollsurg.2013.03.007. Epub 2013 May 3.
PubMed 23643694Quintana E, Shackleton M, Sabel MS, Fullen DR, Johnson TM, Morrison SJ. Efficient tumour formation by single human melanoma cells. Nature. 2008 Dec 4;456(7222):593-8. doi: 10.1038/nature07567.
PubMed 19052619How-Kit A, Tost J. Pyrosequencing(R)-Based Identification of Low-Frequency Mutations Enriched Through Enhanced-ice-COLD-PCR. Methods Mol Biol. 2015;1315:83-101. doi: 10.1007/978-1-4939-2715-9_7.
PubMed 26103893
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melanoma Cells Dissemination Study in Healthy Patients' Tissues
- ClinicalTrials.gov ID
- NCT02854124
- Acronym / sponsor ID
- DISSEMELA / NI15020
- Conditions
- Melanoma
- Keywords
- Melanoma, Dissemination, Initiating stem cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 3 Aug 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.
The objective of this project is to evaluate the presence of melanoma quiescent or initiating clonal cells in peritumoral healthy tissue displaying the same molecular signature than those of the tumor/metastasis and to correlate this presence to the prognostic value.
Detailed description
In the western world, melanoma incidence has constantly risen for the last 50 years, and it is currently reported as the most frequent tumor in 20 - 29 year old women. BRAF, NRAS and c-kit genes play an important role in cell proliferation and are mutated at very high frequency in melanoma. Despite the recent therapeutical breakthroughs obtained with the use of new drugs, metastatic melanoma remains still a life threatening disease. One of the main questions in melanoma concern the initial steps leading to metastatic spread, a better understanding being a key step to its prevention and the identification of new molecular mechanisms being implemental to the improvement of our therapeutical arsenal.
The proposed work aims to study the hypothesis of early spread in human melanoma using the recently developed powerful techniques of e-ice cold PCR, as well as classical immunohistochemistry. To do so, investigators will take advantage on the fact that treatment of melanoma relies on a secondary excision of normal peritumoral skin and sentinel lymph node. This peritumoral tissue is large (measuring 2 to 6 cm diameter), contains lymphatics in the hypodermis, the tissue considered to host the metastatic route of melanocytes and remains partially available for analysis.
All patients with stage Ib and II melanoma followed in the parisian cohort Melan-cohort, Cochin Hospital and Gustave Roussy Institute included between 2005 and 2009 will be found. A PCR analysis will be done on DNA extracted from paraffin embedded sections of primary tumors. Patients who display mutations in BRAF (BRAFV600E, BRAFV600K), NRAS (codon 61) or c-kit genes will be selected. The archival paraffin embedded tissues from healthy perilesional skin as well as from healthy sentinel lymph nodes will be obtained. Pyrosequencing and e-ice cold PCR targeting the mutations of the above genes at their usual positions will be done on DNA extracted from these specimens. Immunofluorescence anti-BRAFV600E or anti tumoral/initiating/stem cells will be done on same tissues. These simple techniques will test -using a sensitive molecular biology tool- whether in humans with melanomas, there is early dissemination of melanoma cells in histopathological healthy sentinel lymph node and peritumoral skin. The presence of these clonal cells in these healthy tissues will be correlated to the survival of the patients after 5 years and will allow the development of new therapeutic follow-up and strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with stage Ib and II melanoma | – | Procedure: Melanoma and peritumoral skin excisionMelanoma and peritumoral skin excision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage Ib and II melanoma followed in the parisian cohort Melan-cohort, Cochin Hospital and Gustave Roussy Institute included between 2005 and 2009
Key inclusion criteria (4 listed)
- Men and women age > 18 years old.
- Primary melanomas stage Ib and II.
- Melanomas mutated BRAF, NRAS, c-kit.
- Cutaneous melanomas.
Key exclusion criteria (4 listed)
- Metastatic melanomas stage III and IV.
- Melanomas with invasion of the peritumoral skin tissue.
- Congenital or acquired immunosuppression.
- Antitumoral, immunosuppressive treatments or any other diseases during the follow up.
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 |
|---|---|---|
| Melanoma and peritumoral skin excisionSurgical retrieval of the primary tumor and safety retrieval of the surrounding normal peritumoral skin and sentinel lymph node | Procedure or surgery | Patients with stage Ib and II melanoma |
Primary outcome
Survival at 5 years
Time frame: 5 years
correlation to the presence of tumoral initiating stem cells in healthy tissues
1 secondary outcome
Survival at 5 years without tumor recurrence
Time frame: 5 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 20 Nov 2025.
- Background: PubMed 16291983Curtin JA, Fridlyand J, Kageshita T, Patel HN, Busam KJ, Kutzner H, Cho KH, Aiba S, Brocker EB, LeBoit PE, Pinkel D, Bastian BC. Distinct sets of genetic alterations in melanoma. N Engl J Med. 2005 Nov 17;353(20):2135-47. doi: 10.1056/NEJMoa050092.
- Background: PubMed 23643694Faries MB, Steen S, Ye X, Sim M, Morton DL. Late recurrence in melanoma: clinical implications of lost dormancy. J Am Coll Surg. 2013 Jul;217(1):27-34; discussion 34-6. doi: 10.1016/j.jamcollsurg.2013.03.007. Epub 2013 May 3.
- Background: PubMed 19052619Quintana E, Shackleton M, Sabel MS, Fullen DR, Johnson TM, Morrison SJ. Efficient tumour formation by single human melanoma cells. Nature. 2008 Dec 4;456(7222):593-8. doi: 10.1038/nature07567.
- Background: PubMed 26103893How-Kit A, Tost J. Pyrosequencing(R)-Based Identification of Low-Frequency Mutations Enriched Through Enhanced-ice-COLD-PCR. Methods Mol Biol. 2015;1315:83-101. doi: 10.1007/978-1-4939-2715-9_7.
- Individual participant dataSharing planned: No
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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.
Romain Fontaine, PhD principal investigator
INSERM - UMRS 938
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 Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 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 20 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 France. 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?
Survival at 5 years (time frame: 5 years). 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 NCT02854124, which also lists 4 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 20 Nov 2025.