Clinical trial · Observational
Tracing Dissemination of Melanoma Cells in Healthy Tissues
Melanoma Cells Dissemination Study in Healthy Patients' Tissues
NCT02854124CI-TRIAL-00097650DISSEMELAcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Melanoma and peritumoral skin excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with stage Ib and II melanoma
- description
- Melanoma and peritumoral skin excision
- interventionNames
- Procedure: Melanoma and peritumoral skin excision
Primary outcomes (1)
- measure
- Survival at 5 years
- timeFrame
- 5 years
- description
- correlation to the presence of tumoral initiating stem cells in healthy tissues
Secondary outcomes (1)
- measure
- Survival at 5 years without tumor recurrence
- timeFrame
- 5 years
- description
- correlation to the presence of tumoral initiating stem cells in healthy tissues
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women age \> 18 years old. * Primary melanomas stage Ib and II. * Melanomas mutated BRAF, NRAS, c-kit. * Cutaneous melanomas. Exclusion Criteria: * 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.
References
Publications (4)
- BACKGROUNDCurtin 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. PMID 16291983
- BACKGROUNDFaries 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. PMID 23643694
- BACKGROUNDQuintana 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. PMID 19052619
- BACKGROUNDHow-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. PMID 26103893