FindMyKOL
Clinical trialNCT07621614RecruitingPhase 2Interventional

A Study on How to Safely Guide Surgery for Melanoma and Similar Skin Tumors in Children Using Pathology and Genetic Information

SponsorChildren's Oncology GroupEnrollment51Clinical Stage 0 Cutaneous Melanoma AJCC v8Clinical Stage I Cutaneous Melanoma AJCC v8Clinical Stage II Cutaneous Melanoma AJCC v8Cutaneous Melanocytic NeoplasmCutaneous MelanomaCutaneous Spitz Melanocytoma+1 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase II trial compares the effect of using risk-based stratification to guide surgical management to the usual approach in treating cutaneous melanoma, atypical Spitz/Spitzoid tumors or other atypical melanocytic tumors that have not spread to other parts of the body (localized). Melanoma is a cancer that in children is sometimes difficult to tell apart from benign (not harmful) or atypical (uncertain if harmful) skin lesions. Failure to diagnose melanoma can result in inadequate surgical removal and increase the risk of recurrence and metastatic disease (spread from where it first started to other places in the body). In addition, diagnosing a tumor a benign (not cancer) tumor as cancer may lead to unnecessary surgery and treatment. This trial reviews tumor pathology and genetic markers and classifies the tumor as not atypical, atypical but low risk for spread and/or recurrence (coming back after a period of improvement), and atypical and high risk for spread and/or recurrence. The classifications are then used to provide surgical recommendations. Tumors that are not atypical do not receive any surgical treatment. Low-risk recommendations include removing a small layer of normal skin around the tumor. High-risk recommendations include the usual adult melanoma approach of removing a larger layer of normal skin around the tumor with or without a biopsy of the sentinel lymph node (the first lymph node to which tumor cells are likely to spread from a primary tumor). Risk-based guided surgical management may help avoid unnecessary surgery while improving outcomes in younger patients with localized cutaneous melanoma, atypical Spitz/Spitzoid tumors or other atypical melanocytic tumors.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

13 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Kaiser Permanente-Oakland

    Oakland, California, United States

    Aarati V. Rao
    Recruiting
  • Alfred I Dupont Hospital for Children

    Wilmington, Delaware, United States

    Sridhi Patel
    Recruiting
  • Nemours Children'S Clinic-Jacksonville

    Jacksonville, Florida, United States

    Sridhi Patel
    Recruiting
  • Nemours Children'S Hospital

    Orlando, Florida, United States

    Sridhi Patel
    Recruiting
  • Nemours Children'S Clinic - Pensacola

    Pensacola, Florida, United States

    Jeffrey H. Schwartz
    Recruiting
  • Promedica Toledo Hospital/russell J Ebeid Children'S Hospital

    Toledo, Ohio, United States

    Jamie L. Dargart
    Recruiting
  • Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

    Theodore W. Laetsch
    Recruiting
  • Children'S Hospital of Pittsburgh of Upmc

    Pittsburgh, Pennsylvania, United States

    Brittani K. Seynnaeve
    Recruiting
  • East Tennessee Childrens Hospital

    Knoxville, Tennessee, United States

    Susan E. Spiller
    Recruiting
  • Saint Jude Children'S Research Hospital

    Memphis, Tennessee, United States

    Alberto S. Pappo
    Recruiting
  • Dell Children'S Medical Center of Central Texas

    Austin, Texas, United States

    Shannon M. Cohn
    Recruiting
  • Ut Md Anderson Cancer Center

    Houston, Texas, United States

    Recruiting
  • Primary Children'S Hospital

    Salt Lake City, Utah, United States

    Casey J. Mehrhoff
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
15 May 2027
Primary completion
31 Jul 2028
Completion
31 Jul 2028
Last update posted
24 Sept 2026
Registered enrollment
51
Registry id
NCT07621614

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.