51 Participants NeededMy employer runs this trial

Risk-Based Surgery Guidance for Skin Cancer in Children

Recruiting at 12 trial locations
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Children's Oncology Group
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve surgical treatment for children with specific skin tumors, such as localized melanoma or atypical Spitz tumors. It compares a new approach, called risk-based guided surgical management, which uses risk levels to determine how much skin to remove during surgery, against the usual method. By tailoring surgery based on risk, the trial seeks to prevent unnecessary procedures and enhance recovery. Children up to 25 years old with newly diagnosed skin tumors that haven't spread are suitable candidates for this study. As an unphased trial, this study provides participants the opportunity to contribute to innovative surgical methods that could improve outcomes for future patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does state that you must not have received any prior chemotherapy, immunotherapy, targeted therapy, radiation, or surgical therapy for melanoma other than the permitted biopsy/excision.

What prior data suggests that this risk-based surgical management is safe for children with skin cancer?

Research shows that wide local excision (WLE) is a common and generally safe treatment for melanoma. Studies have found that most people tolerate WLE well, though risks include infection, scarring, bleeding, and healing problems. Many patients recover well from these procedures without major issues. While minor side effects may occur, this procedure remains a standard choice for treating melanoma and has been used successfully in many cases.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring innovative surgical approaches for treating skin cancer in children. Instead of the usual one-size-fits-all wide local excision, this trial investigates a risk-based guided surgical management approach. This means surgeries are tailored based on individual risk assessments, potentially leading to less invasive procedures for some patients. By customizing the surgical strategy, there's hope for fewer complications and a better quality of life for young patients, while still effectively managing their cancer.

What evidence suggests that this trial's treatments could be effective for localized skin cancer in children?

Research has shown that wide local excision surgery, a treatment in this trial, effectively treats melanoma by removing cancerous tissue and reducing the chance of recurrence. Studies indicate a cure rate of about 95% for nonmelanoma skin cancers using this method. In children, prompt treatment of melanoma is crucial, as it poses the greatest danger among skin cancers. Another approach in this trial, risk-based surgical management, customizes surgery based on the tumor's risk level. This method can improve outcomes by avoiding unnecessary procedures and focusing on precise treatment. By classifying tumors and adjusting the surgical approach, it may effectively manage localized skin cancer in children.26789

Who Is on the Research Team?

BK

Brittani K Seynnaeve

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

This trial is for children and young adults (25 or younger) with newly diagnosed skin melanoma, atypical Spitz/Spitzoid tumors, or similar unusual moles that have not spread beyond the skin. Participants must be in generally good health and cannot have had prior cancer treatments except for a biopsy of the current lesion.

Inclusion Criteria

I am 25 years old or younger.
I have a new diagnosis of localized melanoma or an atypical melanocytic tumor.
My disease is only present on my skin.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients are assigned to different treatment arms based on tumor risk classification, including observation, narrow margin re-excision, or wide local excision with or without sentinel lymph node biopsy.

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits every 3-6 months for the first 2 years, then every 6 months up to 5 years.

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Re-Excision
  • Risk-based guided surgical management
  • Sentinel Lymph Node Biopsy
  • Wide Local Excision

Trial Overview

The study compares using genetic and pathology information to guide surgery versus standard care in treating localized melanoma or similar skin tumors. Based on risk, patients may get no further surgery, minor removal around the tumor, or more extensive surgery possibly with lymph node biopsy.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Arm B (wide local excision, SLNB)Experimental Treatment9 Interventions
Group II: Treatment Arm A (narrow margin)Experimental Treatment1 Intervention
Group III: Observation Arm (observation)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials
467
Recruited
241,000+

Citations

Surgical Outcomes of Nonmelanoma Skin Cancer ...

Results: Among 47 tumors treated with WLE, positive margins occurred in 10.6%. Among 24 MMS cases, 70.8% were cleared in a single stage. Local recurrence ...

Wide-local Excision

Wide-local excision often is used for BCC and SCC on lower risk body sites. If caught early, the procedure can cure melanoma. offers results that are both ...

Pediatric melanoma: incidence, treatment, and prognosis - PMC

The purpose of this review is to outline recent advancements in diagnosis, treatment, and prevention of pediatric melanoma.

Wide Local Excision Surgery Treatment for Melanoma - MRA

Wide local excisions can increase your risk of infection, cause scarring at the surgical site, bleeding, and healing problems may occur.

Treatment of Pediatric Melanoma | SCF

Melanoma in childhood has gained attention as the deadliest form of pediatric skin cancer. Most pediatricians now realize the importance of prompt evaluation ...

Melanoma | Pediatric Surgery NaT

For in situ lesions, 0.5-1.0 cm margins for wide local excision are recommended. wide local excision for melanoma is one of those procedure.

Educational Literature & Materials

Doctors treat stage 1 melanoma with surgery to remove the cancer. Usually this is a procedure called a wide local excision. This is when a larger oval-shaped ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39349345/

The Impact of Surgical Margin in Wide Local Excision of ...

Conclusion: Pediatric head/neck melanomas undergoing WLE were likelier to have narrow margins <2 cm and less likely to meet NCCN criteria. Narrow margins may ...

Pediatric Plantar Malignant Melanoma, Subungual ...

Pediatric melanoma, while exceedingly rare, is the most commonly diagnosed skin cancer in children, with an average of 300 to 500 new diagnoses annually.