Leveraging ctDNA Analysis to Improve Early Detection of Cancer Recurrence in the High-Risk Melanoma Setting

Completed

• Conditions: Stage III Melanoma; Stage IV Cutaneous Melanoma

• Registration Number: NCT05079113
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

To generate meaningful data regarding ctDNA that would infer risk of recurrence in stage III melanoma patients.

Detailed Description

Cancer cells harbor and can acquire potentially hundreds of mutations, many of whom are found in the ctDNA. Circulating tumor DNA (ctDNA) holds the promise for the 50% of participants who do not need adjuvant therapies - participants could be monitored to ensure no increase in ctDNA. Participants treated could then be followed for the earliest possible blood level signs of recurrence (incr. ctDNA) and more quickly be switched to more effective therapies. Further, the treating physician could hold therapy until the first signs of ctDNA based recurrence for those participants that would benefit.

Blood sample from a biobank will be used to identify to monitor ctDNA. These blood samples were drawn at baseline, 3 months, 6 months and 18 months.

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-15
• Primary Completion: 2023-04-04
• Study Completion: 2023-04-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Age ≥18
• Confirmed fully resected Stage IIIb-IV cutaneous melanoma; including patients treated neoadjuvantly within three months prior to resection.

Exclusion Criteria

• Treatment plan inconsistent with the standard of care systemic adjuvant therapies 4.0 Study Design

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify a pattern for gene recognition of cancer recurrence earlier than standard of care.	samples taken at baseline, 3 months, 6 months and 18 months.	Genomic sequencing of 40+ ctDNA genes will be analyzed to identify genetic alterations correlating with the development of recurrence in melanoma.

Secondary Outcome Measures

Name	Time	Method
Analyze the genetic pathway associated with cancer recurrence and biologic information.	samples taken at baseline, 3 months, 6 months and 18 months.	The sequencing data will be analyzed against established determinants of cancer biology in clinically relevant melanoma variants identified via analysis of The Cancer Genome Atlas database.

Trial Locations

Locations (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer center; 🇺🇸 Cleveland, Ohio, United States