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

Stage III Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05079113
• Other study ID #: CASE1619
• Status: Active, not recruiting
• Start date: October 1, 2019
• Est. completion date: April 2025

Study information

• Verified date: November 2023
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 73
• Est. completion date: April 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Recurrence
• Stage III Melanoma
• Stage IV Cutaneous Melanoma

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify a pattern for gene recognition of cancer recurrence earlier than standard of care.	Genomic sequencing of 40+ ctDNA genes will be analyzed to identify genetic alterations correlating with the development of recurrence in melanoma.	samples taken at baseline, 3 months, 6 months and 18 months.
Secondary	Analyze the genetic pathway associated with cancer recurrence and biologic information.	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.	samples taken at baseline, 3 months, 6 months and 18 months.