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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05079113

Enrollment

Registered

2021-10-15

Start date

2019-10-01

Completion date

2023-04-04

Last updated

2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage III Melanoma, Stage IV Cutaneous Melanoma

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results