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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2023-04-04

Brief Summary

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

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Detailed Description

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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.

Conditions

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Stage III Melanoma Stage IV Cutaneous Melanoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

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