Pilot study to evaluate the feasibility and prognostic significance of detection of mutated, free circulating tumor DNA in plasma of patients with melanoma

Recruiting

• Conditions: C43.0; Malignant melanoma of lip

• Registration Number: DRKS00009507
• Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Histologically confirmed melanoma
2. Locally advanced (stage III) or metastatic (stage IV) disease
3. Primary diagnosis or relapse or progression
4. Planned resection of one or more disease manifestations or planned systemic treatment
5. Known activating mutation of BRAF or NRAS or mutation status unknown and tissue sample can be provided for mutation analysis at screening
6. At least one melanoma lesion that can be measured by CT, PET-CT, or MRI (stage IV only)
7. Routinely planned follow-up visits at intervals of no longer than three months including S100, LDH and local standard of care diagnostic imaging

Exclusion Criteria

1. Uveal melanoma
2. Surgery of primary or progressive lesions already completed and currently no evidence of progressive lesions
3. Wild-type sequence of tissue specimen for BRAF and NRAS genes
4. More than one line of previous systemic treatment (stage IV only)
5. Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix and basal or squamous cell carcinoma of the skin

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In this collaborative scientific project, we wish to examine whether in melanoma, circulating tumor (ct)DNA harboring tumor-specific mutations can be detected in serum of patients with resectable, locally advanced (stage III) and metastatic (stage IV) melanoma. We will investigate whether the amount of mutant ctDNA is informative with respect to clinical endpoints such as response to treatment, the probability of relapse, progression-free and overall survival.

Secondary Outcome Measures

Name	Time	Method
In addition, we wish to query whether evolution of clonal heterogeneity can be demonstrated in ctDNA, and whether clonal heterogeneity in ctDNA is predictive for progression-free and overall survival.