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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00009507

Enrollment

Registered

2016-04-04

Start date

2015-09-11

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

C43.0

Interventions

Group 1: 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 resect

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Germany

Contacts

Public ContactNikolas von Bubnoff

Universitätsklinikum Freiburg

nikolas.bubnoff@uniklinik-freiburg.de+49 761 270 37850

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026