Prospective Dutch cohort study of a primary melanoma gene-signature (CP-GEP model) to predict sentinel node status

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24310

Enrollment

300

Registered

2020-07-09

Start date

2020-07-12

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Melanoma (cutaneous)

Interventions

None

Eligibility

Inclusion criteria

Inclusion criteria: • Newly diagnosed melanoma of the skin after central pathology review. • Male or female, age =18 years. • Elected to undergo sentinel lymph node biopsy (pT1b – pT4) per the national Dutch guideline by the NVvH (Dutch Society of Surgery) published October 2019

Exclusion criteria

Exclusion criteria: • Documented clinically positive nodes (N+) at diagnosis. • Satellite or in-transit metastases. • Multiple primary invasive melanoma mapping to the same draining lymph node basin. • Distant metastatic disease (M1a,b,c) clinically present at primary diagnosis • Documented prior history of a primary invasive melanoma of T1b or greater within the last 5 years. • Ocular and mucosal melanomas and melanocytic tumors of uncertain malignant potential (MELTUMP) or (atypical) Spitz tumors. • Full primary melanoma pathology report and diagnostic paraffin-embedded biopsy tissue unavailable.

Design outcomes

Primary

Measure	Time frame
CP-GEP test outcome (Note: as this is an implementation study, only descriptive data will be rendered)	—

Secondary

Measure	Time frame
Evaluation of subsequent care and health status	—

Contacts

Public ContactEvalyn Mulder

Erasmus MC Cancer Institute

e.e.a.p.mulder@erasmusmc.nl010-7042125

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)