Evaluation of safety and usefulness of sentinel node biopsy in the patients with malignant melanoma

Evaluation of safety and usefulness of sentinel node biopsy in the patients with malignant melanoma - Sentinel node biopsy in melanoma

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001162

Enrollment

200

Registered

2008-05-20

Start date

2008-05-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Malignant melanoma

Interventions

Patients undergo cutaneous lymphoscintigraphy with radiopharmaceuticals, either one day before or on the day of the operative procedure. Using the lymphoscintigraphic images, the skin site correspondi

E). If metastases are not detected by H&amp

E staining of the first section, then additional sections are cut from the bivalved lymph nodes and stained with the murine monoclonal antibodies Mart1 (MelanA), HMB-45 and S-100 for immunohistochemic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with a primary cutaneous melanoma without any clinical evidence of metastatic disease and with the primary lesion 1mm or more in thickness or with Clark's levels IV and V, or the primary lesion with ulceration irrespective of the thickness.

Exclusion criteria

Exclusion criteria: Patients with distant metastasis. Patients with severe liver dysfunction. Pregnant, possible pregnant or feeding women. Patients without informed consent. Patients regarded as not adequate for this study by physicians.

Design outcomes

Primary

Measure	Time frame
Safety of sentinel node biopsy	—

Secondary

Measure	Time frame
Efficacy	—

Countries

Japan

Contacts

Public ContactHisashi Uhara

School of Medicine, Shinsu University Department of Dermatology

0263-37-2647

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026