malignant melanoma
Conditions
Interventions
None listed
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age at least 18 years old on the date of obtaining consent 2. Pathologically confirmed diagnosis of any of the following a through e a. Pathological stage IIB primary melanoma of the skin b. Pathological stage IIC primary melanoma of the skin c. Pathological stage III primary melanoma of the skin d. Invasive mucosal melanoma e. Melanoma of unknown primary 3. Positive BRAF V600-mutation status detected by the approved diagnostics in Japan 4. All known lesions have been surgically resected and the patient has the conditions of the following a through c if applicable. a. Primary melanoma has been completely resected. b. Clinically detected regional lymph node metastases have been resected by completion lymph node dissection. c. In-transit metastases have been completely resected. 5. No more than 8 weeks between final surgical resection and enrollment, and no more than 4 weeks between enrollment and scheduled adjuvant therapy initiation 6. No prior history of anti-cancer systemic therapy for melanoma of the inclusion criteria No.2 7. No distant metastasis on CT scan of the head, neck, thorax, abdomen, and pelvis within 84 days before enrollment *1*2 8. ECOG performance status 0 or 1 9. Adjuvant therapy with nivolumab, pembrolizumab, or dabrafenib/trametinib is scheduled. 10. Willing to submit blood and tissue samples in accordance with the research protocol 11. Written informed consent *1 Subjects with allergies/sensitivities to contrast media, etc. may be performed without contrast media. *2 Contrast brain CT can be replaced with brain MRI.
Exclusion criteria
Exclusion criteria: 1. A history of active malignancy within 5 years of disease-free status. However, patients with basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, cervical cancer, endoscopically curable carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma equivalent lesions, or non-metastatic prostate cancer that does not require systemic treatment, who are judged to be cured by local treatment, will be enrolled in the registry if they are disease-free for 5 years or less It shall be possible. 2. Duplicate cancers are suspected on the head, neck, thorax, abdomen, and pelvic contrast CT scan within 84 days before enrollment *1*2. 3. Women who are pregnant or breastfeeding 4. Attending physician determines that the subject is unsuitable for enrollment in this study. *1 Subjects with allergies/sensitivities to contrast media, etc. may be performed without contrast media. *2 Contrast brain CT can be replaced with brain MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive rate of Guardant Reveal assay before/during/after adjuvant therapy and its correlation with prognosis | — |
Countries
Japan
Contacts
Public ContactKenjiro Namikawa
National Cancer Center Hospital Department of Dermatologic Oncology
Outcome results
None listed