Malignant melanoma Malignant melanoma
Conditions
Interventions
Measurement of equivalent thermal conductivity by non-approved equipment
Engeneering
Sponsors
Fujimura Taku
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients for whom free and voluntary written consent to participate in this clinical trial has been obtained from the patient or the patient's surrogate. (2) Male and female patients who are at least 18 years of age at the time of consent. (3) Patients who are suspected of having malignant melanoma based on clinical and dermoscopic findings and who are deemed by a dermatologist to require a partial biopsy. (4) Patients who have a healthy area of skin outside the grossly visible border of the suspected malignant melanoma that is comparable to the area of the suspected malignant melanoma. (5) Patients who agree to undergo biopsy or extended resection of the primary tumor for malignant melanoma. (6) Patient agrees to have photographs taken of the measurement site with the test device.
Exclusion criteria
Exclusion criteria: (1) Patients with skin surface lesions in the area of suspected malignant melanoma, such as ulcers. (2) Patients whom a dermatologist determines to have mucosal melanoma based on the site of origin. (3) Patients in whom the dermatologist suspects malignant melanoma of unknown primary based on clinical findings. (4) Patients whose systemic condition is determined by the investigator or sub-investigator to be unsuitable for biopsy or extended primary resection of malignant melanoma. (5) Pregnant patients (6) Patients who are enrolled or will be enrolled in another clinical trial or interventional clinical trial during the course of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy endpoints: (1) Sensitivity and specificity (presence/absence of invasion, benign/malignant, good/malignant) of the device for the determination of benign tumor, intraepidermal malignancy, and dermal invasion malignancy of the target lesion when the pathological diagnosis (presence of dermal invasion confirmed at primary tumor resection, good/malignant diagnosed on partial biopsy) is the correct label.) (2) Sensitivity and specificity (with/without invasion) for the presence or absence of sentinel lymph node biopsy when the pathologic diagnosis of the target lesion (presence or absence of dermal invasion confirmed at the time of primary tumor resection, good/malignant diagnosed by partial biopsy) is the correct label. Safety endpoints: (1) Adverse events: Pain and other assessments, inflammatory findings, other adverse events (2) Investigational device failure | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory endpoints: (1) Investigation of cut-off values to discriminate benign tumors/intraepidermal malignancies/dermal invasive malignancies of the test device. (2) Investigation of usability of the device. | — |
Contacts
Public ContactClinical Trial Coordinating Office
Clinical Research, Innovation and Education Center, Tohoku University Hospital
Outcome results
None listed