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Integrated genomic and epigenomic analysis of circulating tumor DNA from patients with malignant melanoma

Integrated genomic and epigenomic analysis of circulating tumor DNA from patients with malignant melanoma - COSMOS-MEL-01

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000042040
Enrollment
50
Registered
2020-10-07
Start date
2021-07-05
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

None listed

Sponsors

National Cancer Center Hospital East
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Age at least 20 years old on the date of obtaining consent. 2.Suspected malignant melanoma on clinical and dermoscopy findings, or histopathologically diagnosed malignant melanoma on biopsy. 3.Diagnosed as radically resectable on a CT scan of the head, neck, thorax and abdomen and pelvis within 60 days prior to enrollment.* 4.The patient has been diagnosed with any of the following a. through e. as clinical stage. a.Invasive mucosal malignant melanoma*2 b.Clinical stage IIB Primary malignant melanoma of the skin, malignant melanoma of the uvea. c.Clinical stage IIC Primary malignant melanoma of the skin, malignant melanoma of the uvea. d.Clinical stage III Primary malignant melanoma of the skin, malignant melanoma of the uvea. e.Primary malignant melanoma of the skin with clinical and dermoscopic findings of a primary tumor thickness greater than 2.0 mm with ulceration or expected to be greater than 4.0 mm. 5.No prior history of curative surgery, cancer drug therapy, or radiation therapy for curative purposes prior to enrollment in eligibility criteria 2. to 4. for malignant melanoma, and curative surgery is scheduled after enrollment. 6.Willing to submit blood and tissue samples in accordance with the research protocol. 7.Consent has been obtained in writing. *1 Subjects with allergies/sensitivities to contrast media, etc. may be performed without contrast media. *2 Invasive mucosal malignant melanoma includes the head and neck, conjunctiva, upper/lower gastrointestinal tract, and vulva/vaginal primary

Exclusion criteria

Exclusion criteria: 1.A history of active malignancy within 5 years of disease-free status. However, patients with basal cell carcinoma or spinous 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 head, neck, thorax and abdomen and pelvic contrast CT scan within 60 days prior to enrollment. 3.Women who are pregnant. 4.Your physician determines that you are unsuitable for enrollment in this study.

Design outcomes

Primary

MeasureTime frame
Positive rate of LUNAR assay in malignant melanoma

Countries

Japan

Contacts

Public ContactKenjiro Namikawa

National Cancer Center Hospital Department of Dermatologic Oncology

knamikaw@ncc.go.jp03-3542-2511

Outcome results

None listed

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