UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042040 |
|---|---|
| Receipt number | R000047978 |
| Scientific Title | Integrated genomic and epigenomic analysis of circulating tumor DNA from patients with malignant melanoma |
| Date of disclosure of the study information | 2020/10/07 |
| Last modified on | 2023/04/10 09:07:58 |
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Basic information
Public title
Integrated genomic and epigenomic analysis of circulating tumor DNA from patients with malignant melanoma
Acronym
COSMOS-MEL-01
Scientific Title
Integrated genomic and epigenomic analysis of circulating tumor DNA from patients with malignant melanoma
Scientific Title:Acronym
COSMOS-MEL-01
Region
| Japan |
Condition
Condition
malignant melanoma
Classification by specialty
| Hematology and clinical oncology | Dermatology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Positive rate of LUNAR assay in malignant melanoma
Basic objectives2
Others
Basic objectives -Others
*Positive rates of LUNAR assays in each subgroup
*Association between postoperative LUNAR assay positivity and prognosis
*Agreement between LUNAR assays and genomic abnormalities in tumor tissues
*Positive rate of LUNAR assay at relapse
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive rate of LUNAR assay in malignant melanoma
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Nakamura |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology and Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
yoshinak@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Kenjiro |
| Middle name | |
| Last name | Namikawa |
Organization
National Cancer Center Hospital
Division name
Department of Dermatologic Oncology
Zip code
104-0045
Address
5-1-1,Tsukiji, Chuo-Ku, Tokyo,
TEL
03-3542-2511
Homepage URL
knamikaw@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
*Department for the Promotion of Drug and Diagnostic Development,Translational Research Support Office
*Guardant Health, Inc
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1, Tsukiji, Chuo ku, Tokyo, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 10 | Month | 07 | Day |
Last modified on
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047978
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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