UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051210 |
|---|---|
| Receipt number | R000058142 |
| Scientific Title | Integrated genomic and epigenomic analysis of circulating tumor DNA from patients with BRAF V600-mutant melanoma |
| Date of disclosure of the study information | 2023/07/20 |
| Last modified on | 2023/08/21 11:47:16 |
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Basic information
Public title
Integrated genomic and epigenomic analysis of circulating tumor DNA from patients with BRAF V600-mutant melanoma
Acronym
COSMOS-MEL-02
Scientific Title
Integrated genomic and epigenomic analysis of circulating tumor DNA from patients with BRAF V600-mutant melanoma
Scientific Title:Acronym
COSMOS-MEL-02
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 Guardant Reveal assay before/during/after adjuvant therapy and its correlation with prognosis
Basic objectives2
Others
Basic objectives -Others
Positive rate of Guardant Reveal assay according to each melanoma subtype and pathological stage
Overall positive rate of Guardant Reveal assay in BRAF V600-mutant melanoma
Concordance of genomic alterations between liquid- and tissue-based assay
Positive rate of Guardant Reveal assay at disease recurrence
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive rate of Guardant Reveal assay before/during/after adjuvant therapy and its correlation with prognosis
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
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
Guardant Health, Inc
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
USA
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
| 2023 | Year | 07 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2023 | Year | 05 | Month | 31 | Day |
Last modified on
| 2023 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058142
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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