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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041710
Receipt No. R000047611
Scientific Title Integrated genomic and epigenomic analysis of circulating tumor DNA from hepatocellular carcinoma patients
Date of disclosure of the study information 2020/09/07
Last modified on 2020/09/07

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Basic information
Public title Integrated genomic and epigenomic analysis of circulating tumor DNA from hepatocellular carcinoma patients
Acronym COSMOS-HCC-01
Scientific Title Integrated genomic and epigenomic analysis of circulating tumor DNA from hepatocellular carcinoma patients
Scientific Title:Acronym COSMOS-HCC-01
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Positive rates of LUNAR assays in hepatocellular carcinoma
Basic objectives2 Others
Basic objectives -Others *LUNAR Assay Positivity by Stage (IA / IB / II / IIIA)
*Preoperative LUNAR assay positivity for ctDNA and prognosis
*Association of positive ctDNA and recurrence in the preoperative LUNAR assay
*Association of tumor markers (AFP, PIVKA-II, AFP-L3) with ctDNA positivity in LUNAR assays
*Agreement between LUNAR assay and genomic abnormalities in tumor tissue
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Positive rates of LUNAR assay in stage IA-IIIA hepatocellular carcinoma
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.The age at the date of obtaining the consent is 20 years or older
2.ECOG performance status is 0 or 1
3.Hepatocellular carcinoma has been diagnosed by abdominal ultrasonography, contrast-enhanced CT scan, contrast-enhanced MRI imaging*1 or histopathological examination.
4.Diagnosed with either a. through d. within 60 days prior to enrollment*2.
a. Clinical stage IA hepatocellular carcinoma (T1aN0M0)
b. Clinical stage IB hepatocellular carcinoma (T1bN0M0)
c. Clinical stage II hepatocellular carcinoma (T2N0M0)
d. Clinical stage IIIA hepatocellular carcinoma (T3N0M0)
5.No treatment prior to enrollment for hepatocellular carcinoma with eligibility criteria 3-4. and hepatic resection or ablation is planned after enrollment.
6.Child-Pugh score classification of A or B.
7.Willingness to submit blood and tissue specimens in accordance with the research protocol.
8.Consent has been obtained in writing.

*1 Abdominal ultrasound, contrast-enhanced CT or contrast-enhanced MRI imaging studies are all acceptable. However, it is preferable that all imaging tests be performed and comprehensively evaluated.

*2 A thoracoabdominal and pelvic CT or MRI scan to evaluate lymph node metastases and to exclude distant metastases must be performed.



Key exclusion criteria 1. a history of malignancy (excluding intraepithelial cancer) with a disease-free period of 5 years or less.
2. Clinically diagnosed cancer of another organ.
3. the presence of multiple tumors for which different treatments of hepatic resection and ablation are contemplated for each.
4. women who are pregnant or intend to become pregnant.
5. deemed unsuitable for enrollment in the study by the attending physician.
Target sample size 100

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
Email yoshinak@east.ncc.go.jp

Public contact
Name of contact person
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
Homepage URL
Email yoshinak@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization *Translational Research Support Section, National Cancer Center Hospital East.
*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 6-5-1, Kashiwanoha, Kashiwa, Chiba
Tel 04-7133-1111
Email irst@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 09 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 Preinitiation
Date of protocol fixation
2020 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 01 Day
Last follow-up date
2026 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 09 Month 07 Day
Last modified on
2020 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047611

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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