UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041710 |
|---|---|
| Receipt number | 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 | 2023/03/30 16:36:16 |
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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.
*3 In cases where ablation is being contemplated, transcatheter arterial chemoembolization (TACE) or transcatheter arterial embolization (TAE) may be performed prior to ablation as an additional treatment.
Key exclusion criteria
1. a history of malignancy (excluding intraepithelial cancer) with a disease-free period of 5 years or less. *1
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. Preoperative adjuvant therapy is contemplated prior to liver resection or ablation.*2
5.women who are pregnant or intend to become pregnant.
6. deemed unsuitable for enrollment in the study by the attending physician.
*1 Even if the disease-free period is less than 5 years, a history of cancer with a 5-year relative survival rate equivalent to 95% or higher, such as stage I prostate cancer, stage 0 and stage I laryngeal cancer with complete response to radiotherapy, and the following pathological stages of cancer that have been completely resected, can be registered without exclusion. Gastric cancer (adenocarcinoma (general type)): stage 0-I, colon cancer (adenocarcinoma): stage 0-I, rectal cancer (adenocarcinoma): stage 0-I, esophageal cancer (squamous cell carcinoma, adenosquamous cell carcinoma, basal cell carcinoma): stage 0, breast cancer (non-invasive ductal carcinoma, non-invasive lobular carcinoma): stage 0, breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, Paget's disease): stage 0-IIA Uterine cancer (endometrial adenocarcinoma, mucinous adenocarcinoma): stage IA, Prostate cancer (adenocarcinoma): stage I-II, Cervical cancer (squamous cell carcinoma): stage IA, Thyroid cancer (papillary carcinoma, follicular carcinoma): stage I, II, III, Renal cancer (panniculocarcinoma, anaplastic pigment cell carcinoma): stage I, Other intramucosal cancer equivalent lesions
*2 Postoperative adjuvant therapy after liver resection or ablation is contemplated is acceptable.
Target sample size
200
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 | 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
yoshinak@east.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 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2029 | 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
| 2023 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047611
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