UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052780 |
|---|---|
| Receipt number | R000060172 |
| Scientific Title | Integrated analysis of genomic and epigenomic alterations in circulating tumor DNA in patients with biliary tract cancer |
| Date of disclosure of the study information | 2023/11/14 |
| Last modified on | 2024/04/23 09:46:44 |
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Basic information
Public title
Integrated analysis of genomic and epigenomic alterations in circulating tumor DNA in patients with biliary tract cancer
Acronym
COSMOS-BTC-01
Scientific Title
Integrated analysis of genomic and epigenomic alterations in circulating tumor DNA in patients with biliary tract cancer
Scientific Title:Acronym
COSMOS-BTC-01
Region
| Japan |
Condition
Condition
Biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
GUARDANT assay positivity in resectable biliary tract cancer
Basic objectives2
Others
Basic objectives -Others
GUARDANT assay positivity by stage and cancer type.
Association of ctDNA positivity in the GUARDANT assay with recurrence-free survival, overall survival and disease-specific survival.
Association of ctDNA positivity in the GUARDANT assay with CA19-9.
Concordance rates between the GUARDANT assay and genomic aberrations in tumour tissue.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive rates of GUARDANT assays in resectable biliary tract cancer
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
1.18 years of age or older
2.Clinically diagnosed with biliary tract cancer with one of the following in the UICC TNM classification, 8th edition.
a. Intrahepatic cholangiocarcinoma, clinical stage I (T1N0M0) to IV (AnyTAnyNM1)
b. Hilar cholangiocarcinoma, clinical stage 0 (TisN0M0) to IVB (AnyTAnyNM1)
c. Distal cholangiocarcinoma, clinical stage 0 (TisN0M0) to IIIB (T4AnyNM0)
d. Gallbladder cancer, clinical stage 0 (TisN0M0) to IVB (AnyTAnyNM1)
e. Papilla Vater carcinoma , clinical stage 0 (TisN0M0) to IIIB (T4AnyNM0)
3.Resection of biliary tract cancer in 2 is planned.
4.Complete resection (R0/1 resection) is deemed possible.
5.No previous treatment for biliary tract cancer.
6.Willing to submit blood and tissue samples according to the study protocol
7.Written consent has been obtained.
Key exclusion criteria
1.History of malignancy with a disease-free period of 5 years or less. *1
2.Clinically suspected coexistence of cancer of other organs.
3.Women who are pregnant or intend to become pregnant.
4.Judged by physician to be unsuitable for enrolment in the study.
*1Pre-existing cancer with a disease-free interval of less than 5 years, but with a 5-year relative survival equivalent to 95% or more, such as stage I prostate cancer, stage 0 or stage I laryngeal cancer with a complete response to radiotherapy, or cancer of the following pathological stages that has been completely resected, will not be excluded and will be eligible for enrolment.
Gastric cancer (adenocarcinoma [general type]): Stage 0 - Stage I
Colorectal cancer (adenocarcinoma): Stage 0 - Stage I
Esophageal cancer (flat epithelial carcinoma, adeno flat epithelial carcinoma, basaloid 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 body cancer (endometrioid adenocarcinoma, mucinous adenocarcinoma): stage IA
Anterior adenocarcinoma (adenocarcinoma): Stage I - IIA
Cervical Cancer (Flat Epithelial Carcinoma): Stage IA
Thyroid Cancer (Breast Cancer, Follicular Cancer): Stage I, II, III
Kidney Cancer (Haplocellular Carcinoma, Haplocellular Carcinoma): Stage I
Other Intramucosal Cancer Comparable Transformation
Target sample size
110
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
gi-screen-jimukyoku@east.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
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
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 | 11 | Month | 14 | 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 | 24 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: Observational study
Target population:the patients who meet the selection criteria until June 30 2025 from research permit date
Management information
Registered date
| 2023 | Year | 11 | Month | 13 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060172
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| Registered date | File name |
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