UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040470 |
|---|---|
| Receipt number | R000046195 |
| Scientific Title | Integrated genomic and epigenomic analysis of blood circulating tumor DNA for pancreatic cancer |
| Date of disclosure of the study information | 2020/05/21 |
| Last modified on | 2025/05/29 10:47:32 |
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Basic information
Public title
Integrated genomic and epigenomic analysis of blood circulating tumor DNA for pancreatic cancer
Acronym
COSMOS-PC-01
Scientific Title
Integrated genomic and epigenomic analysis of blood circulating tumor DNA for pancreatic cancer
Scientific Title:Acronym
COSMOS-PC-01
Region
| Japan |
Condition
Condition
pancreatic cancer
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
LUNAR assay positive rate in resectable invasive pancreatic ductal carcinoma and IPMC
Basic objectives2
Others
Basic objectives -Others
Positive rates of LUNAR assays by histological diagnosis (invasive pancreatic ductal carcinoma/IPMC) and stage (0/IA/IB/IIA/IIB)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LUNAR assay positivity in Stage 0-IIB resectable invasive pancreatic ductal carcinoma and IPMC
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. Resectable invasive pancreatic ductal carcinoma or an IPMC diagnosis of any of the following a. to e. within 60 days prior to enrollment*1
a. Clinical stage 0 pancreatic cancer (TisN0M0)*2
b. Clinical stage IA pancreatic cancer (T1N0M0)*2
c. Clinical stage IB pancreatic cancer (T2N0M0)*2
d. Clinical stage IIA pancreatic cancer (T3N0M0)*2
e. Clinical stage IIB pancreatic cancer (T1-3N1M0)*2
3.Resection of invasive pancreatic ductal carcinoma or IPMC as described in 3.2 is contemplated.
4.No treatment for invasive pancreatic ductal carcinoma or IPMC.
5.Willingness to submit blood and tissue specimens in accordance with the research protocol.
6.Consent has been obtained in writing.
*1 The diagnosis of IPMC and clinical stage I-IIB requires that the patient has undergone thoraco-abdominal and pelvic CT or MRI within 60 days prior to enrollment to evaluate lymph node metastases and exclude distant metastases. Patients with allergies/sensitivities to contrast media may be performed without contrast media.
*2 Factors T and M of the clinical progression classification (cStage) follow the 8th edition of the UICC TNM classification, and factor N follows the 7th edition of the Pancreatic Cancer Treatment Protocol.
*3 Borderline resectable (BR) in the Resectability Classification (Pancreatic Cancer Treatment Protocol, 7th Edition) is subdivided into portal and arterial invasion. BR-PV (portal invasion only; no tumor contact or invasion of the superior mesenteric artery, celiac artery, or common hepatic artery, but contact, invasion, or occlusion of the superior mesenteric vein/portal vein greater than 180 degrees and not extending beyond the inferior duodenal border) is also eligible for enrollment.
Key exclusion criteria
1. A history of malignancy with a disease-free period of up to 5 years.*1
2. Clinically suspected coexistence of cancer of other organs.
3. Women who are pregnant or intend to become pregnant.
4. Your physician determines that you are unsuitable for enrollment in the study.
*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 completely resected cancer in the following pathological stages, is not excluded and can be registered. 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 Cancer of the uterus (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 (panniculocellular carcinoma, anaplastic pigment cell carcinoma): stage I, other intramucosal cancer equivalent lesions
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yoshino |
Organization
National Cancer Center Hospital East
Division name
Division for the Promotion of Drug and Diagnostic Development
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
gi-screen-jimukyoku@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
Division for the Promotion of Drug and Diagnostic Development
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 | 05 | Month | 21 | 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
501
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 | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 30 | 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 | 05 | Month | 21 | Day |
Last modified on
| 2025 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046195
