UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037765 |
|---|---|
| Receipt number | R000043004 |
| Scientific Title | Integrated analysis of genomic and epigenomic alterations in circulating tumor DNA in patients with colorectal cancer and advanced adenoma |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2024/05/01 14:26:44 |
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Basic information
Public title
Integrated analysis of genomic and epigenomic alterations in circulating tumor DNA in patients with colorectal cancer and advanced adenoma
Acronym
COSMOS-CRC-01
Scientific Title
Integrated analysis of genomic and epigenomic alterations in circulating tumor DNA in patients with colorectal cancer and advanced adenoma
Scientific Title:Acronym
COSMOS-CRC-01
Region
| Japan |
Condition
Condition
Colorectal cancer and advanced adenoma.
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the positive rate of LUNAR assay in colorectal cancer and advanced colorectal adenoma.
Basic objectives2
Others
Basic objectives -Others
Positive rate of LUNAR assay in each subgroup
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive rate of LUNAR assay in advanced colorectal adenoma and stage 0-2 colorectal 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. >= 20 years of age at the time of enrollment.
2. Confirmed as either of the following a-f by colonoscopy within 60 days before the enrollment.
a. Advanced colorectal adenoma (>= 10mm adenoma)
b. Clinical stage 0 (TisN0M0
c. Clinical stage I (T1-2N0M0)
d. Clinical stage IIA (T3N0M0)
e. Clinical stage IIB (T4aN0M0)
f. Clinical stage IIC (T4bN0M0)
3. Planned a resection for the colorectal cancer or advanced adenoma in the eligibility criteria #2.
4. Willing to provide blood samples per protocol.
5. Has given written consent.
Key exclusion criteria
1. Have previous history of cancer, including colorectal cancer, within 10 years before the enrollment.
2. Have previous history of colorectal advanced adenoma within 3 months before the enrollment.
3. Are suspected to have other malignancies by chest-abdomen-pelvic contrast CT within 60 days before the enrollment.
4. Are pregnant.
5. Are judged by the study doctor to be ineligible for the study for any other reason.
Target sample size
500
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
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
| 2019 | Year | 09 | Month | 01 | 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
| 2019 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2027 | 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
| 2019 | Year | 08 | Month | 22 | Day |
Last modified on
| 2024 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043004
