UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040148 |
|---|---|
| Receipt number | R000045778 |
| Scientific Title | Integrated genomic and epigenomic analysis of blood circulation tumor DNA from gastric cancer and gastric GIST patients |
| Date of disclosure of the study information | 2020/04/13 |
| Last modified on | 2025/05/23 17:43:38 |
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Basic information
Public title
Integrated genomic and epigenomic analysis of blood circulation tumor DNA from gastric cancer and gastric GIST patients
Acronym
COSMOS-GC-01
Scientific Title
Integrated genomic and epigenomic analysis of blood circulation tumor DNA from gastric cancer and gastric GIST patients
Scientific Title:Acronym
COSMOS-GC-01
Region
| Japan |
Condition
Condition
Gastric cancer, GIST
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Positive rates of LUNAR assays in gastric and gastric GIST
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 Stage-I-III gastric cancer and gastric GIST
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
Gastric cancer cohort
1.The age at the date of obtaining the consent is 20 years or more.
2.Histopathologically diagnosed as gastric adenocarcinoma.
3.A diagnosis of any of a. to d. on upper gastrointestinal endoscopy and thoracoabdominal/pelvic CT scan within 60 days before enrollment
a. Clinical stage I gastric cancer (T1-2N0M0)
b. Clinical stage IIA gastric cancer (T1-2N1-3M0)
c. Clinical stage IIB gastric cancer (T3-4aN0M0)
d. Clinical stage III gastric cancer (T3-4aN1-3M0)
4.No prior treatment for gastric cancer with eligibility criteria 2-3. and resection is contemplated post-registration.
5.Willing to submit blood and tissue specimens in accordance with the research protocol.
6.Consent has been obtained in writing.
Gastric GIST cohort A
1.The age at the date of obtaining the consent is 20 years or more.
2.Gastric GIST is suspected or histopathologically diagnosed as gastric GIST on upper gastrointestinal endoscopy within 60 days prior to enrollment.
3.No obvious distant metastasis or peritoneal dissemination on CT examination of the thorax and pelvis
4.No prior pre-registration treatment for gastric GIST with eligibility criterion 2 and curative resection is contemplated post-registration.
5.Willing to submit blood and tissue specimens in accordance with the research protocol.
6.Consent has been obtained in writing.
Gastric GIST cohort B
1.The age at the date of obtaining the consent is 20 years or more.
2.Histopathologically diagnosed as gastric GIST.
3.No obvious distant metastasis or peritoneal dissemination on CT examination of the thorax and pelvis
4.Curative resection for gastric GIST with eligibility criteria 2 and continued use of imatinib for at least 2 years as perioperative therapy or within 6 months of completion of at least 3 years of imatinib as perioperative therapy.
5.Willing to submit blood and tissue specimens in accordance with the research protocol.
6.Consent has been obtained in writing.
Key exclusion criteria
Gastric cancer cohort
1. a history of malignancy (including gastric cancer) with a disease-free period of up to 10 years.
2.Duplicate cancers are suspected on chest and pelvic CT scan within 60 days before enrollment.
3. Are pregnant.
4. the attending physician determines that you are unsuitable for enrollment in the study.
Gastric GIST cohort A
1.History of malignancy (including gastric GIST) with a disease-free period of up to 10 years.
2.Duplicate cancers are suspected by chest and pelvic CT scan within 60 days before enrollment.
3.Are pregnant.
4.Your physician determines that you are unsuitable for enrollment in the study.
Gastric GIST cohort B
1.A history of malignancy (including gastric GIST) with a disease-free period of up to 10 years prior to resection of gastric GIST with eligibility criterion 2.
2.Duplicate cancers are suspected by chest and pelvic CT scan within 60 days before enrollment.
3.Are pregnant.
4.Your physician determines that you are unsuitable for enrollment in the study.
Target sample size
600
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
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 | 04 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2028 | 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 | 04 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045778
