UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031242 |
|---|---|
| Receipt number | R000035671 |
| Scientific Title | Identification of Site-specific Genome Alterations in Advanced Colorectal Cancer (SCRUM-Japan GI-screen 2013-01-CRC substudy 003) |
| Date of disclosure of the study information | 2018/02/10 |
| Last modified on | 2022/08/15 13:44:51 |
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Basic information
Public title
Identification of Site-specific Genome Alterations in Advanced Colorectal Cancer (SCRUM-Japan GI-screen 2013-01-CRC substudy 003)
Acronym
SCRUM-Japan GI-screen 2013-01-CRC substudy 003
Scientific Title
Identification of Site-specific Genome Alterations in Advanced Colorectal Cancer (SCRUM-Japan GI-screen 2013-01-CRC substudy 003)
Scientific Title:Acronym
SCRUM-Japan GI-screen 2013-01-CRC substudy 003
Region
| Japan |
Condition
Condition
Advanced colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To determine the site-specific gene mutation profiles in advanced colorectal cancer.
Basic objectives2
Others
Basic objectives -Others
Association between site-specific gene mutation profiles and clinical background, including therapeutic efficacy of anti-EGFR therapies or anti-angiogenic agents
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
site-specific gene mutation profiles in advanced 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients enrolled in SCRUM-Japan GI-Screen 2013-01-CRC from Feb. 2015 on, and whose cancer genome alterations were decided by OCP.
2)Patients who agreed to the secondary usage of specimen when they agreed to GI-Screen 2013-01-CRC, and did not revoked their agreements.
Key exclusion criteria
1)Patients whose specimens were collected from metastatic site or unknown.
2)Patients who have administerd chemotherapy, including anti-EGFR therapies or anti-angiogenetic agents for metastatic disease before collecting the specimens.
3)Judged by the investigator to be inappropriate for study participation for any reason
Target sample size
1011
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | Eguchi |
| Last name | Takako |
Organization
St. Marianna University School of Medicine
Division name
Clinical Oncology
Zip code
2168511
Address
Sugao 2-16-1, Miyamae, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
tnakajima@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuro |
| Middle name | |
| Last name | Takuro |
Organization
St. Marianna University School of Medicine
Division name
Clinical Oncology
Zip code
2168511
Address
Sugao 2-16-1, Miyamae, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
t3mizukami@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
SCRUM Funds
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cancer Center Hospital East
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School
Address
Sugao 2-16-1, Miyamae, Kawasaki, Kanagawa
Tel
044-977-8111
t3mizukami@marianna-u.ac.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
| 2018 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
https://doi.org/10.1007/s11523-022-00880-3
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s11523-022-00880-3
Number of participants that the trial has enrolled
569
Results
Patients with right-sided tumors had worse survival,left-sided tumors with wt RAS had favorable outcomes when treated with anti-EGFR antibodies and cecum tumors had a poor prognosis when treated with bevacizumab. The rate of gene alterations varied depending on the primary site. In addition, gene alterations of KRAS, BRAF, SMAD4, or TP53 had different contributions to survival from site to site. KRAS, BRAF, PTEN, or SMAD4 mutations were associated with the efficacy of bevacizumab or anti-EGFR mAb.
Results date posted
| 2022 | Year | 08 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The relationship between PTS, genomic alterations, and clinical outcomes was evaluated in untreated mCRC patients using real-world data of a prospective observational study, SCRUM-Japan GI-SCREEN with clinical and genomic data set in 1,011 patients enrolled from February 2015 to March 2017.
Participant flow
NA
Adverse events
NA
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 01 | 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 enrolled GI-SCREEN 2013-01-CRC from Feb. 2015 and meet the selection criteria.
Management information
Registered date
| 2018 | Year | 02 | Month | 10 | Day |
Last modified on
| 2022 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035671
