UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016344 |
|---|---|
| Receipt number | R000018971 |
| Scientific Title | The Nationwide Cancer Genome Screening Projects for Gastrointestinal Cancer in Japan, Efficient Identification of Actionable Cancer Genome Alterations in Advanced Non-Colorectal Gastrointestinal Cancer (SCRUM-Japan GI Screen 2015-01-Non-CRC) |
| Date of disclosure of the study information | 2015/01/26 |
| Last modified on | 2025/06/03 16:52:47 |
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Basic information
Public title
The Nationwide Cancer Genome Screening Projects for Gastrointestinal Cancer in Japan, Efficient Identification of Actionable Cancer Genome Alterations in Advanced Non-Colorectal Gastrointestinal Cancer (SCRUM-Japan GI Screen 2015-01-Non-CRC)
Acronym
SCRUM-Japan GI Screen 2015-01- Non-CRC
Scientific Title
The Nationwide Cancer Genome Screening Projects for Gastrointestinal Cancer in Japan, Efficient Identification of Actionable Cancer Genome Alterations in Advanced Non-Colorectal Gastrointestinal Cancer (SCRUM-Japan GI Screen 2015-01-Non-CRC)
Scientific Title:Acronym
SCRUM-Japan GI Screen 2015-01- Non-CRC
Region
| Japan |
Condition
Condition
Gastrointestinal cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the frequency or characteristics of cancer genome alterations in advanced non-colorectal gastrointestinal cancers
Basic objectives2
Others
Basic objectives -Others
To evaluate the frequency or characteristics of cancer genome alterations in advanced non-colorectal gastrointestinal cancers,Quality of the specimen contributing to gene analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency or characteristics of cancer genome alteration
Key secondary outcomes
Association between each cancer genome alterations and clinicopathological characteristics or prognosis,Quality of the specimen contributing to gene analysis
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 with histologically confirmed or clinically suspected advanced cancer of following descriptions; 1.gastric or gastro-esophageal junction adenocarcinoma 2.Esophageal cancer(adenocarcinoma or squamous cell carcinoma) 3.Others (adenocarcinoma of small intestine, appendiceal adenocarcinoma, anal cancer, neuroendocrine carcinoma which includes mixed type with adenocarcinoma)
2) Planned to receive systemic chemotherapy for advanced disease
3) Presence or ability to acquire sufficient DNA for target sequencing
4) Written informed consent was obtained
Key exclusion criteria
1) Patient is judged by the investigator to be inappropriate for study participation for any reason.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yoshino |
Organization
National Cancer Center Hospital East
Division name
Gastrointestinal Oncology Division
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
81-47-133-1111
tyoshino@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Shitara |
Organization
National Cancer Center Hospital East
Division name
Gastrointestinal Oncology Division
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
Homepage URL
kshitara@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
SCRUM Japan
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
0335422511
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
| 2015 | Year | 01 | Month | 26 | Day |
Related information
URL releasing protocol
https://scrum-japan.ncc.go.jp/monstar-screen/about/
Publication of results
Published
Result
URL related to results and publications
https://scrum-japan.ncc.go.jp/monstar-screen/achievement/
Number of participants that the trial has enrolled
2952
Results
From SCRUM-Japan GI-screen 2013-01-CRC study and GI Screen 2015-01-Non-CRC study, total 5743 patients were analyzed. The landscape of genomic alterations was comparable to that reported in other profiling studies in Western countries. RNA sequencing performed using the OCA assay aided the successful identification of rare fusions involving ERBB2, FGFR2 or3, RET, ROS1, NTRK, and others. Clinical outcomes have been updated with a median follow-up time of more than 3 years.
Results date posted
| 2025 | Year | 06 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with histopathologically confirmed unresectable or meta-static GI cancer who had received or were scheduled to receive sys-temic therapy were eligible.
Participant flow
Genotyping of archival formalin-fixedparaffin-embedded (FFPE) tumor tissues derived from enrolled pa-tients was performed using the Oncomine Comprehensive Assay(OCA; Thermo Fisher Scientific) v1 between February 2015 andMarch 2017 and OCA v3 between April 2017 and April 2019 atthe Life Technologies Clinical Services Lab, a CLIA-certified, CAP-accredited laboratory. Theseassays covered 143 (OCA v1) and 161 (OCA v3) cancer-relatedgenes and detected the relevant single-nucleotide variants (SNVs),copy number variations, gene fusions, and indels in a streamlined.
Adverse events
None
Outcome measures
The landscape of genomic alterations was comparable to that reported in other profiling studies in Western countries and revealed a high prevalence of mutations in trunk genes such as TP53, and a considerable number of alterations were detected at a low prevalence showing a long-tail distribution. RNA sequencing performed using the OCA assay aided the successful identification of rare fusions involving ERBB2, FGFR2 or3, RET, ROS1, NTRK, and others.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Each cancer genome alterations and clinicopathological characteristics or prognosis,Quality of the specimen contributing to gene analysis
Management information
Registered date
| 2015 | Year | 01 | Month | 26 | Day |
Last modified on
| 2025 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018971
