UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029315 |
|---|---|
| Receipt number | R000033509 |
| Scientific Title | Research on Liquid Biopsy in Patients with Gastrointestinal and Abdominal Malignancies, Including Colorectal Cancer |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2021/10/13 11:26:26 |
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Basic information
Public title
Research on Liquid Biopsy in Patients with Gastrointestinal and Abdominal Malignancies, Including Colorectal Cancer
Acronym
GOZILA Study
Scientific Title
Research on Liquid Biopsy in Patients with Gastrointestinal and Abdominal Malignancies, Including Colorectal Cancer
Scientific Title:Acronym
GOZILA Study
Region
| Japan |
Condition
Condition
Unresectable advanced or reccurrent gastrointestinal malignancies
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objectives of this study are to analyze circulating tumor DNA to identify cancer-associated genomic alterations using blood samples collected from patients with unresectable advanced or reccurrent gastrointestinal malignancies
Basic objectives2
Others
Basic objectives -Others
To investigate the relationships between cancer-associated genomic alterations in blood samples and clinicopathological and molecular biological profiles, clinical course, and cancer-associated genomic alterations in cancer tissue.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of genomic alterations in 74 cancer-associated genes detected by Guardant360
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. Must be aged 20 years or older at the time of consent;
2. Solid malignancies diagnosed by histopathological, cytological, or other examinations as the following:
i.Colorectal cancer ii.Gastric cancer iii.Esophageal cancer iv.Hepatocellular carcinoma v.Biliary cancer vi.Pancreatic cancer vii.Small intestine cancer viii.Appendix cancer ix.Anal canal cancer x.Neuroendocrine carcinoma of intestinal origin xi.Gastrointestinal stromal tumors xii.Breast cancer xiii.Head and Neck Cancer xiv.Other solid malignancies with specific genetic alterations
3. Must have an unresectable advanced/recurrent malignancy
4. Must have a life expectancy of at least 12 weeks;
5. Must have given written consent;
6. Must have disease progression confirmed on imaging or clinical PD suspected by the study doctor during drug therapy and must have not started subsequent therapy. However, patients with gastric, esophageal or colorectal cancer who has not received any chemotherapy, and patients with breast cancer who has not received any chemotherapy and has specific genetic alterations are eligible. It also targets pancreatic cancer patients under the age of 60 who have not been treated before chemotherapy.
Key exclusion criteria
1. Lymphoid malignancy
2. Have a history of bone marrow or organ transplantation;
3. Are pregnant; or
4. Are judged by the study doctor to be ineligible for the study for any other reason.
Target sample size
7000
Research contact person
Name of lead principal investigator
| 1st name | Yoshino |
| Middle name | |
| Last name | Takayuki |
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
04-7133-111
tyoshino@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
04-7133-111
Homepage URL
yoshinak@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Graduate School of Frontier Sciences, University of Tokyo
Name of secondary funder(s)
Guardant Health
Ono Pharmaceutical
Taiho Pharmaceutical
Takeda Pharmaceutical
Daiichi Sankyo Company
Merus N.V.
Hokkaido University Hospital
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1, tsukiji, tyuo-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
http://www.scrum-japan.ncc.go.jp/monstar_screen/institutions/index.html
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | 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
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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 meet the selection criteria until March 31 2024 from research permit date
Management information
Registered date
| 2017 | Year | 09 | Month | 27 | Day |
Last modified on
| 2021 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033509
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
