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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029315
Receipt No. 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 2019/05/15

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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 73 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.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.
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 4000

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
Email 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
Email yoshinak@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Guardant Health
Ono Pharmaceutical
Organization
Division
Category of Funding Organization Self funding
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, tyuo-ku, tokyo
Tel 03-3542-2511
Email 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
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
2024 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 2020 from research permit date

Management information
Registered date
2017 Year 09 Month 27 Day
Last modified on
2019 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033509

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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