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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000046220
Receipt No. R000052366
Scientific Title Concordance study between Guardant360 and RASKET-B(MEBGEN) of RAS/BRAF evaluation in colorectal cancer. (GOZILA additional study).
Date of disclosure of the study information 2021/12/01
Last modified on 2022/01/17

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Basic information
Public title Concordance study between Guardant360 and RASKET-B(MEBGEN) of RAS/BRAF evaluation in colorectal cancer. (GOZILA additional study).
Acronym GOZILA-RAS/BRAF
Scientific Title Concordance study between Guardant360 and RASKET-B(MEBGEN) of RAS/BRAF evaluation in colorectal cancer. (GOZILA additional study).
Scientific Title:Acronym GOZILA-RAS/BRAF
Region
Japan

Condition
Condition Patients with unresectable advanced/recurrent colorectal cancers.
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We investigate the correlation between the results of RAS/BRAF by Guardant360 and by the previously approved MEBGEN RASKET-B kit in patients with unresectable colorectal cancer, as an ancillary study using the clinical information and test results obtained in the "GOZILA study", which purpose is to profile cancer-related genetic abnormalities in circulating tumor DNA (ctDNA) of patients with advanced or recurrent gastrointestinal or abdominal malignancies.
If this study shows acceptable concordance, Guardant360 would be allowed to be used as a companion diagnostics of RAS/BRAF status to use EGFR inhibitors.
Basic objectives2 Others
Basic objectives -Others Evaluate the correlation between the results of RAS/BRAF evaluated by Guardant360 and previously approved MEBGEN RASKET-B kit.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall percent agreement (OPA), positive percent agreement (PPA), and negative percent agreement (NPA) of RAS mutations by Guardant360 in comparison with those assessed by RASKET-B.
OPA, PPA, NPA of BRAF V600E mutations by Guardant360 in comparison with those assessed by RASKET-B.
Key secondary outcomes 1.The concordance rate between Guardant360 and RASKET-B for RAS and BRAF mutations evaluated under the effect of extravasation of ctDNA with different threshold settings for Max MAF (Mutant Allelic Fraction) values.
2.The concordance rate between Guardant360 and RASKET-B per variant in RAS mutation-positive patients.
3.The concordance rate between Guardant360 and RASKET-B for RAS and BRAF mutations in the drug-naive and drug-treated groups, respectively.
4.The concordance rate between Guardant360 and RASKET-B for RAS and BRAF mutations by metastatic organs.

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) Colorectal cancer patients who participate in GOZILA study between August 1st, 2018 and February 29, 2020 and can provide written informed consent for secondary use.
2) Patients whose Guardant360 results are available for analysis in this study.
3) Patients whose RAS/BRAF status by RASKET-B kit (MEBGEN) are available.
Key exclusion criteria Patients who are inappropriate to participate in this study for any reasons.
Patients who have been treated with anti-EGFR antibody at the time of first collecting blood.
Target sample size 350

Research contact person
Name of lead principal investigator
1st name Yoshiaki
Middle name
Last name Nakamura
Organization National Cancer Center Hospital East
Division name Department of Gastroenterrelogy and Gastroint estinal Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa Chiba
TEL 04-7133-1111
Email yoshinak@east.ncc.go.jp

Public contact
Name of contact person
1st name Yu
Middle name
Last name Aoki
Organization National Cancer Center Hospital East
Division name Department of Gastroenterrelogy and Gastroint estinal Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa Chiba
TEL 04-7133-1111
Homepage URL
Email yuaoki2@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Guardant Health Japan Corp.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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
2021 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 350
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
2021 Year 09 Month 28 Day
Date of IRB
2021 Year 11 Month 22 Day
Anticipated trial start date
2021 Year 12 Month 13 Day
Last follow-up date
2022 Year 01 Month 31 Day
Date of closure to data entry
2022 Year 01 Month 31 Day
Date trial data considered complete
2022 Year 01 Month 31 Day
Date analysis concluded
2022 Year 05 Month 31 Day

Other
Other related information A retrospective observational study using the date or information GOZILA Study
December,2021 to December31,2023

Management information
Registered date
2021 Year 11 Month 29 Day
Last modified on
2022 Year 01 Month 17 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052366

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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