UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046220 |
|---|---|
| Receipt number | 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 | 2023/12/13 12:59:04 |
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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
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
yuaoki2@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Not published.
Publication of results
Published
Result
URL related to results and publications
https://ascopubs.org/doi/full/10.1200/PO.22.00688
Number of participants that the trial has enrolled
212
Results
ctDNA genotyping effectively detected RAS/BRAF mutations, especially with sufficient ctDNA shedding. Clinical outcomes support ctDNA genotyping for determining the use of anti-EGFR and BRAF-targeted therapies in patients with mCRC.
Results date posted
| 2023 | Year | 12 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with mCRC enrolled in GOZILA between August 2018 and February 2020 who had available plasma- and tissue-based RAS/BRAF results before anti-EGFR therapy initiation were included in this study.
Participant flow
A retrospective observational study using genomic data and clinical information from the GOZILA Study.
Adverse events
Not applicable.
Outcome measures
Match rate of Guardant360 against RASKET-B in RAS and BRAF mutation
Efficacy of anti-EGFR and BRAF targeted therapy based on ctDNA assay.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052366
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