UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059879 |
|---|---|
| Receipt number | R000068482 |
| Scientific Title | An Observational Study to Evaluate the Clinical Utility of Serial Cancer Gene Panel Testing Using Circulating Tumor DNA in Patients with Metastatic Colorectal Cancer |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/25 22:55:52 |
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Basic information
Public title
An Observational Study to Evaluate the Clinical Utility of Serial Cancer Gene Panel Testing Using Circulating Tumor DNA in Patients with Metastatic Colorectal Cancer
Acronym
JAGUAR trial: JACCRO PM-01
Scientific Title
An Observational Study to Evaluate the Clinical Utility of Serial Cancer Gene Panel Testing Using Circulating Tumor DNA in Patients with Metastatic Colorectal Cancer
Scientific Title:Acronym
JAGUAR trial: JACCRO PM-01
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study will evaluate the clinical utility of performing sequential cancer gene panel testing by analyzing cancer-related genomic alterations-such as base substitutions, insertions/deletions, amplifications, and fusions-using the Guardant360 CDx cancer gene panel (Guardant360) before first-line chemotherapy and after confirmation of disease progression in patients with metastatic colorectal cancer who have not received systemic chemotherapy. The study will determine the proportion of patients with actionable genomic alterations and the proportion in whom such actionable gene alterations change over time.
Basic objectives2
Others
Basic objectives -Others
The clinical utility of performing sequential genomic profiling tests.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The proportion of subjects who showed changes in actionable gene alterations between the first and second gene panel tests, where actionable gene alterations were defined as those classified as therapeutic level 1, 2, or R1 by OncoKB (excluding VUS and synonymous variants)
Key secondary outcomes
･Proportion of subjects for whom treatment was recommended by the Expert Panel (at the 1st and 2nd tests) and the changes observed.
･Proportion of subjects harboring actionable gene alterations (at the 1st and 2nd tests).
･Proportion of subjects who received the Expert Panel-recommended treatment (at the 1st and 2nd tests) and the changes observed.
･Best overall response and progression-free survival (PFS) for the Expert Panel-recommended treatments.
･Proportion of subjects to whom Expert Panel results were explained via telemedicine (restricted to applicable institutions).
･Overall survival (OS).
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with histologically confirmed colorectal cancer (adenocarcinoma).
(2) Patients with unresectable colorectal cancer.
(3) Patients who are scheduled to receive systemic chemotherapy.
(4) Patients with no prior systemic chemotherapy for the current colorectal cancer (however, recurrence occurring >=24 weeks [168 days] after the last dose of perioperative chemotherapy is eligible).
(5) Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.
(6) Patients aged 18 years or older at the time of informed consent.
(7) Patients expected to survive for at least 3 months.
(8) Patients who have received adequate explanation regarding the study and have provided written informed consent.
Key exclusion criteria
(1) Patients with active double cancers*, including those occurring in the colon.
*Double cancer is defined as synchronous cancers or metachronous cancers with a disease-free interval of <=2 years. Lesions equivalent to carcinoma in situ or intramucosal carcinoma that are curable with local therapy are not considered active double cancers.
(2) Patients in whom blood collection is difficult.
(3) Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and are judged to make participation in the study difficult.
(4) Any other patients whom the principal investigator or a sub-investigator judges to be unsuitable for safe participation in the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Soichiro; Yu; Toshiki |
| Middle name | |
| Last name | Ishihara; Sunakawa; Masuishi |
Organization
The University of Tokyo; St. Marianna University School of Medicine; Aichi Cancer Center
Division name
Department of Surgical Pathology and Oncology; Department of Clinical Oncology; Department of Clinical Oncology
Zip code
113-8655; 216-8511; 464-8681
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan; 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan; 1-1 Shikanodono, Chikusa-ku, Nagoya, Aichi, Japan
TEL
03-3815-5411.044-977-8111.052-762-6111
pm01.dc@jaccro.or.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Sunakawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
y.sunakawa@marianna-u.ac.jp
Sponsor or person
Institute
Japan Clinical Cancer Research Organization (JACCRO)
Institute
Department
Personal name
Funding Source
Organization
Guardant Health Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Graduate School of Medicine and Faculty of Medicine, the University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.ac.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
東京大学医学部附属病院（東京都）、聖マリアンナ医科大学病院（神奈川県）、愛知県がんセンター（愛知県）、北海道大学病院（北海道）、東北大学病院（宮城県）、埼玉県立がんセンター（埼玉県）、千葉県がんセンター（千葉県）、大阪国際がんセンター（大阪府）、三重大学医学部附属病院（三重県）、四国がんセンター（愛媛県）、九州がんセンター（福岡県）
Other administrative information
Date of disclosure of the study information
| 2025 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2028 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 11 | Month | 30 | Day |
Other
Other related information
This study will evaluate the clinical utility of performing sequential cancer gene panel testing by analyzing cancer-related genomic alterations-such as base substitutions, insertions/deletions, amplifications, and fusions-using the Guardant360 CDx cancer gene panel (Guardant360) before first-line chemotherapy and after confirmation of disease progression in patients with metastatic colorectal cancer who have not received systemic chemotherapy. The study will determine the proportion of patients with actionable gene alterations and the proportion in whom such actionable gene alterations change over time.
Management information
Registered date
| 2025 | Year | 11 | Month | 25 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068482
