UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054568 |
|---|---|
| Receipt number | R000062340 |
| Scientific Title | Prospective Multicenter Observational Study of Disappearing Colorectal Liver Metastases |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2026/01/01 15:53:45 |
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Basic information
Public title
Prospective Multicenter Observational Study of Disappearing Colorectal Liver Metastases
Acronym
Kyoto-DLM Study
Scientific Title
Prospective Multicenter Observational Study of Disappearing Colorectal Liver Metastases
Scientific Title:Acronym
Kyoto-DLM Study
Region
| Japan |
Condition
Condition
colorectal liver metastases
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the negative predictive value of DLM diagnosed by EOB-MRI (3T, slice thickness of hepatobiliary phase with 2mm or less) for no residual tumor
Basic objectives2
Others
Basic objectives -Others
To evaluate the negative predictive value of DLM diagnosed by EOB-MRI (3T, slice thickness of hepatobiliary phase with 2mm or less) for no residual tumor
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
negative predictive value for no residual tumor
Key secondary outcomes
overall survival
intrahepatic recurrence free survival
recurrence free survival
factors predicting for no residual tumor
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
a) Patients with synchronous colorectal liver metastases who have disappearing liver metastases (DLM) which are detected by CT and EOB-MRI (3T, slice thickness of hepatobiliary phase with 2mm or less).
b) The lesions were detected by EOB-MRI (3T, slice thickness of hepatobiliary phase with 2mm or less) before or within a month after a beginning of the chemotherapy for synchronous colorectal liver metastases.
c) Patients who underwent thoracoabdominal CECT scan before or within a month after the beginning of the chemotherapy for synchronous colorectal liver metastases.
d) RAS mutation, BRAF mutation and MSI status of a primary colorectal cancer are known or planned to be tested.
e) Patients without allergic reaction to contrast medium and can undergo EOB-MRI.
f) Patients who are expected to survive more than 6 months.
g) Patients aged 18 years or older.
h) Patients without a possibility of pregnancy.
Key exclusion criteria
Patients who were diagnosed with any malignant tumors other than colorectal cancer and carcinoma in situ within the past two years.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Nishino |
Organization
Kyoto University Hospital
Division name
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3242
hnishino@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kojiro |
| Middle name | |
| Last name | Nakamura |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Surgery
Zip code
612-0861
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, 612-8555 Kyoto, Japan
TEL
075-641-9161
Homepage URL
kojiro@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
Tel
075-751-3111
ethcom@kuhp.kyoto-u.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
京都大学医学部附属病院（京都府）、大阪赤十字病院（大阪府）、関西電力病院（大阪府）、京都医療センター（京都府）、倉敷中央病院（岡山県）、神戸市立医療センター中央市民病院（兵庫県）、滋賀県立総合病院（滋賀県）、天理よろづ相談所病院（奈良県）、西神戸医療センター（兵庫県）、兵庫県立尼崎総合医療センター（兵庫県）、福岡大学病院（福岡県）、洛和会音羽病院（京都府）、京都桂病院（京都府）、静岡市立静岡病院（静岡県）、大阪府済生会野江病院（大阪府）、島根県立中央病院（島根県）、小倉記念病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | 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
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 06 | Month | 04 | Day |
Last modified on
| 2026 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062340
