UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057007 |
|---|---|
| Receipt number | R000064766 |
| Scientific Title | Assessment of Residual Or Resected Disappearing Liver Metastases After Chemotherapy: AROD study |
| Date of disclosure of the study information | 2025/02/15 |
| Last modified on | 2025/02/12 20:18:18 |
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Basic information
Public title
Assessment of Residual Or Resected Disappearing Liver Metastases After Chemotherapy: AROD study
Acronym
AROD study
Scientific Title
Assessment of Residual Or Resected Disappearing Liver Metastases After Chemotherapy: AROD study
Scientific Title:Acronym
AROD study
Region
| Japan |
Condition
Condition
Colorectal liver metastasis
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prognosis of resected and unresected cases of colorectal liver metastases that disappeared after chemotherapy.
Basic objectives2
Others
Basic objectives -Others
Observational Study (Non-controlled Exploratory Clinical Research)
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The recurrence rate at the site of disappeared liver metastases (DLM) in unresected cases and the pathological tumor residual rate in resected DLM cases.
Key secondary outcomes
Recurrence rate, survival rate, prognostic factors, patterns of recurrence, and trends in serum tumor markers.
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
This study includes patients with colorectal liver metastases (CLM) diagnosed as disappearing liver metastases (DLM) before surgery among those who underwent hepatic resection after preoperative chemotherapy during the study period.
The study comprises a prospective cohort and a retrospective cohort. Patients scheduled for hepatic resection of CLM, including DLM, will be enrolled in the prospective cohort. Patients who had already undergone hepatic resection for CLM, including DLM, prior to the start of the study will be included in the retrospective cohort. The retrospective cohort will target cases from the past two years.
Key exclusion criteria
1. Patients under 20 years of age at the time of consent acquisition.
2. Cases where contrast-enhanced CT or MRI was not feasible.
3. Patients deemed unfit for surgery based on their overall condition.
4. Cases with more than 50 liver metastases prior to treatment, as accurately counting them was deemed impractical.
5. Other cases deemed unsuitable as study subjects by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Takahashi |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
Division name
Division of Hepatobiliary and Pancreatic Surgery
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo
TEL
0335200111
yu.takahashi@jfcr.or.jp.
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Kobayashi |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
Division name
Division of Hepatobiliary and Pancreatic Surgery
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo
TEL
0335200111
Homepage URL
kkobayashi-tki@umin.ac.jp
Sponsor or person
Institute
Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo
Institute
Department
Personal name
Funding Source
Organization
none
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
Cancer Institute Ethical Review Board, Japanese Foundation for Cancer Research
Address
3-8-31 Ariake, Koto-ku, Tokyo
Tel
0335200111
kosuke.kobayashi@jfcr.or.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
がん研有明病院消化器センター(東京都)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 15 | 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
40
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
| 2022 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational studies (uncontrolled exploratory clinical studies)
Management information
Registered date
| 2025 | Year | 02 | Month | 12 | Day |
Last modified on
| 2025 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064766
