UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042490 |
|---|---|
| Receipt number | R000048502 |
| Scientific Title | Multi-center clinical trial for personalized perioperative chemotherapy based on genetic alteration status for resectable oligometastases from colorectal cancer |
| Date of disclosure of the study information | 2020/11/18 |
| Last modified on | 2022/05/22 05:35:37 |
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Basic information
Public title
Clinical trial of personalized therapy based on genetic alteration for patients with resectable colorectal oligometastases
Acronym
Personalized therapy for resectable colorectal oligometastases
Scientific Title
Multi-center clinical trial for personalized perioperative chemotherapy based on genetic alteration status for resectable oligometastases from colorectal cancer
Scientific Title:Acronym
PRECISION Study
Region
| Japan |
Condition
Condition
Colorectal oligometastases
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To prospectively analyze the survival impact of pre-treatment ctDNA analysis on resectable colorectal oligometastases
Basic objectives2
Others
Basic objectives -Others
To investigate the proof of concept of pre-treatment ctDNA analysis for personalized perioperative chemotherapy of resectable colorectal oligometastases
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of BRAF V600E mutation and pre-treatment ctDNA detection in patients with resectable colorectal oligometastases
Key secondary outcomes
Survival outcomes depending on status of BRAF V600E mutation and pre-treatment ctDNA detection. Genetic alteration profiles according to ctDNA analysis.
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. Above 20 years of age
2. Written informed consent
3. Colorectal cancer origin
4. Resectable oligometastases
5. Initial surgery is planed.
6. R0/1 resection is possible.
7. ECOG PS 0/1
In G360 cohort, in which pre-treatment ctDNA is analyzed, below criteria are also added.
1. Pathologically-proven adnocarcinoma
2. No prior treatment for oligometastases
3. Written consent for blood test
Key exclusion criteria
1. Concomittant unresectable advanced tumor
2. Prior surgery for oligometastases
3. Unresectable unless the tumor is shrinked by preoperative chemotherapy
4. Physician`s judgement for exclusion
In G360 cohort, below criteria are also added.
1. Concomittant tumor that is disease-free within 5 years
2. Pathological diagnosis other than adenocarcinoma
3. Any prior treatment for oligometastases
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Kobayashi |
Organization
National Cancer Center Hospital East, Japan
Division name
Department of Hepatobiliary and Pancreatic Surgery
Zip code
277-0882
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan, 2770882
TEL
04-7133-1111
shkobaya@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Kobayashi |
Organization
National Cancer Center Hospital East, Japan
Division name
Department of Hepatobiliary and Pancreatic Surgery
Zip code
277-0882
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan, 2770882
TEL
04-7133-1111
Homepage URL
shkobaya@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East, Japan
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital East, Japan
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan, 2770882
Tel
04-7133-1111
shkobaya@east.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
| 2020 | Year | 11 | Month | 18 | 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
| 2020 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 11 | Month | 18 | Day |
Last modified on
| 2022 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048502
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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