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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042490
Receipt No. 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 2020/11/18

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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
Email 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
Email shkobaya@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East, Japan
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 02 Month 01 Day
Last follow-up date
2025 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
2020 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048502

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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