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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042588
Receipt No. R000048609
Scientific Title A prospective study to predict the risk for recurrence of advanced rectal cancer based on combined analysis of MRI and ctDNA
Date of disclosure of the study information 2020/11/29
Last modified on 2020/11/29

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Basic information
Public title A prospective study to predict the risk for recurrence of advanced rectal cancer based on combined analysis of MRI and ctDNA
Acronym A prospective study to predict the risk for recurrence of advanced rectal cancer based on combined analysis of MRI and ctDNA
Scientific Title A prospective study to predict the risk for recurrence of advanced rectal cancer based on combined analysis of MRI and ctDNA
Scientific Title:Acronym A prospective study to predict the risk for recurrence of advanced rectal cancer based on combined analysis of MRI and ctDNA
Region
Japan

Condition
Condition rectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate the relevance of the combined analysis of MRI and ctDNA for the recurrence of advanced rectal cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 2-year disease free survival
Key secondary outcomes ctDNA positivity rate
MRI findings (mesorectal fascia involvement, EMVI, T factor, N factor)
Pathological findings
2y-local recurrence-free survival
2y-overall survival

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 1st inclusion
1) Suspected advanced rectal cancer (T2-4)
2) Age is 20 years old or more
3) Informed consent is obtained

2nd inclusion
1) Histologically confirmed rectal cancer (pap, tub, por, muc, sig, med, asc)
2) Stage II-IV
3) The lower border of the tumor is closer than 12cm from anal verge.
Key exclusion criteria 1st exclusion
1) Synchronous distant metastasis or double cancer is confirmed at first visit of the patient
2) Multiple malignancies
3) Patients whose consent ability is judged to be insufficient (dementia etc.)
4) Other, patients judged inappropriate by investigators

2nd exclusion
1) Multiple malignancies that is diagnosed after 1st inclusion
2) Other, patients judged inappropriate by investigators after 1st inclusion
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Takemasa
Organization Sapporo Medical University Hospital
Division name Department of surgery, surgical oncology and science
Zip code 060-8543
Address 291, South1 West16, Chuo-ku, Sapporo, Hokkaido
TEL 011-611-2111
Email itakemasa@sapmed.ac.jp

Public contact
Name of contact person
1st name Atsushi
Middle name
Last name Hamabe
Organization Sapporo Medical University Hospital
Division name Department of surgery, surgical oncology and science
Zip code 060-8543
Address 291, South1 West16, Chuo-ku, Sapporo, Hokkaido
TEL 011-611-2111
Homepage URL
Email ahamabe@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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 Sapporo medical university hospital institutional review board
Address 291, South1 West16, Chuo-ku, Sapporo, Hokkaido
Tel 011-611-2111
Email ji-rskk@sapmed.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

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 29 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 07 Month 18 Day
Date of IRB
2020 Year 09 Month 10 Day
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2020 Year 11 Month 29 Day
Last modified on
2020 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048609

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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