UMIN-CTR Clinical Trial

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	No longer 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	2022 Year 09 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048609