UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042588 |
|---|---|
| Receipt number | 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 | 2022/09/07 21:51:29 |
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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
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
ahamabe@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048609
