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

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 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

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

Value
https://center6.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