UMIN-ICDS Clinical Trial

Public title

Study of Surveillance after Endoscopic Resection of T1 Colorectal Cancer

Acronym

Study of Surveillance after Endoscopic Resection of T1 Colorectal Cancer

Scientific Title

A Cohort Study on Current Surveillance Practices and Optimization after Endoscopic Resection of T1 Colorectal Cancer

Scientific Title:Acronym

T1-CRC Surveillance Study

Region

Japan

Condition

T1 colorectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To clarify the actual surveillance practices and clinical outcomes in patients with T1 colorectal cancer treated with endoscopic resection alone.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Recurrence after endoscopic resection of T1 colorectal cancer (presence or absence of recurrence, pattern of recurrence, the examination that first raised suspicion of recurrence and the date on which it was performed, the examination that confirmed recurrence and the date on which it was performed, and the reason for performing these examinations [symptomatic evaluation or routine surveillance in asymptomatic patients]).

Key secondary outcomes

1. Final clinical outcome
2. Development of metachronous colorectal cancer, advanced colorectal lesions, and colorectal adenomas

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

100

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients who underwent endoscopic resection for T1 colorectal cancer at Fukushima Medical University Aizu Medical Center or Jichi Medical University Hospital between September 2010 and August 2021.

Key exclusion criteria

1. Patients who underwent additional intestinal resection after endoscopic resection.
2. Patients with lymph node or distant metastasis at the time of endoscopic resection.
3. Patients with synchronous advanced colorectal cancer or a synchronous non-colorectal malignancy at the time of endoscopic resection.
4. Patients with known hereditary colorectal cancer syndromes, such as Lynch syndrome or familial adenomatous polyposis.

Target sample size

480

Name of lead principal investigator

1st name	Kazutomo
Middle name
Last name	Togashi

Organization

Fukushima Medical University

Division name

Aizu Medical Center

Zip code

969-3492

Address

21-2 Maeda, Yazawa, Kawahigashi-machi, Aizuwakamatsu, Fukushima 969-3492, Japan

TEL

0242-75-2100

Email

togashik@fmu.ac.jp

Name of contact person

1st name	Kakeru
Middle name
Last name	Otomo

Organization

Fukushima Medical University

Division name

Aizu Medical Center

Zip code

969-3492

Address

21-2 Maeda, Yazawa, Kawahigashi-machi, Aizuwakamatsu, Fukushima 969-3492, Japan

TEL

0242-75-2100

Homepage URL

Email

be59733a729@fmu.ac.jp

Institute

Fukushima Medical University

Institute

Department

Personal name

Organization

Fukushima Medical University

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Fukushima Medical University

Address

1 Hikarigaoka, Fukushima, Fukushima, Japan

Tel

0245471825

Email

fmurec@fmu.ac.jp

Secondary IDs

YES

Study ID_1

REC2026-121

Org. issuing International ID_1

Ethics Committee of Fukushima Medical University

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

福島県立医科大学会津医療センター（福島県）、自治医科大学（栃木県）

Date of disclosure of the study information

2026

Year

09

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

09

Month

15

Day

Date of IRB

Anticipated trial start date

2026

Year

09

Month

24

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Descriptive statistics will be used to summarize recurrence after endoscopic resection of T1 colorectal cancer, including the presence or absence of recurrence, pattern of recurrence, the examination that first raised suspicion of recurrence and the date on which it was performed, the examination that confirmed recurrence and the date on which it was performed, and the reason for performing these examinations (evaluation prompted by symptoms or routine surveillance in asymptomatic patients). The incidence proportion of recurrence will be reported with its exact 95% confidence interval. The cumulative incidence of recurrence will be estimated using the cumulative incidence function (CIF), with death treated as a competing risk. Recurrence-free survival will be estimated using the Kaplan-Meier method.

Registered date

2026

Year

09

Month

17

Day

Last modified on

2026

Year

09

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072089