UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062698 |
|---|---|
| Receipt number | R000071791 |
| Scientific Title | A Single-Center Prospective Pilot Study on the Safety and Feasibility of Colon Capsule Endoscopy for Evaluating Colitis after Hematopoietic Stem Cell Transplantation |
| Date of disclosure of the study information | 2026/08/26 |
| Last modified on | 2026/08/26 15:40:34 |
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Basic information
Public title
A Study on the Safety of Colon Capsule Endoscopy for Post-Transplant Colitis
Acronym
SAFE_CCE study
Scientific Title
A Single-Center Prospective Pilot Study on the Safety and Feasibility of Colon Capsule Endoscopy for Evaluating Colitis after Hematopoietic Stem Cell Transplantation
Scientific Title:Acronym
SAFE_CCE study
Region
| Japan |
Condition
Condition
Hematologic Malignancies, Graft Versus Host Disease, Cytomegalovirus Colitis
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study focuses on patients suspected gut-GVHD or CMV colitis after hematopoietic stem cell transplantation and aims to evaluate the clinical safety and feasibility of using a colon capsule endoscopy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of exam-related adverse events in colon capsule endoscopy for patients with colitis after HSCT
Key secondary outcomes
Small intestine image depicting rate, large intestine image depicting rate, stomach transit time, small intestine transit time, large intestine transit time, small intestine exam completion rate, large intestine exam completion rate, large intestine capsule endoscopy retrieval rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Colon Capsule Endoscopy
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We'll make anyone who meets all of the following criteria a study participant.
1) Patients who are between 18 and 75 years old at the time of consent
2) Patients who have undergone hematopoietic stem cell transplantation
3) Patients suspected of having post-transplant enteritis
4) Patients who have given written consent
Key exclusion criteria
Exclude from the study anyone who meets any of the following criteria:
1) Patients suspected of having an intestinal blockage
2) Patients with kidney problems (eGFR below 30)
3) Patients who have trouble swallowing or have esophageal narrowing
4) Patients for whom a colon capsule endoscopy isn't covered by insurance
5) Anyone else the principal investigator thinks isn't suitable
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Takamaru |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
htakamar@ncc.go.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Takamaru |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
Homepage URL
htakamar@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
0335422511
irst@ncc.go.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
| 2026 | Year | 08 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 26 | Day |
Last modified on
| 2026 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071791
