UMIN-CTR Clinical Trial

Basic information
Public title	Surveillance in the digestive tract by capsule endoscopy after administration of immune checkpoint inhibitors
Acronym	Surveillance in the digestive tract after immunotherapy
Scientific Title	Surveillance in the digestive tract by capsule endoscopy after administration of immune checkpoint inhibitors
Scientific Title:Acronym	Surveillance in the digestive tract after immunotherapy
Region	Japan

Condition
Condition	Neoplasms (Malignant melanoma, Non-small cell lung cancer, and so on)
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the Gastrointestinal Tract in Patients with Abdominal symptoms after administration of immune checkpoint inhibitors
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Endoscopic findings and Prevalence rate
Key secondary outcomes

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	Capsule endoscope
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	Patients with planned immunotherapy or after administration of immune checkpoint inhibitors (within 28 days)
Key exclusion criteria	1. Pregnant female. 2. Patients with cardiac pacemakers or other medical electronic equipment. 3. Patients who have history of the ileus or stricture or fistula of the intestine. 4. Diagnosed or suspected Crohn&#39;s disease. 5. Patients with peritoneal dissemination. 6. Patients who are unsuccessful or difficult to perform esophagogastroduodenoscopy, colonoscopy, and small-bowel endoscopy. 7. Patients with dysphagia. 8. Allergy for mosapride, dimethicone, and low-volume polyethylene glycol solution (Moviprep). 9. Other conditions not suitable for this study.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuo Hamamoto, Kenro Hirata
Organization	Keio University School of Medicine
Division name	Gastroenterology and Hepatology
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	kenro916@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Kenro Hirata
Organization	Keio University School of Medicine
Division name	Gastroenterology and Hepatology
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	kenro916@gmail.com

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	None
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
Address
Tel
Email

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	2016 Year 07 Month 16 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	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
Date of IRB	2016 Year 07 Month 12 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date	2021 Year 03 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 04 Month 30 Day
Last modified on	2021 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025523