UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037808 |
|---|---|
| Receipt number | R000043100 |
| Scientific Title | Research on required specifications of tele-monitoring system for oncology patients receiving ambulatory chemotherapy treatments |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2020/08/28 16:41:22 |
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Basic information
Public title
Research on required specifications of tele-monitoring system for oncology patients receiving ambulatory chemotherapy treatments
Acronym
Research on required specifications of tele-monitoring system for oncology patients receiving ambulatory chemotherapy treatments
Scientific Title
Research on required specifications of tele-monitoring system for oncology patients receiving ambulatory chemotherapy treatments
Scientific Title:Acronym
Research on required specifications of tele-monitoring system for oncology patients receiving ambulatory chemotherapy treatments
Region
| Japan |
Condition
Condition
gastric cancer, colorectal cancer, breast cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the specifications required for tele-monitoring systems used by outpatients who recieve chemotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Availability of tele-monitoring system
Key secondary outcomes
Results obtained during the tele-monitoring system usage period
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients register their vital information and interview items every day on a patient lending terminal for tele-monitoring.
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
1. Patients with gastric cancer, colorectal cancer, or breast cancer
2. Patients recieving chemotherapy using the following drugs at an outpatient clinic
i S-1
ii capecitabin
iii regorafenib
iv TAS-102
v tegafur-uracil
3. Patients who can operate iPad or iPhone by themselves
Key exclusion criteria
1. Patients who cannot operate iPad or iPhone by themselves
2. Patients who have confirmed adverse events with the above drugs
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Uehara |
Organization
Nagoya University Hospital
Division name
Gastrointestinal Surgery
Zip code
466-8550
Address
65 Tsurimai-cho, Showa-ku, Nagoya
TEL
+81-52-744-2222
kuehara@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Akitaka |
| Middle name | |
| Last name | Sugishita |
Organization
Nagoya University Hospital
Division name
Center for Advanced Medicine and Clinical Research
Zip code
466-8550
Address
65 Tsurimai-cho, Showa-ku, Nagoya
TEL
+81-52-744-2942
Homepage URL
asugishita@med.nagoya-u.ac.jp
Sponsor or person
Institute
Gastrointestinal Surgery, Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Philips Comprehensive-Care Co-Creation Research Division
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Cancer Treatment Center, Center Hospital of the National Center for Global Health and Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Review Section, Management Planning Division, Nagoya University Graduate School of Medicine
Address
65 Tsurimai-cho, Showa-ku, Nagoya
Tel
+81-52-744-2479
iga-shinsa@adm.nagoya-u.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
名古屋大学医学部附属病院（愛知県）、国立国際医療研究センター がん総合診療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 27 | Day |
Last modified on
| 2020 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043100
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
