UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063466 |
|---|---|
| Receipt number | R000072638 |
| Scientific Title | Time Toxicity in Patients with Unresectable or Recurrent Pancreatic Cancer A Prospective Observational Study Evaluating Hours Away From Home |
| Date of disclosure of the study information | 2026/10/29 |
| Last modified on | 2026/10/29 18:07:04 |
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Basic information
Public title
Time Toxicity in Patients with Unresectable or Recurrent Pancreatic Cancer A Prospective Observational Study Evaluating Hours Away From Home
Acronym
Time Toxicity in Patients with Unresectable or Recurrent Pancreatic Cancer A Prospective Observational Study
Scientific Title
Time Toxicity in Patients with Unresectable or Recurrent Pancreatic Cancer A Prospective Observational Study Evaluating Hours Away From Home
Scientific Title:Acronym
Time Toxicity in Patients with Unresectable or Recurrent Pancreatic Cancer A Prospective Observational Study
Region
| Japan |
Condition
Condition
Unresectable or Recurrent Pancreatic Cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigating Time Toxicity in Patients with Pancreatic Cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall Time Toxicity Index
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient has been diagnosed with pancreatic cancer, either pathologically or clinically.At the time of enrollment, the patient has inoperable or recurrent pancreatic cancer, and is not receiving preoperative treatment intended to facilitate curative resection.The patient is scheduled to begin, or has just begun, systemic drug therapy for palliative intent as a new line of treatment.The patient is able to record the time in the study diary and complete the questionnaire.The patient has received a thorough explanation of this study, and written informed consent has been obtained of the patients own free will.
Key exclusion criteria
Patients undergoing preoperative chemotherapy with the intention of curative resection.
Patients whom the study coordinator determines are significantly unable to maintain a study diary.
Patients from whom it is difficult to obtain appropriate informed consent due to cognitive impairment or other reasons.
Any other patients whom the principal investigator or a co-investigator determines are unsuitable as study participants.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Isayama |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo Bunkyo-ku, Tokyo
TEL
03-3813-3111
h-isayama@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Takasaki |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
ytakasa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
the Japan Cancer Society
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
3-1-3, hongo Bunkyo-ku, Tokyo
Tel
0358021584
hongo-rinri@juntendo.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
| 2026 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 10 | Month | 29 | Day |
Last modified on
| 2026 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072638
