UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055757 |
|---|---|
| Receipt number | R000063678 |
| Scientific Title | An observational study to evaluate the impact of waiting time in the blood testing and medical flow for cancer patients |
| Date of disclosure of the study information | 2024/10/07 |
| Last modified on | 2025/11/05 09:21:54 |
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Basic information
Public title
An observational study to evaluate the impact of waiting time in the blood testing and medical flow for cancer patients
Acronym
An observational study to evaluate the impact of waiting time in the blood testing and medical flow for cancer patients
Scientific Title
An observational study to evaluate the impact of waiting time in the blood testing and medical flow for cancer patients
Scientific Title:Acronym
An observational study to evaluate the impact of waiting time in the blood testing and medical flow for cancer patients
Region
| Japan |
Condition
Condition
Solid cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
By collecting blood samples at the collaborating institution prior to the day of systemic chemotherapy and obtaining the results in advance, we will compare the waiting time on the day of chemotherapy with the waiting time on the day of chemotherapy for the same patients who did not have their blood tests in advance (normal blood tests). The impact on labor productivity from a health economics perspective will also be evaluated secondarily.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Waiting time1 Time spent at the collaborating institution for preliminary blood test and waiting time from the start of reception to the start of consultation on the day of chemotherapy at the implementing institution.
Waiting time2 Waiting time from the start of reception to the start of consultation on the day of chemotherapy at the implementing medical institution when blood test are not taken in advance.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.At least 18 years old at the time of obtaining consent
2.Cancer patients scheduled for or receiving systemic chemotherapy
3.Possible to visit research partner institutions that conduct blood sampling in advance
4.Can answer surveys
5.The principal investigator or research associate can determine that the investigator or research associate has the ability to understand and comply with the content of the clinical research
6.Able to sign and date ICF prior to enrollment in this study
Key exclusion criteria
1.Patients receiving oral anticancer drugs only or hospitalized and not scheduled to use an outpatient chemotherapy unit
2.The principal investigator or principal research scientist determines that the subject is inappropriate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Sunakawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
0449778111
y.sunakawa@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Manami |
| Middle name | |
| Last name | Onoue |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
0449778111
Homepage URL
manami1o@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Takeda Pharmaceutical Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel
0449778111
k-sienbu.mail@marianna-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 07 | 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
50
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
| 2024 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 08 | Month | 31 | Day |
Other
Other related information
This is a single-center, single-arm, open-label observational study to evaluate the impact of waiting time on cancer patients undergoing or scheduled to begin systemic chemotherapy treatment. After obtaining consent, we will collect information on the patient's hospital stay and costs on the day of preliminary blood sampling and the day of chemotherapy. In addition, as control data, we will extract data from medical records from the days immediately prior to or after the day of study participation when chemotherapy was administered at a regular hospital visit for the same patients and with the same regimen, and compare the hospital stay time.
Management information
Registered date
| 2024 | Year | 10 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063678
