UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038400 |
|---|---|
| Receipt number | R000043760 |
| Scientific Title | The feasibility study for adenocarcinoma screening by novel urinary biomarker using protein fragments: a cross-sectional study |
| Date of disclosure of the study information | 2019/10/31 |
| Last modified on | 2024/03/25 17:51:47 |
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Basic information
Public title
The feasibility study for adenocarcinoma screening by novel urinary biomarker using protein fragments: a cross-sectional study
Acronym
The feasibility study for adenocarcinoma screening by novel urinary biomarker using protein fragments: a cross-sectional study
Scientific Title
The feasibility study for adenocarcinoma screening by novel urinary biomarker using protein fragments: a cross-sectional study
Scientific Title:Acronym
The feasibility study for adenocarcinoma screening by novel urinary biomarker using protein fragments: a cross-sectional study
Region
| Japan |
Condition
Condition
adenocarcinoma (gastric cancer, colorectal cancer, or bile duct cancer)
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the diagnostic accuracy of urinary protein fragment for adenocarcinoma in patients with gastric cancer, colorectal cancer, or bile duct cancer, and compare the accuracy of protein fragments with established blood tumour markers (CEA or CA19-9).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of diagnostic accuracy of urinary protein fragments and carcinoembryonic antigen (CEA) for adenocarcinoma (gastric cancer, colorectal cancer, or bile duct cancer)
Key secondary outcomes
1)Comparison of diagnostic accuracy of urinary protein fragment and CA19-9 for adenocarcinoma
2)Diagnostic accuracy of combination marker (urinary protein fragments, CEA and CA19-9)
3)Comparison of diagnostic accuracy of urinary protein fragments and blood tumor marker(CEA or CA19-9) for gastric cancer
4)Comparison of diagnostic accuracy of urinary protein fragments and blood tumor marker(CEA or CA19-9) for colorectal cancer
5)Comparison of diagnostic accuracy of urinary protein fragments and blood tumor marker(CEA or CA19-9) for bile duct cancer
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adenocarcinoma group
1.Patients aged equal to or greater than 20 years-old.
2.Patients who have the schedule for surgical treatment, endoscopic submucosal dissection, or endoscopic mucosal resection.
3. Patients diagnosed adenocarcinoma by histopathology.
4. Patients who had a detailed briefing of the trial prior to the enrollment and voluntarily signed a consent form.
Disease control group
1.Patients aged equal to or greater than 20 years-old.
2. Patients who were clinicaly diagnosed gastrointestinal inflammation by gastoroscopy or colonoscopy within 3 months or who were clinicaly diagnosed cholelithiasis or colonic diverticulitis by CT within 6 months.
3.Patients who had a detailed briefing of the trial prior to the enrollment and voluntarily signed a consent form.
Healthy controls
1. Those who are equal to or greater than 20 years-old at the time of obtaining informed consent.
2. Those who have no abnormal findings in chest X-ray, blood glucose levels, serum lipids, serum liver function, serum renal function, and urinalysis within one year of obtaining informed consent.
3. Those who do not receive any regular prescriptions.
4. Those who had a detailed briefing of the trial prior to the enrollment and voluntarily signed a consent form
Key exclusion criteria
Adenocarcinoma group
1. Patients who do not have the schedule for surgical treatment, endoscopic submucosal dissection, or endoscopic mucosal resection.
2. Patients who received chemotherapy or endoscpic treatment.
3. Patients who have proteinuria, positive urine sugar or urine occult blood in urinalysis.
4. Patients who have renal dysfunction (Serum levels of creatinine > 2.0 mg/dl).
5. Patients who have alcohol or drug dependence or who are suspected to have alcohol or drug dependence.
6. Patients who is pregnant or who is suspected to be pregnant.
7. Patients who was enrolled another clinical trial and was prescribed a study drug within one month.
8. Patients whose attending physicians consider to be inappropriate for this study.
Disease control group
1. Patients who were not clinicaly diagnosed gastrointestinal inflammation by gastoroscopy or colonoscopy within 3 months or who were not clinicaly diagnosed cholelithiasis or colonic diverticulitis by CT within 6 months.
2. Patients who have proteinuria, positive urine sugar or urine occult blood in urinalysis.
3. Patients who have renal dysfunction (Serum levels of creatinine > 2.0 mg/dl).
4. Patients who have alcohol or drug dependence or who are suspected to have alcohol or drug dependence.
5-7. Same criterias as Adenocarcinoma group (6-8).
Healthy controls
1. Those who have not received a medical check within one year.
2. Those who have abnormal findings in chest X-ray, blood test or urine test within one year of obtaining informed consent.
3. Those who have current malignant neoplasm other than lung squamous cell carcinoma, or past history of malignant neoplasm within 5 years.
4. Those who have alcohol or drug dependence or who are suspected to have alcohol or drug dependence.
5-7. Same criterias as Adenocarcinoma group (6-8).
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masamitsu |
| Middle name | |
| Last name | Nakazato |
Organization
University of Miyazaki
Division name
Neurology, Respirology, Endocrinology and Metabolism, Internal Medicine, Faculty of Medicine
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki, Japan
TEL
0985-85-2965
nakazato@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hironobu |
| Middle name | |
| Last name | Tsubouchi |
Organization
University of Miyazaki
Division name
Neurology, Respirology, Endocrinology and Metabolism, Internal Medicine, Faculty of Medicine
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki, Japan
TEL
0985-85-2965
Homepage URL
hironobu_tsubouchi@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Miyazaki
Address
5200 Kihara, Kiyotake, Miyazaki, Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-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
宮崎大学医学部附属病院
和歌山県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 31 | 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
| 2019 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043760
