UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043131 |
|---|---|
| Receipt number | R000049237 |
| Scientific Title | Case-control and etiological studies on the efficacy of screening for prostate cancer |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2021/01/26 08:17:49 |
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Basic information
Public title
Assessment for screening for prostate cancer in Gunma
Acronym
Assessment for screening for prostate cancer in Gunma
Scientific Title
Case-control and etiological studies on the efficacy of screening for prostate cancer
Scientific Title:Acronym
PROstate Cancer Screening study on Death due to prostate cancer (PROCEED)
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Combining individual data on screening for prostate cancer and cancer registry including prognostic survey in Gunma Prefecture, and subsequently investigating relationship between screening history and risk of death due to prostate cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Case control study in Isesaki city (old Isesaki city; original community before municipal merger) and in Gunma prefecture excluding Isesaki city.
Investigating relationship between PSA-based screening history and death due to prostate cancer (estimating odds ratio) in men aged below 85 years old (the age of having life expectancy of 7 years or longer) Candidates for influencing factor on screening histories are followings;
1) Population-based PSA screening history before cancer detection: none vs. present
2) Diagnostic opportunity (data from MN report): screening vs. outpatient clinic due to having any urinary symptoms
3) Population-based PSA screening history within 2 years before cancer detection: none vs. present
4) Population-based PSA screening history within 5 years before cancer detection: none vs. present
5) Population-based PSA screening history within 5 years before cancer detection: none or only once vs. present more than once
Key secondary outcomes
<1> Case control study in Isesaki city (old Isesaki city; original community before municipal merger) and in Gunma prefecture excluding Isesaki city.
Investigating relationship between PSA-based screening history and death due to prostate cancer in men dead at the age below 85 years old in Isesaki city (old Isesaki city) and in Gunma prefecture excluding Isesaki city. Candidates for influencing factor on screening histories are followings;
Population-based PSA screening history within 10 years before cancer detection:
1) none vs. present
2) none or only once vs. present more than once
3) none, once, twice vs. present more than twice
Investigating above indicated primary and secondary outcomes in men dead due to prostate cancer at the age below 80 years old or 75 years old
<2> Retrospective cohort study: Estimating cumulative risk of detecting prostate cancer in the late clinical stage and death due to prostate cancer stratified by baseline PSA (0.0-1.0/1.1-2.0/2.1-3.0/3.1-4.0/4.1-10.0/10.1-20.0/20.1-50.0/50.1 or higher) and the age (50-54/55-59/60-64/65-69/70-74/75-79 years old)
<3> Etiological study
1) Time series study: Estimating relationship of annual percent change (APC) in age standardized incidence of prostate cancer (1992-2015), age standardized incidence of metastatic prostate cancer (1992-2015) and age standardized mortality of prostate cancer (1992-2020) with exposure rate of PSA screening until 2019, stratified by municipality and the year of initiation of population-based screening
2) Regional correlation study: Grouping municipalities according to exposure rate of PSA screening between the year of initiation of PSA screening and 2019, and subsequently investigating relationship between exposure rate of PSA screening and APC in age standardized incidence of prostate cancer (1992-2015), age standardized incidence of metastatic prostate cancer (1992-2015) and age standardized mortality of prostate cancer (1992-2020)
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
Key inclusion criteria
1) Men aged above 20 years old and participating population-based screening for prostate cancer in Gunma Prefecture* between April 1992 and March 2020. *municipalities where Gunma Health Foundation have gotten entrusted population-based screening
2) Men aged above 20 years old and participating population-based screening for prostate cancer in old Isesaki city between April 2002 and March 2020.
3) Men diagnosed with prostate cancer and registered in Gunma Prefecture Cancer Registry between January 1992 and December 2015 from the municipalities where Gunma Health Foundation or Isesaki prostate cancer screening committee have conducted population-based screening
Key exclusion criteria
1) All inhabitants living in the municipalities decided not to participate in the present study (clarified the intention of opt-out for the present study)
2) All individuals who clarified the intention of opt-out for the present study (excluding data for the case-control study and the retrospective cohort study)
3) All individuals who died or could not clarify their own intention and whom direct relatives clarified the intention of opt-out for the present study (excluding data for the case-control study and the retrospective cohort study)
4) Men whom physicians or researchers recommended to exclude from the present study.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Sekine |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Urology
Zip code
3718511
Address
3-39-22, Showa-machi, Maebashi-city, Gunma 371-8511, Japan
TEL
027-220-8306
ysekine@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Sekine |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Urology
Zip code
3718511
Address
3-39-22, Showa-machi, Maebashi-city, Gunma 371-8511, Japan
TEL
027-220-8306
Homepage URL
ysekine@gunma-u.ac.jp
Sponsor or person
Institute
Department of Urology, Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Gunma University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Gunma Prefecture Cancer Registry
Gunma Health Foundation
Isesaki prostate cancer screening committee
Gunma University Center Mathematics and Data Science
Department of Public Health, Gunma University Graduate School of Medicine
Gunma Prefectural Institute of Public Health and Environmental Sciences
Institute for Preventive Medicine, Kurosawa Hospital
Name of secondary funder(s)
Institute for Preventive Medicine, Kurosawa Hospital
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
3-39-22, Showa-machi, Maebashi-city, Gunma 371-8511, Japan
Tel
027-220-8741
eguchi@jimu.gunma-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
| 2021 | Year | 02 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The analysis will be done by using the coupled databases of screening, cancer registration and information of prognosis, which were numbered without reference to individual informations, in both "Gunma University Center Mathematics and Data Science" and "Department of Urology, Gunma University Graduate School of Medicine".
Registrations in the databases are followings:
1) Individual number
2) Screening : hometown, age at the screening, PSA, history of complete examination, history of prostate biopsy, result of screening
3) Cancer registration : entries recorded in MN report
4) Information of prognosis : survival confirmation date, date of death due to prostate cancer, date of death due to other causes
Management information
Registered date
| 2021 | Year | 01 | Month | 26 | Day |
Last modified on
| 2021 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049237
