Urological MalignanciesNCT04625556
Development of Urologic Registry for Personalized Medicine in Patients With Urologic Malignant Diseases by Analyzing Microbiome
An observational study of Urological Malignancies and Prostate Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Genitourinary malignancies such as prostate cancer, renal cell cancer, and bladder cancer in Korean population have been increased due to the aged population and the westernized lifestyles. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Urological Malignancies, Prostate Cancer, Renal Cell Cancer
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Dec 2022to Oct 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone surgeries with urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) in Severance Hospital, Sinchon from 2020.10 and 2030.10 were selected.
Who may be able to join
- Patients diagnosed as urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer)
- Patients who have undergone surgeries due to urological malignancies in Severance Hospital, Sinchon from 2020.10 and 2030.10
- Those who agree to give permission to use their human source information
- Those who agree with this study
Who cannot join
- Those who do not agree with this study
- Vulnerable participants who are likely to be vulnerable to coercion or undue influence or lack decision-making
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei Severance Hospital
Seoul
Won Sik Ham, 82-02-2228-2310, uroham@yuhs.ac
About this study
Genitourinary malignancies such as prostate cancer, renal cell cancer, and bladder cancer in Korean population have been increased due to the aged population and the westernized lifestyles. With the advancement of technologies, studies have found that microbiome not only affects human physiological functions, such as metabolism, immunity, and haematopoiesis, but also plays a significant role in the development and progression of malignancies. However, the investigation of microbiome in urological malignances have been limited and few studies have been reported. Therefore, the investigator tried to evaluate the usefulness of microbiome in detection and monitoring of urological malignancies in Korean population. This study aims to use microbiome in tissue, plasma, stool and urine for the diagnosis, disease progression monitoring and therapeutic response evaluation. This study plan includes building big databases for microbiome of urological malignancies in Korean population.
- Conditions
- Urological Malignancies, Prostate Cancer, Renal Cell Cancer, Bladder Cancer, Ureter Cancer
- Medical subject headings
- Prostatic Neoplasms, Carcinoma, Renal Cell, Urinary Bladder Neoplasms, Ureteral Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer | Patients diagnosed as prostate cancer and have undergone prostatectomy | |
| Renal cell cancer | Patients diagnosed as renal cell cancer and have undergone partial or radical nephrectomy | |
| Bladder cancer | Patients diagnosed as bladder cancer and have undergone radical or partial cystectomy | |
| Ureter cancer | Patients diagnosed as ureter cancer and have undergone nephroureterectomy or ureterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between tissue bacteria composition and prevalence of urological malignancies
evaluate and compare the bacteria composition in tissue samples in urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) with healthy control group
Measured: within 2 weeks after the surgery
Correlation between plasma bacteria composition and prevalence of urological malignancies
evaluate and compare the bacteria composition in plasma samples in urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) with healthy control group
Measured: within 2 weeks after the surgery
Correlation between stool bacteria composition and prevalence of urological malignancies
evaluate and compare the bacteria composition in stool samples in urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) with healthy control group
Measured: within 2 weeks after the surgery
Correlation between urine bacteria composition and prevalence of urological malignancies
evaluate and compare the bacteria composition in urine samples in urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) with healthy control group
Measured: within 2 weeks after the surgery
Secondary outcomes (1)
Correlation of bacteria composition and tumor response assessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Association between bacteria composition and oncological prognosis, progression, and therapeutic response in urological malignancies
Measured: within 10 years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start19 Dec 2022
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urological MalignanciesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Won Sik Ham, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625556
- Sponsor's protocol ID
- 4-2020-1018
- Status last verified
- Jan 2023
- First submitted
- 29 Oct 2020
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Urologic Registry for Personalized Medicine in Patients With Urologic Malignant Diseases by Analyzing Microbiome
- ClinicalTrials.gov ID
- NCT04625556
- Acronym / sponsor ID
- 4-2020-1018
- Conditions
- Urological Malignancies, Prostate Cancer, Renal Cell Cancer, Bladder Cancer, Ureter Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Genitourinary malignancies such as prostate cancer, renal cell cancer, and bladder cancer in Korean population have been increased due to the aged population and the westernized lifestyles. With the advancement of technologies, studies have found that microbiome not only affects human physiological functions, such as metabolism, immunity, and haematopoiesis, but also plays a significant role in the development and progression of malignancies. However, the investigation of microbiome in urological malignances have been limited and few studies have been reported. Therefore, the investigator tried to evaluate the usefulness of microbiome in detection and monitoring of urological malignancies in Korean population. This study aims to use microbiome in tissue, plasma, stool and urine for the diagnosis, disease progression monitoring and therapeutic response evaluation. This study plan includes building big databases for microbiome of urological malignancies in Korean population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer | – | –Patients diagnosed as prostate cancer and have undergone prostatectomy |
| Renal cell cancer | – | –Patients diagnosed as renal cell cancer and have undergone partial or radical nephrectomy |
| Bladder cancer | – | –Patients diagnosed as bladder cancer and have undergone radical or partial cystectomy |
| Ureter cancer | – | –Patients diagnosed as ureter cancer and have undergone nephroureterectomy or ureterectomy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone surgeries with urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) in Severance Hospital, Sinchon from 2020.10 and 2030.10 were selected.
Key inclusion criteria (4 listed)
- Patients diagnosed as urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer)
- Patients who have undergone surgeries due to urological malignancies in Severance Hospital, Sinchon from 2020.10 and 2030.10
- Those who agree to give permission to use their human source information
- Those who agree with this study
Key exclusion criteria (2 listed)
- Those who do not agree with this study
- Vulnerable participants who are likely to be vulnerable to coercion or undue influence or lack decision-making
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between tissue bacteria composition and prevalence of urological malignancies
Time frame: within 2 weeks after the surgery
evaluate and compare the bacteria composition in tissue samples in urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) with healthy control group
Correlation between plasma bacteria composition and prevalence of urological malignancies
Time frame: within 2 weeks after the surgery
evaluate and compare the bacteria composition in plasma samples in urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) with healthy control group
Correlation between stool bacteria composition and prevalence of urological malignancies
Time frame: within 2 weeks after the surgery
evaluate and compare the bacteria composition in stool samples in urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) with healthy control group
Correlation between urine bacteria composition and prevalence of urological malignancies
Time frame: within 2 weeks after the surgery
evaluate and compare the bacteria composition in urine samples in urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) with healthy control group
1 secondary outcome
Correlation of bacteria composition and tumor response assessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Time frame: within 10 years after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Won Sik Ham principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urological Malignancies and Prostate Cancer, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Won Sik Ham (82-02-2228-2310, uroham@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between tissue bacteria composition and prevalence of urological malignancies (time frame: within 2 weeks after the surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.