Prostatic NeoplasmsNCT05941104
The Effect of Frailty on Blood Biology Indicators, Quality of Life and Survival of Patients With Radical Prostatectomy
An observational study of Prostatic Neoplasms and Frailty, run by Anhui Provincial Hospital.
Trial summary
The goal of this observational study is to evaluate the effect of frailty on blood biology indicators, quality of life and survival of patients with radical prostatectomy. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Frailty, Blood Biological Indicators
- What is being tested?
- frailty
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- Men only
- Adult, Older adult
Study population: Prostate cancer patients with Radical Prostatectomy.
Who may be able to join
- Diagnosed with prostate cancer (be diagnosed by relevant imaging examinations or pathology);
- Radical prostatectomy is planned;
- Voluntarily sign the informed consent form.
Who cannot join
- Diagnosed with other malignant tumors at the same time;
- Patients with acute infection.
About this study
The goal of this observational study is to evaluate the effect of frailty on blood biology indicators, quality of life and survival of patients with radical prostatectomy.
The main questions it aims to answer are:
- Evaluate the impact of frailty on the blood biological indicators, quality of life and survival of patients with radical prostatectomy, specifically.
- Describe the longitudinal changes in the quality of life of patients with radical prostatectomy.
Participants will be divided into frail group or non-frail group based on frailty assessment. Researchers will compare the two groups to see the impact of frailty on the blood biological indicators, quality of life and survival.
- Being tested
- frailty
- Medical subject headings
- Prostatic Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
frailtyOther
Frailty is a group of common clinical syndromes in the elderly, characterized by systematic, dynamic and reversible, the core of which is the decline of physiological reserves and the destruction of self-balance.
| Study group | Role | What they receive |
|---|---|---|
| Frail group | Not described Receives: Other: frailty | |
| Non-frail group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Quality of Life from baseline(Quality of Life is a generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease.)
Quality of life will be measured by the Extended Prostate Cancer Composite Index Scale (EPIC-26). EPIC-26 is used to assess the functional status of patients with prostate cancer in various domains over the past 4 weeks. Be si de s, EPIC-26 is used to describe the extent of its affects in life of patients with prostate cancer. EPIC-26 contains 26 items in five areas, including urinary incontinence, urinary tract irritation, defecation function, sexual function, and endocrine disorders. Cronbach α coefficient of the scale was 0.854. The overall score is 100 points, and the lower score means better quality of life.
Measured: baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.
Secondary outcomes (1)
Blood Biology Indicators(including IL-2, IL-6, IL-8,TNF-α, PSA and et al)
Measured: baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start15 Jul 2023 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941104
- Sponsor's protocol ID
- ShanShan Liu
- Status last verified
- Jun 2023
- First submitted
- 16 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Frailty on Blood Biology Indicators, Quality of Life and Survival of Patients With Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT05941104
- Acronym / sponsor ID
- ShanShan Liu
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 15 Jul 2023 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Jul 2023 (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.
The goal of this observational study is to evaluate the effect of frailty on blood biology indicators, quality of life and survival of patients with radical prostatectomy.
The main questions it aims to answer are:
- Evaluate the impact of frailty on the blood biological indicators, quality of life and survival of patients with radical prostatectomy, specifically.
- Describe the longitudinal changes in the quality of life of patients with radical prostatectomy.
Participants will be divided into frail group or non-frail group based on frailty assessment. Researchers will compare the two groups to see the impact of frailty on the blood biological indicators, quality of life and survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frail group | – | Other: frailty |
| Non-frail group | – | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Prostate cancer patients with Radical Prostatectomy.
Key inclusion criteria (3 listed)
- Diagnosed with prostate cancer (be diagnosed by relevant imaging examinations or pathology);
- Radical prostatectomy is planned;
- Voluntarily sign the informed consent form.
Key exclusion criteria (2 listed)
- Diagnosed with other malignant tumors at the same time;
- Patients with acute infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| frailtyFrailty is a group of common clinical syndromes in the elderly, characterized by systematic, dynamic and reversible, the core of which is the decline of physiological reserves and the destruction of self-balance. | Other | Frail group |
Primary outcome
Change of Quality of Life from baseline(Quality of Life is a generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease.)
Time frame: baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.
Quality of life will be measured by the Extended Prostate Cancer Composite Index Scale (EPIC-26). EPIC-26 is used to assess the functional status of patients with prostate cancer in various domains over the past 4 weeks. Be si de s, EPIC-26 is used to describe the extent of its affects in life of patients with prostate cancer. EPIC-26 contains 26 items in five areas, including urinary incontinence, urinary tract irritation, defecation function, sexual function, and endocrine disorders. Cronbach α coefficient of the scale was 0.854. The overall score is 100 points, and the lower score means better quality of life.
1 secondary outcome
Blood Biology Indicators(including IL-2, IL-6, IL-8,TNF-α, PSA and et al)
Time frame: baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms and Frailty, run by Anhui Provincial Hospital.
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 3 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: status not confirmed, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Quality of Life from baseline(Quality of Life is a generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease.) (time frame: baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.). 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 12 Jul 2023.