Secondary HyperparathyroidismNCT06378931
Quality of Life Change in Patients Undergoing Parathyroidectomy With End-stage Renal Failure
An observational study of Secondary Hyperparathyroidism and End Stage Renal Failure, run by Chunling Jiang.
Trial summary
The purpose of this study is to characterize the quality of life change in patients undergoing parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism, End Stage Renal Failure
- What is being tested?
- Quality of life progression after parathyroidectomy
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2024to 30 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure will be invited to participate in this study.
Who may be able to join
- Age: ≥18 years old;
- Patients scheduled for parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure
Who cannot join
- Patients refuse to participate
Trial locations and contacts
No sites are listed yet.
Chunling Jiang contact
About this study
Official title: Quality of Life Change in Patients Undergoing Parathyroidectomy With Secondary Hyperparathyroidism Due to End-stage Renal Failure: a Prospective Cohort Study
The purpose of this study is to characterize the quality of life change in patients undergoing parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure.
Read the detailed description
Study participants will be asked questions about age, gender, education level, clinical symptoms, intensities of depression and anxiety, etc, and they will also be questioned regarding the prior quality of life score, as measured by the health-related quality of life 36-item Short-Form (SF-36) survey before surgery. Then, study participants will be contacted at one, three, six months, and 1 year after surgery, and asked questions about their SF-36 score, depression, and anxiety intensity.
- Being tested
- Quality of life progression after parathyroidectomy
- Medical subject headings
- Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life progression after parathyroidectomyOther
Study the progression of quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Quality of life change in patients Undergoing Parathyroidectomy with end-stage renal failure | Quality of Life Progression in Patients Undergoing Parathyroidectomy With Secondary Hyperparathyroidism Due to End-stage Renal Failure Receives: Other: Quality of life progression after parathyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure quality of life scores change with respect to time
Quality of life will be assessed by the 36-Item short form health survey scale, Subjects complete one response from a range of options for each of the 36 questions. A combination of item response is then aggregated to calculate a score for each of the eight dimensions listed. The scores for each dimension range from 0 to 100, with higher scores indicating better health status
Measured: up to 1 year
Secondary outcomes (3)
Measure anxiety and depression score change with respect to time
The anxiety and depression were evaluated using Hospital anxiety and depression Scale (HADS). The HADS consists of 14 questions, with 7 items each for the anxiety and depression subscales. The score for each item ranges from 0 to 3 points, and scores are summed to yield a separate score for anxiety (HADS-A) and depression (HADS-D).
Measured: up to 1 year
Measure bone pain scores change with respect to time
The bone pain is evaluated using numerical rating scale (NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.
Measured: up to 1 year
Length of hospital stay
Determined by the number of days from admittance to discharge
Measured: through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start15 Apr 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chunling Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chunling Jiang, West China Hospital
- Investigators
- Chunling Jiang, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378931
- Sponsor's protocol ID
- 2024HX161
- Status last verified
- Mar 2024
- First submitted
- 26 Mar 2024
- Last updated
- 23 Apr 2024
- 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 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Change in Patients Undergoing Parathyroidectomy With Secondary Hyperparathyroidism Due to End-stage Renal Failure: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06378931
- Acronym / sponsor ID
- 2024HX161
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chunling JiangUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 23 Apr 2024 (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 purpose of this study is to characterize the quality of life change in patients undergoing parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure.
Detailed description
Study participants will be asked questions about age, gender, education level, clinical symptoms, intensities of depression and anxiety, etc, and they will also be questioned regarding the prior quality of life score, as measured by the health-related quality of life 36-item Short-Form (SF-36) survey before surgery. Then, study participants will be contacted at one, three, six months, and 1 year after surgery, and asked questions about their SF-36 score, depression, and anxiety intensity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of life change in patients Undergoing Parathyroidectomy with end-stage renal failure | – | Other: Quality of life progression after parathyroidectomyQuality of Life Progression in Patients Undergoing Parathyroidectomy With Secondary Hyperparathyroidism Due to End-stage Renal Failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure will be invited to participate in this study.
Key inclusion criteria (2 listed)
- Age: ≥18 years old;
- Patients scheduled for parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure
Key exclusion criteria (1 listed)
- Patients refuse to participate
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 |
|---|---|---|
| Quality of life progression after parathyroidectomyStudy the progression of quality of life. | Other | Quality of life change in patients Undergoing Parathyroidectomy with end-stage renal failure |
Primary outcome
Measure quality of life scores change with respect to time
Time frame: up to 1 year
Quality of life will be assessed by the 36-Item short form health survey scale, Subjects complete one response from a range of options for each of the 36 questions. A combination of item response is then aggregated to calculate a score for each of the eight dimensions listed. The scores for each dimension range from 0 to 100, with higher scores indicating better health status
3 secondary outcomes
Measure anxiety and depression score change with respect to time
Time frame: up to 1 year
Measure bone pain scores change with respect to time
Time frame: up to 1 year
Length of hospital stay
Time frame: through study completion, an average of 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Secondary Hyperparathyroidism
RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
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.
Chunling Jiang contact
Chunling Jiang study director
West China Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Hyperparathyroidism and End Stage Renal Failure, run by Chunling Jiang.
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 2 inclusion and 1 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 23 Apr 2024. 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?
Contact Chunling Jiang, PhD (18980601096, jiangchunling@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure quality of life scores change with respect to time (time frame: up to 1 year). 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 23 Apr 2024.