Quality of Life in Primary HyperparathyroidismPAS_frNCT06450431
Parathyroid Assessment of Symptoms French Version
An observational study of Quality of Life in Primary Hyperparathyroidism, run by Nantes University Hospital at 1 site in France.
Trial summary
Primary hyperparathyroidism has been associated with an impaired quality of life. Surgery has been suggested to improve this outcome in patients with baseline quality of life impairment; however, few studies have used specific tool for quality of life assessment this pathology, none being validated in French version. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life in Primary Hyperparathyroidism
- What is being tested?
- SF-36 questionnaire French version and PAS.fr questionnaire
- How many people
- 548 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2024to 1 Aug 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population was all patients consulting for PHPT in the surgery department at Nantes University Hospital during the study period: In order to study the discriminant validity and specificity of the PAS.fr for PHPT, a control group consisting of euthyroid patients undergoing thyroidectomy for thyroid nodules will also be included.
Who may be able to join
- Patients with PHPT
- Adult patients
- Patients with PHPT, whether operated on or not, defined by a calcium level > 2.60 mmol/L with inappropriate PTH (> 15 pg/mL) or normal calcium with elevated PTH (> 65 pg/mL) before surgery.
- Consulting for PHPT surgery, or at 6, 12, or 36 months post-surgery.
- Not opposed to participating in the study (questionnaires will be provided/sent with the study information sheet. If the patient returns the questionnaires, it will be considered that they are not opposed to participating in the study).
- Control Patients
Show all 9Show fewer
- Adult patients
- Patients consulting for thyroid surgery for benign thyroid nodules with normal thyroid function (serum TSH between 0.4 and 4.0 mIU/L) and no hypercalcemia (calcium ≤ 2.6 mmol/L), or seen in post-operative consultation following a cholecystectomy or appendectomy for simple appendicitis, who have not experienced post-operative complications
- Not opposed to participating in the study (questionnaires will be provided/sent with the study information sheet. If the patient returns the questionnaires, it will be considered that they are not opposed to participating in the study).
Who cannot join
- Pregnant women at the time of completing the questionnaires (the child's parathyroid glands can influence the mother's parathyroid status).
- Minors or protected patients (under guardianship/curatorship).
- Patients with secondary/tertiary hyperparathyroidism (defined by hypocalcemia < 2.0 mmol/L with elevated PTH, or hypercalcemia with elevated PTH with a history of kidney transplantation, respectively).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, Loire-Atlantique, 44093
Eric MIRALLIE, PHD, 33 2 40 08 30 22, eric.mirallie@chu-nantes.fr
Eric MIRALLIE, PHD
About this study
Official title: French Validation of a Specific Tool for Quality of Life Evaluation in Primary Hyperparathyroidism
Primary hyperparathyroidism has been associated with an impaired quality of life. Surgery has been suggested to improve this outcome in patients with baseline quality of life impairment; however, few studies have used specific tool for quality of life assessment this pathology, none being validated in French version. The aim of this study is to validate the parathyroid assessment of symptoms (PAS) questionnaire in French language to evaluate quality of life impairment and the impact of surgery in patients with primary hyperparathyroidism.
Read the detailed description
Besides classic target organs of primary hyperparathyroidism (PHPT) that are the bone and kidneys, patients also present with non-specific and neurocognitive symptoms that impair quality of life (QoL). Several studies have assessed QoL in these patients and the impact of surgery, but using varied tools for QoL evaluation. While observational studies strongly suggest symptoms and QoL improvement after surgery, randomized studies with fewer included patients showed milder results. Therefore, international guidelines have not accepted QoL impairment as an indication for surgery. The reasons of these discrepancies between studies include the use of varied tools to evaluate QoL, either specific or not for this pathology. Using a specific tool for PHPT-related QoL could be more appropriate to understand the impact of surgery; however, no such questionnaire has been validated in French version up today. A specific questionnaire named the parathyroid assessment of symptoms (PAS) has been proposed by the team of J.Pasieka several years ago and has been demonstrated to specifically describe QoL impairment in PHPT based on 13 frequent non-specific symptoms. For the present study, a French version of the PAS (PAS.fr) have been created by double translation followed by a backtranslation that has been validated by the author of the original questionnaire. The aim of this study is to validate the use of PAS.fr in a French population of patients with PHPT to evaluate their QoL impairment and the impact of surgery.
- Being tested
- SF-36 questionnaire French version and PAS.fr questionnaire
- Keywords
- Primary hyperparathyroidism, Parathyroidectomy, Quality of life
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SF-36 questionnaire French version and PAS.fr questionnaireOther
Patients will receive both the SF-36 questionnaire (control generic questionnaire for QoL evaluation validated in French language) and the PAS.fr questionnaire at the designated time (before surgery, 6, 12 or 36 months after surgery) during the consultation, or by mail. For concurrent validation of the PAS.fr questionnaire, a second questionnaire will be sent to the patients 2-4 weeks thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Patients attempting surgical consultation for thyroid nodule, with no history of PHPT. Receives: Other: SF-36 questionnaire French version and PAS.fr questionnaire | |
| PHPT before surgery group | Patients attempting surgical consultation for PHPT. Receives: Other: SF-36 questionnaire French version and PAS.fr questionnaire | |
| PHPT 6 months after surgery group | Patients operated for PHPT interrogated 6 months after surgery Receives: Other: SF-36 questionnaire French version and PAS.fr questionnaire | |
| PHPT 12 months after surgery group | Patients operated for PHPT interrogated 12 months after surgery Receives: Other: SF-36 questionnaire French version and PAS.fr questionnaire | |
| PHPT 36 months after surgery group | Patients operated for PHPT interrogated 36 months after surgery Receives: Other: SF-36 questionnaire French version and PAS.fr questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate the unidimensionality of the PAS.fr for assessing quality of life in PHPT patients
The unidimensionality of the 13 items of the PAS.fr questionnaire will be determined based on their suitability for a confirmatory factor analysis (CFA). Suitability will be judged based on the suitability coefficients RMSEA, TLI and CFI. The adequation will be judged acceptable if RMSEA<0.08, CFI>0.9 and TLI>0.9 and will be judged good if RMSEA<0.05, CFI>0.95 and TLI>0.95.
Measured: 4 weeks
Secondary outcomes (6)
Reliability of the PAS.fr score
Reliability measured by Cronbach's alpha coefficient and McDonald's Omega coefficient. Reliability will be considered acceptable if these coefficients are greater than 0.7 and good if they are greater than 0.8.
Measured: 4 weeks
Content validity to demonstrate the relevance of the French translation compared to the original version of the PAS.fr
Content validity: qualitative validation by the author of the original PAS questionnaire after back-translation of the PAS.fr questionnaire.
Measured: 4 weeks
Discriminant validity to show that the PAS.fr score is significantly correlated with biological values impacted by PHPT and specific to PHPT
Discriminant validation: Spearman correlation between the PAS.fr score and measurements of PTH, calcium, and urinary calcium. Moderate to strong correlations (>0.4) are expected between these values.
Measured: 4 weeks
Discriminant validity by comparing PAS.fr scores to those of a control population of patients who do not have PHPT
Discriminant validation: ANOVA to show differences in PAS.fr scores between HPT1 patients and other patients (control group consisting of patients consulting for thyroidectomy for thyroid nodule (euthyroid)).
Measured: 4 weeks
Discriminant validity to show that the PAS.fr score can distinguish HPT1 patients with different clinical manifestations
Discriminant validation: ANOVA to show differences in the mean PAS.fr scores between a group of HPT1 patients with clinical manifestations (bone involvement defined by the presence of fractures and/or a T-score < -2.5 on bone densitometry and renal involvement defined by the presence of kidney stones < 10 years and/or a glomerular filtration rate < 60 mL/min) and other patients.
Measured: 4 weeks
Concurrent validation with the SF-36 questionnaire - Reproducibility in stable patients over a period of 15 days
Concurrent validation: Spearman correlation coefficients between the PAS.fr score and SF-36 quality of life scores. Weak to moderate positive correlations (>0.2) are expected. - Reproducibility: Intraclass correlation coefficients between PAS.fr scores obtained from two closely timed administrations of the questionnaire (2-3 weeks apart).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Jul 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Life in Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Nantes University 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 548 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450431
- Sponsor's protocol ID
- RC24_0151
- Other IDs
- 2024-A00618-39
- Acronym
- PAS_fr
- Status last verified
- Apr 2026
- First submitted
- 4 Jun 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- 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 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Validation of a Specific Tool for Quality of Life Evaluation in Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT06450431
- Acronym / sponsor ID
- PAS_fr / RC24_0151
- Keywords
- Primary hyperparathyroidism, Parathyroidectomy, Quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 548 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 10 Jun 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.
Primary hyperparathyroidism has been associated with an impaired quality of life. Surgery has been suggested to improve this outcome in patients with baseline quality of life impairment; however, few studies have used specific tool for quality of life assessment this pathology, none being validated in French version. The aim of this study is to validate the parathyroid assessment of symptoms (PAS) questionnaire in French language to evaluate quality of life impairment and the impact of surgery in patients with primary hyperparathyroidism.
Detailed description
Besides classic target organs of primary hyperparathyroidism (PHPT) that are the bone and kidneys, patients also present with non-specific and neurocognitive symptoms that impair quality of life (QoL). Several studies have assessed QoL in these patients and the impact of surgery, but using varied tools for QoL evaluation. While observational studies strongly suggest symptoms and QoL improvement after surgery, randomized studies with fewer included patients showed milder results. Therefore, international guidelines have not accepted QoL impairment as an indication for surgery. The reasons of these discrepancies between studies include the use of varied tools to evaluate QoL, either specific or not for this pathology. Using a specific tool for PHPT-related QoL could be more appropriate to understand the impact of surgery; however, no such questionnaire has been validated in French version up today. A specific questionnaire named the parathyroid assessment of symptoms (PAS) has been proposed by the team of J.Pasieka several years ago and has been demonstrated to specifically describe QoL impairment in PHPT based on 13 frequent non-specific symptoms. For the present study, a French version of the PAS (PAS.fr) have been created by double translation followed by a backtranslation that has been validated by the author of the original questionnaire. The aim of this study is to validate the use of PAS.fr in a French population of patients with PHPT to evaluate their QoL impairment and the impact of surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: SF-36 questionnaire French version and PAS.fr questionnairePatients attempting surgical consultation for thyroid nodule, with no history of PHPT. |
| PHPT before surgery group | – | Other: SF-36 questionnaire French version and PAS.fr questionnairePatients attempting surgical consultation for PHPT. |
| PHPT 6 months after surgery group | – | Other: SF-36 questionnaire French version and PAS.fr questionnairePatients operated for PHPT interrogated 6 months after surgery |
| PHPT 12 months after surgery group | – | Other: SF-36 questionnaire French version and PAS.fr questionnairePatients operated for PHPT interrogated 12 months after surgery |
| PHPT 36 months after surgery group | – | Other: SF-36 questionnaire French version and PAS.fr questionnairePatients operated for PHPT interrogated 36 months after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population was all patients consulting for PHPT in the surgery department at Nantes University Hospital during the study period: In order to study the discriminant validity and specificity of the PAS.fr for PHPT, a control group consisting of euthyroid patients undergoing thyroidectomy for thyroid nodules will also be included.
Key inclusion criteria (9 listed)
- Patients with PHPT
- Control Patients
Key exclusion criteria (3 listed)
- Pregnant women at the time of completing the questionnaires (the child's parathyroid glands can influence the mother's parathyroid status).
- Minors or protected patients (under guardianship/curatorship).
- Patients with secondary/tertiary hyperparathyroidism (defined by hypocalcemia < 2.0 mmol/L with elevated PTH, or hypercalcemia with elevated PTH with a history of kidney transplantation, respectively).
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 |
|---|---|---|
| SF-36 questionnaire French version and PAS.fr questionnairePatients will receive both the SF-36 questionnaire (control generic questionnaire for QoL evaluation validated in French language) and the PAS.fr questionnaire at the designated time (before surgery, 6, 12 or 36 months after surgery) during the consultation, or by mail. For concurrent validation of the PAS.fr questionnaire, a second questionnaire will be sent to the patients 2-4 weeks thereafter. | Other | Control group, PHPT 12 months after surgery group, PHPT 36 months after surgery group, PHPT 6 months after surgery group, PHPT before surgery group |
Primary outcome
Validate the unidimensionality of the PAS.fr for assessing quality of life in PHPT patients
Time frame: 4 weeks
The unidimensionality of the 13 items of the PAS.fr questionnaire will be determined based on their suitability for a confirmatory factor analysis (CFA). Suitability will be judged based on the suitability coefficients RMSEA, TLI and CFI. The adequation will be judged acceptable if RMSEA<0.08, CFI>0.9 and TLI>0.9 and will be judged good if RMSEA<0.05, CFI>0.95 and TLI>0.95.
6 secondary outcomes
Reliability of the PAS.fr score
Time frame: 4 weeks
Content validity to demonstrate the relevance of the French translation compared to the original version of the PAS.fr
Time frame: 4 weeks
Discriminant validity to show that the PAS.fr score is significantly correlated with biological values impacted by PHPT and specific to PHPT
Time frame: 4 weeks
Discriminant validity by comparing PAS.fr scores to those of a control population of patients who do not have PHPT
Time frame: 4 weeks
Discriminant validity to show that the PAS.fr score can distinguish HPT1 patients with different clinical manifestations
Time frame: 4 weeks
Concurrent validation with the SF-36 questionnaire - Reproducibility in stable patients over a period of 15 days
Time frame: 4 weeks
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 4 May 2026.
- Individual participant dataSharing planned: Undecided
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.
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 Quality of Life in Primary Hyperparathyroidism, run by Nantes University Hospital at 1 site in France.
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 9 inclusion and 3 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 4 May 2026. 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 France. 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 Eric MIRALLIE (02.40.08.30.22, Eric.mirallie@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate the unidimensionality of the PAS.fr for assessing quality of life in PHPT patients (time frame: 4 weeks). 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 4 May 2026.