Parathyroid Assessment of Symptoms French Version (PAS_fr)

April 28, 2026 updated by: Nantes University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
548

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Recruiting
        • Nantes university hospital
        • Contact:
        • Principal Investigator:
          • Eric MIRALLIE, PHD
        • Sub-Investigator:
          • Samuel Frey, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. 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).

  2. Control Patients

    • 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).

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control group
Patients attempting surgical consultation for thyroid nodule, with no history of PHPT.
Other: SF-36 questionnaire French version and PAS.fr questionnaire
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.
PHPT before surgery group
Patients attempting surgical consultation for PHPT.
Other: SF-36 questionnaire French version and PAS.fr questionnaire
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.
PHPT 6 months after surgery group
Patients operated for PHPT interrogated 6 months after surgery
Other: SF-36 questionnaire French version and PAS.fr questionnaire
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.
PHPT 12 months after surgery group
Patients operated for PHPT interrogated 12 months after surgery
Other: SF-36 questionnaire French version and PAS.fr questionnaire
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.
PHPT 36 months after surgery group
Patients operated for PHPT interrogated 36 months after surgery
Other: SF-36 questionnaire French version and PAS.fr questionnaire
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reliability of the PAS.fr score
Time Frame: 4 weeks
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.
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
Content validity: qualitative validation by the author of the original PAS questionnaire after back-translation of the PAS.fr questionnaire.
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 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.
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 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)).
4 weeks
Discriminant validity to show that the PAS.fr score can distinguish HPT1 patients with different clinical manifestations
Time Frame: 4 weeks
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.
4 weeks
Concurrent validation with the SF-36 questionnaire - Reproducibility in stable patients over a period of 15 days
Time Frame: 4 weeks
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).
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC24_0151
  • 2024-A00618-39 (Other Identifier: ANSM (IDRCB))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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