Parathyroid Assessment of Symptoms French Version

NCT06450431 · tracked via the Priya Life Science France tracker

Sponsor

Nantes University Hospital

Phase

Observational

Started

2024-07-01

Last updated

2026-05-04

Condition(s) studied

Quality of Life in Primary Hyperparathyroidism

Investigational drug(s) / intervention(s)

SF-36 questionnaire French version and PAS.fr questionnaire

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.

Study 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. 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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).

Primary outcome measure(s)

Validate the unidimensionality of the PAS.fr for assessing quality of life in PHPT patients — 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.

Trial sites (1)

Facility	City	Region	Status
Nantes University Hospital	Nantes	Loire-Atlantique	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06450431 on ClinicalTrials.gov ↗ ← All trials in France