Parathyroid Assessment of Symptoms French Version
French Validation of a Specific Tool for Quality of Life Evaluation in Primary Hyperparathyroidism
Nantes University Hospital
750 participants
Jun 15, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria9
- 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
- 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).
- 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 Criteria3
- 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).
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06450431