Validation of a French questionnaire for assessing quality of life in primary hyperparathyroidism

French Validation of a Specific Tool for Quality of Life Evaluation in Primary Hyperparathyroidism

This study is testing a French questionnaire to see how primary hyperparathyroidism affects the quality of life for patients, including those who have had surgery and those who haven't.

Quick facts

• Study type: Observational
• Enrollment: 548 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nantes University Hospital (Academic / other)
• Locations: 1 site (Nantes, Loire-Atlantique)
• Trial ID: NCT06450431 on ClinicalTrials.gov

What this trial studies

This observational study aims to validate the French version of the Parathyroid Assessment of Symptoms (PAS) questionnaire to evaluate quality of life (QoL) impairment in patients with primary hyperparathyroidism (PHPT). The study will include both operated and non-operated patients with PHPT, as well as a control group of patients undergoing thyroid surgery for benign conditions. By utilizing a specific tool designed for PHPT-related QoL assessment, the study seeks to provide a clearer understanding of the impact of surgery on patient outcomes. The PAS.fr questionnaire will be administered alongside the SF-36 questionnaire to gather comprehensive data on QoL.

Who should consider this trial

Good fit: Ideal candidates include adult patients diagnosed with primary hyperparathyroidism, whether they have undergone surgery or not.

Not a fit: Patients with normal calcium levels and no hyperparathyroidism will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a validated tool for assessing QoL in PHPT patients, leading to better-informed treatment decisions and improved patient outcomes.

How similar studies have performed: While there have been studies assessing QoL in PHPT, this specific approach using a validated French questionnaire is novel and has not been previously tested.

Eligibility criteria

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).

Where this trial is running

Nantes, Loire-Atlantique

• Nantes University Hospital — Nantes, Loire-Atlantique, France (Recruiting)

Study contacts

• Study coordinator: Eric MIRALLIE

Conditions Quality of Life in Primary Hyperparathyroidism; Primary hyperparathyroidism; Parathyroidectomy; Quality of life