NCT06450431 Parathyroid Assessment of Symptoms French Version
| NCT ID | NCT06450431 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Quality of Life in Primary Hyperparathyroidism |
| Study Type | OBSERVATIONAL |
| Enrollment | 548 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 548 participants in total. It began in 2024-07-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06450431 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Quality of Life in Primary Hyperparathyroidism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06450431 currently recruiting?
Yes, NCT06450431 is actively recruiting participants. Contact the research team at Eric.mirallie@chu-nantes.fr for enrollment information.
Where is the NCT06450431 trial being conducted?
This trial is being conducted at Nantes, France.
Who is sponsoring the NCT06450431 clinical trial?
NCT06450431 is sponsored by Nantes University Hospital. The trial plans to enroll 548 participants.