Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450431
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-04
Brief Title:
Parathyroid Assessment of Symptoms French Version
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
French Validation of a Specific Tool for Quality of Life Evaluation in Primary Hyperparathyroidism
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAS_fr
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
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 JPasieka 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 PASfr 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 PASfr in a French population of patients with PHPT to evaluate their QoL impairment and the impact of surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-A00618-39 | OTHER | ANSM IDRCB | None |