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New french tool aims to measure how hyperparathyroidism affects daily life

NCT ID NCT06450431

Knowledge-focused Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aims to validate a French version of the Parathyroid Assessment of Symptoms (PAS) questionnaire for people with primary hyperparathyroidism. Researchers will ask 548 patients to fill out the PAS.fr and a standard quality-of-life questionnaire before and after surgery. The goal is to ensure the tool accurately measures how the condition and its treatment impact quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could provide a reliable French-language tool to measure how primary hyperparathyroidism affects quality of life and how surgery may help.
What could go wrong
This is an observational validation study, not a treatment trial. It does not test a new therapy, so it will not directly improve patient outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 548 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population was all patients consulting for PHPT in the surgery department at Nantes University Hospital during the study period: In order to study the discriminant validity and specificity of the PAS.fr for PHPT, a control group consisting of euthyroid patients undergoing thyroidectomy for thyroid nodules will also be included.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

primary hyperparathyroidism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Quality of life in primary hyperparathyroidism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nantes University Hospital

    RECRUITING

    Nantes, Loire-Atlantique, 44093, France