RecruitingOBSERVATIONAL

Cohort Primary Hyperparathyroidism

This study, called CoHPT, is observing people with a common hormone problem known as primary hyperparathyroidism at Nantes University Hospital. This condition can affect calcium levels in the body. The main goal is to understand how a surgery called parathyroidectomy, which removes one or more parathyroid glands, impacts a person's health in the long term. Researchers want to see if surgery improves heart, kidney, and bone health, and how people feel overall (quality of life). They'll collect information from patients over several years, whether they have surgery or not. This will help doctors better decide who needs surgery and who can be safely monitored, and explain why certain choices are made for people with this condition.

At a glance

Status

Recruiting

Sponsor

Nantes University Hospital

Enrolment target

403

Start

31 Mar 2016

Estimated completion

24 Feb 2027

Primary Hyperparathyroidism

What is this study about?

This study focuses on a health problem called primary hyperparathyroidism. This happens when small glands in your neck, called parathyroid glands, make too much parathyroid hormone. This can make the calcium levels in your blood too high, which can affect your bones, kidneys, and even your heart. The main treatment for this condition is an operation called a parathyroidectomy, where the overactive gland is removed.

However, doctors aren't always sure if everyone with this condition needs surgery, especially those with milder forms. Some research suggests that people with mild primary hyperparathyroidism might be fine with just careful monitoring. This study wants to get a clearer picture of who truly benefits from surgery and who might be better off without it. They'll be looking at how surgery affects your overall health, including your heart, kidneys, and bones, and how it impacts your daily life and well-being.

During the study, researchers will collect health information and blood samples from participants over several years. This will help them understand the long-term effects of both having surgery and simply being monitored. They also hope to learn more about how primary hyperparathyroidism might affect the heart and find better ways to decide when surgery is the best option for patients.

Key takeaways

This study observes people with primary hyperparathyroidism.
It aims to understand the long-term effects of surgery (parathyroidectomy) versus observation.
Researchers will collect health data and blood samples over 5 years.
The goal is to improve decisions about who needs surgery and when.
It could help us understand how the condition affects heart, bone, and kidney health.
You won't receive new treatments or medicines in the study.

Who may be eligible?

To be part of this study, you must be 18 years old or older. The study is open to both men and women.

However, there are some reasons why you wouldn't be able to join. If you are under 18, pregnant, or breastfeeding, you cannot take part. Also, if you are an adult under formal guardianship (meaning someone else has legal responsibility for your decisions), you would not be able to join.

Finally, if your primary hyperparathyroidism is caused by another medical condition, or if you have a specific genetic condition called 'Multiple Endocrine Neoplasia,' this study is not suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you not pregnant or breastfeeding?
Are you able to make your own medical decisions?
Do you have primary hyperparathyroidism that is not caused by another specific condition?
Do you not have a genetic condition called 'Multiple Endocrine Neoplasia'?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't be given any new medication. Instead, the researchers will carefully observe your health over several years. You will have a thorough health check-up and blood tests when you first join the study. After that, you will have follow-up visits and assessments at 6 months, 1 year, 3 years, and 5 years later. These visits will involve updating your medical information and providing more blood samples. This helps the researchers understand how your health changes over time, whether you have surgery or not. The total duration of your participation could be up to 5 years.

Potential risks and benefits

Participating in this study might help improve understanding of primary hyperparathyroidism and its treatments, potentially benefiting future patients. However, there are no direct medical benefits for you personally from just being in the study, as it's an observational study, meaning you won't receive new treatments within the study. The main risks are those usually associated with regular doctor visits, such as the slight discomfort of blood tests. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Nantes University Hospital
Verified postcode
Nantes, France· Recruiting

Common questions

What is primary hyperparathyroidism?

It's a condition where tiny glands in your neck (parathyroid glands) make too much hormone, causing high calcium in your blood, which can affect your bones and kidneys.

What is parathyroidectomy?

It's a surgery to remove one or more of the parathyroid glands if they are overactive and causing your calcium levels to be too high.

Will I have to take new medicines if I join?

No, this study doesn't involve new medicines. It's about observing your health and regular care over time.

How long will I be in the study?

You could be followed for up to 5 years, with check-ups at specific times throughout this period.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Eric MIRALLIE, PHD

eric.mirallie@chu-nantes.fr 33 2 40 08 31 66 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.