RecruitingNAINTERVENTIONAL

Is Clonal Hematopoiesis of Indeterminate Potential Associated With Unprovoked Pulmonary Embolism?

This study is investigating a condition known as 'clonal hematopoiesis of indeterminate potential' (CHIP). CHIP is when some blood-forming cells have small changes, and it's been linked to other health issues in the past. Researchers are looking specifically at its connection to blood clots in the lungs, called pulmonary embolisms. Sometimes, these blood clots happen without a clear reason, and doctors call this 'unprovoked pulmonary embolism.' People with certain blood conditions, some of which are related to CHIP, are known to have a higher risk of blood clots. This study aims to find out if CHIP is more common in people who have had unprovoked pulmonary embolisms and if it helps explain why these clots occur. The study involves taking a blood sample to check for CHIP.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire, Amiens

Enrolment target

544

Start

01 Feb 2021

Estimated completion

01 Jan 2026

Pulmonary Embolism Hematopoiesis

What is this study about?

You might be reading this because you or someone you know has experienced a blood clot in the lung, known as a pulmonary embolism. Sometimes, these clots happen without a clear reason, and doctors call this an 'unprovoked pulmonary embolism.' This study is trying to understand more about why these unexplained clots occur.

The researchers are focusing on something called "clonal hematopoiesis of indeterminate potential," or CHIP for short. This is a condition where a small number of your blood-forming cells in the bone marrow have tiny genetic changes. These changes don't always cause problems, but they have been linked to an increased risk of certain health issues, including heart problems. Also, some conditions where blood cells multiply too much, which can be related to CHIP, are known to increase the risk of blood clots.

The main goal of this study is to see if CHIP is often found in people who have had an unprovoked pulmonary embolism. By finding out if there's a link, scientists hope to better understand the causes of these clots. This could eventually lead to better ways to prevent or treat them in the future. It's an important step in learning more about a complex medical issue.

Key takeaways

This study investigates why some lung blood clots happen without a clear cause.
It's looking at a condition called CHIP, which involves minor changes in blood cells.
Your participation would involve providing a single blood sample.
The study aims to improve understanding, potentially leading to better future treatments.
You must be between 18 and 65 years old and not have active cancer.
Taking part will not affect your existing medical care.

Who may be eligible?

To join this study, you must be between 18 and 65 years old. This study includes two groups of people: a 'case' group and a 'control' group.

The 'case' group will include people who have previously had a blood clot in the main arteries of their lungs (a proximal pulmonary embolism) that happened without a clear reason (unprovoked). You must also have had standard tests for blood clotting problems, and these tests came back negative.

The 'control' group will include people who have previously had a blood clot in the main arteries of their lungs (a proximal pulmonary embolism) that happened due to a clear reason (provoked), such as after surgery or a long plane trip. Like the case group, you must also have had standard tests for blood clotting problems, and these tests came back negative.

You cannot join this study if you are older than 65 or if you currently have cancer. If you're unsure if you fit these descriptions, it's always best to speak with your doctor or the research team.

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.

I am between 18 and 65 years old.
I have had a blood clot in my lungs (pulmonary embolism) in the past.
If my blood clot was unprovoked (no clear cause), I had negative clotting disorder tests.
If my blood clot was provoked (clear cause), I also had negative clotting disorder tests.
I do not currently have cancer.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your involvement will be quite straightforward. The main part of your participation will be providing a single blood sample. This blood sample will be used by the researchers to look for the genetic changes related to CHIP. There are no medications to take, extra visits to make, or long-term follow-up appointments directly related to this study. The total duration of your active participation will be very brief, essentially just the time it takes to have your blood drawn.

Potential risks and benefits

The main benefit of taking part in this study is that you would be contributing valuable information that could help doctors understand why some people develop unexplained blood clots in their lungs. This knowledge could eventually lead to better ways to identify those at risk or develop new treatments. The risks associated with this study are minimal, primarily those involved with a standard blood test, such as slight pain or bruising at the site where blood is drawn. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

CHU Amiens
Verified postcode
Amiens, France· Recruiting

Common questions

What is 'unprovoked pulmonary embolism'?

This is a blood clot in the lung that happens without a clear reason, like surgery, injury, or long-distance travel.

What is CHIP?

CHIP stands for 'clonal hematopoiesis of indeterminate potential.' It means some blood-forming cells have tiny genetic changes, but it doesn't always cause health problems.

Will I get my test results from the study?

The study aims to gather information for research purposes, so individual results may not be shared directly with participants. Discuss this with the research team if you have questions.

Do I need to change my current medication?

No, this study does not involve taking or changing any medication. It only requires a blood sample.

Is this study suitable for people with other health conditions?

The study has specific criteria. If you have any other health conditions, please discuss them with the research team to see if you are eligible.

How to find out more

Simon SOUDET, MD

soudet.simon@chu-amiens.fr 03 22 88 72 89 Official trial record

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