RecruitingNAINTERVENTIONAL

Pilot Study "AHSP as a Biomarker of Sickle Cell Disease in a Population of Adults and Children"

This research study, called a 'pilot study', is investigating a protein known as AHSP. We are trying to find out if the amount of AHSP in a person's blood can act as a natural 'marker' to tell us more about sickle cell disease in both adults and children. It's not about testing a new medicine or treatment. Instead, we'll be looking at blood samples that are already taken as part of routine care for patients with sickle cell disease and comparing them to blood samples from people who don't have the condition. The aim is to see if AHSP levels change in a way that could help doctors understand the disease better in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier de Saint-Denis

Enrolment target

100

Start

06 Mar 2025

Estimated completion

20 Jan 2027

in Relation to Sickle Cell Disease

What is this study about?

This study is a research project focusing on sickle cell disease, a condition that affects red blood cells. Researchers are interested in a specific protein in the blood called AHSP (Alpha Haemoglobin Stabilizing Protein). The main goal is to see if the amount of AHSP in a person's blood can be a useful 'biomarker' for sickle cell disease. A biomarker is like a red flag or an indicator; it's something that can be measured to give doctors more information about a disease.

At the moment, this is a 'pilot study', which means it's an initial, smaller study to see if this idea has potential. It's not testing a new drug or treatment. Instead, it's about checking if AHSP levels differ in people with sickle cell disease compared to those who don't have it, and whether these levels relate to how the disease affects individuals. This kind of research is really important because finding new biomarkers can help doctors understand diseases better, potentially leading to improved ways to monitor or manage them in the future.

By comparing AHSP levels in adults and children with sickle cell disease to a group of people without the condition, scientists hope to learn if this protein could one day help in diagnosis, tracking disease progression, or even in evaluating new treatments. This step-by-step research is crucial for advancing our knowledge and ultimately aims to benefit patients.

Key takeaways

This study helps understand sickle cell disease better.
It checks levels of a protein called AHSP in blood.
No new treatments or medicines are involved.
Uses existing blood samples, no extra tests needed.
Your privacy is protected with coded samples.
Both children and adults with or without sickle cell disease can join.

Who may be eligible?

To be part of this study, you would either need to have sickle cell disease (specifically the SS or Sβ0 types) or be a healthy volunteer. For those with sickle cell disease, both adults (over 15 and a half years old) and children (between 3 and 15 and a half years old) can join.

Healthy volunteers, who do not have sickle cell disease, also need to be within the same age ranges. They would be people who are already having a blood test as part of their regular medical care for other reasons, such as for general health checks, certain blood conditions (but not sickle cell), or to investigate fevers or growth issues. We cannot include anyone who has had a blood transfusion in the last three months, has certain ongoing infections like hepatitis B or C or HIV, has active inflammation, or is taking steroid medicine by mouth.

Also, you can't have other serious health problems like active cancer, untreated thyroid problems, or be taking part in other treatment-based research studies. Your doctor will carefully check if you meet all the requirements, and if you are a minor, both parents would need to agree.

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.

Do you have sickle cell disease (SS or Sβ0) OR are you a healthy person having a routine blood test?
Are you between 3 and 15 and a half years old, or over 15 and a half?
Have you NOT had a blood transfusion in the last 3 months?
Do you NOT have infections like hepatitis B, C, or HIV active right now?
Are you NOT taking steroid tablets for a long time?
Are you NOT in another study that tests new treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it's quite straightforward as it doesn't involve any extra appointments or new medications. The researchers will use a small amount of blood from a sample that you're already giving for your usual medical care – so you won't need an extra needle stick. They will also collect some basic health information from your medical records.

From the blood sample, scientists will measure the AHSP protein level and also look at your genetic information related to sickle cell disease. Your sample will be stored safely at a very cold temperature (-80°C) and will be given a code to protect your privacy. This is a one-off assessment of your blood sample; there will be no follow-up visits specifically for this study. The total duration of your participation would simply be the point at which your blood sample is collected and analysed.

Potential risks and benefits

There are no direct medical benefits for you if you take part in this study, as it's purely for research and doesn't involve new treatments. However, your contribution will help doctors and scientists learn more about sickle cell disease, which could help others in the future. The risks of taking part are very low, as it only uses a small part of a blood sample you're already providing for your regular care, so there are no additional tests or side effects. Your personal information will be kept confidential. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Centre Hospitalier de Saint-Denis
Verified postcode
Saint-Denis, France· Recruiting

Common questions

What is AHSP?

AHSP is a protein in your blood that helps protect red blood cells. Researchers want to see if its levels are different in people with sickle cell disease.

Will I get a new medicine?

No, this study is not testing new medicines. It's only looking at blood samples to learn more about sickle cell disease.

Will I have extra blood tests?

No, the researchers will use a small part of a blood sample you are already giving for your usual check-ups.

Is my personal information safe?

Yes, your medical records and blood samples will be given a special code so your name isn't directly attached to them.

Can I leave the study if I change my mind?

Yes, you can decide to stop being part of the study at any time, and it won't affect your medical care.

How to find out more

Stéphanie NGO, Coordinating Investigator

stephanie.ngo@ch-stdenis.fr stephanie.ngo@ch-stdenis.fr Official trial record

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