Active not recruitingOBSERVATIONAL

Cold Agglutinin Disease Real World Evidence Registry

This study is like a large-scale collection of information about a rare blood condition called Cold Agglutinin Disease (CAD) or Cold Agglutinin Syndrome (CAS). It's designed to observe what happens to people with these conditions over time in their daily lives, rather than testing a new medicine. Researchers will gather details from many hospitals across different countries. Some people in the study will have already been treated with a medicine called sutimlimab in earlier research. By collecting this 'real-world evidence', doctors hope to gain a better understanding of how CAD affects people and how current treatments work outside of strict trial settings. This information could help improve care for CAD patients in the future.

At a glance

Status

Active not recruiting

Sponsor

RECORDATI GROUP

Enrolment target

429

Start

12 Dec 2019

Estimated completion

02 Nov 2028

Cold Agglutinin Disease (CAD)Cold Agglutinin Syndrome (CAS)

What is this study about?

Imagine a big health diary that collects information from many people with a rare blood condition called Cold Agglutinin Disease (CAD) or Cold Agglutinin Syndrome (CAS). That's essentially what this study is all about. It's not a trial to test a new medicine to see if it works; instead, it's a way for doctors and researchers to learn more about how these conditions affect people in their everyday lives over a long time.

CAD and CAS are conditions where your immune system mistakenly attacks and destroys your red blood cells, especially when you're cold. This can lead to anaemia, which makes you feel tired and weak. This study aims to gather detailed information about people's experiences, their symptoms, how their condition changes, and what treatments they receive.

A special part of this study will focus on people who have received a specific medicine called sutimlimab. By looking at information from many people, doctors hope to get a clearer picture of living with CAD or CAS, how common treatments work, and what challenges people face. This collected information could be really valuable for improving care for future patients.

Key takeaways

This study helps understand Cold Agglutinin Disease (CAD) better.
It collects real-world information, not testing new drugs.
Participation is observational, using your existing health records.
Some participants will have previously used sutimlimab.
The findings could improve future care for CAD patients.

Who may be eligible?

To join this study, you need to be at least 18 years old. You also need to fully understand what the study involves and sign a form giving your permission to take part and for your health information to be used, keeping your privacy in mind.

Importantly, a doctor must have already diagnosed you with Cold Agglutinin Disease (CAD) or Cold Agglutinin Syndrome (CAS). They will use specific guidelines to confirm this.

However, you cannot join if you have a different type of anaemia called 'mixed warm and cold autoimmune haemolytic anaemia' or 'warm autoimmune haemolytic anaemia'. Also, if you are currently taking part in another study that is testing a specific treatment for CAD or CAS, you won't be able to join this one until that other study is finished.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with Cold Agglutinin Disease (CAD) or Cold Agglutinin Syndrome (CAS) by a doctor?
Are you able to understand and sign a consent form?
Are you not currently in another study testing a treatment for CAD or CAS?
Do you not have a different type of anaemia called 'warm autoimmune haemolytic anaemia'?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

This study is an 'observational' study. This means you wouldn't be given new medicine or asked to follow a specific treatment plan for research. Instead, doctors would simply collect information about your health and treatment as it happens in your regular medical care over time. This information would come from your doctor's notes and any tests you already have as part of managing your CAD or CAS. There won't be any extra visits scheduled just for the study, nor will you receive any new medications through the study itself. The study aims to follow participants for a long time to understand the disease's progression and treatment effects in the real world.

Potential risks and benefits

The main benefit of joining this study is that the information collected could help doctors and researchers better understand Cold Agglutinin Disease and improve care for others in the future. As this is an observational study, you won't be given any new treatments, so there are no direct medication-related risks from the study itself. However, as with any study involving your health data, there's a small risk to your privacy, though strict measures are in place to protect your details. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (68)

University of Alabama at Birmingham Site Number : 1230
Birmingham, United States
SLO Oncology and Hematology Site Number : 1235
San Luis Obispo, United States
Mission Hope Medical Oncology Site Number : 1241
Santa Maria, United States
MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center Site Number : 1208
Washington D.C., United States
Piedmont Cancer Institute, P.C Site Number : 1226
Atlanta, United States
Orchard Heathcare Research Inc. Site Number : 1202
Skokie, United States
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Site Number : 1220
Sioux City, United States
Reliant Medical Group Site Number : 1205
Worcester, United States
Henry Ford Hospital Site Number : 1232
Detroit, United States
Northwell Health-Monter Cancer Center-North Shore University Hospital and Steven and Alexandra Cohen Children's Medical Center of New York (Schneider Children's Hospital)-North Shore Long Island Jewis Site Number : 1231
Lake Success, United States
Center for Blood Disorders Site Number : 1214
New York, United States
SUNY Upstate Medical University Site Number : 1221
Syracuse, United States

+56 more sites — see the official record for the full list.

Common questions

What is Cold Agglutinin Disease (CAD) or Syndrome (CAS)?

It's a rare blood condition where your immune system attacks your red blood cells, especially in cold temperatures, leading to anaemia.

Will I get a new medicine in this study?

No, this study is about observing your existing care; you won't be given new medicines through it.

How long will I be in the study?

The study is designed to follow people over a long period to understand the condition and treatments over time.

Will my information be kept private?

Yes, strict rules are in place to protect your personal health information and privacy.

What if I change my mind about participating?

You can leave the study at any time without it affecting your regular medical care.