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NCT05791708 · ClinicalTrials.gov registry record
Cold Agglutinin Disease Real World Evidence Registry
A clinical trial of Cold Agglutinin Disease (CAD) and Cold Agglutinin Syndrome (CAS), sponsored by Recordati Group.
- Recruiting
- Registry status
- 400
- Enrollment target
- 20
- Study locations
NCT05791708: Recruiting study of Cold Agglutinin Disease (CAD) and Cold Agglutinin Syndrome (CAS), sponsored by Recordati Group.
NCT05791708 is a study of Cold Agglutinin Disease (CAD) and Cold Agglutinin Syndrome (CAS) that is actively recruiting participants, run by Recordati Group. The registered enrollment target is 400 participants. The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05791708, a study of Cold Agglutinin Disease (CAD) and Cold Agglutinin Syndrome (CAS), is actively recruiting participants, sponsored by Recordati Group.
- RECRUITING
- Registry status
- 400 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS). Among them, a minimum of 30 patients with CAD treated with sutimlimab are expected to take part in the sutimlimab cohort study. Patients with CAD who have been enrolled in previous sutimlimab clinical trials (e.g., BIVV009-01/LTS16214 \[NCT02502903,CAD patients\], BIVV009-03/EFC16215 \[NCT03347396\], and BIVV009-04/EFC16216 \[NCT03347422\]) and who either completed or discontinued the corresponding clinical trial are eligible to participate in the registry.
Primary Outcome
CAD or CAS characteristics at diagnosis, enrollment, and during follow up (e.g., criteria used for diagnosis, symptoms, laboratory results) will be described.
Conditions Studied
Interventions
- DRUG Sutimlimab
Study Locations (20)
New York
- 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
- Center for Blood Disorders Site Number : 1214 - New York
- SUNY Upstate Medical University Site Number : 1221 - Syracuse
California
- SLO Oncology and Hematology Site Number : 1235 - San Luis Obispo
- Mission Hope Medical Oncology Site Number : 1241 - Santa Maria
Ohio
- Cleveland Clinic Foundation Site Number : 1207 - Cleveland
- The Ohio State University Site Number : 1236 - Columbus
Alabama
- University of Alabama at Birmingham Site Number : 1230 - Birmingham
District of Columbia
- MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center Site Number : 1208 - Washington D.C.
Georgia
- Piedmont Cancer Institute, P.C Site Number : 1226 - Atlanta
Illinois
- Orchard Heathcare Research Inc. Site Number : 1202 - Skokie
Iowa
- Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Site Number : 1220 - Sioux City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2019-12-12 |
| Est. Completion | 2028-11-02 |
What NCT05791708 shows while recruiting
NCT05791708 is an observational study that tracks outcomes without assigning an intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap.
The record links to 2 conditions, with Cold Agglutinin Disease (CAD) appearing as the primary indexed condition, and to 1 intervention - of which Sutimlimab is the first listed.
NCT05791708 names 20 study sites across 16 states, led by New York, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT05791708 about?
NCT05791708 is a clinical study titled "Cold Agglutinin Disease Real World Evidence Registry". This is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS). Among them, a minimum of 30 patients with CAD treated with sutimlimab are expected to take p...
What is the current status of trial NCT05791708?
This trial is currently recruiting. The enrollment target is 400 participants. The study started on 2019-12-12. Estimated completion is 2028-11-02.
What conditions does trial NCT05791708 study?
This clinical trial studies the following conditions: Cold Agglutinin Disease (CAD), Cold Agglutinin Syndrome (CAS).
What interventions are being tested in trial NCT05791708?
The interventions under investigation include: Sutimlimab (DRUG).
Who is sponsoring clinical trial NCT05791708?
This trial is sponsored by Recordati Group, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05791708 being conducted?
This trial has 20 study locations across Alabama, California, District of Columbia, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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