RECRUITING

Cold Agglutinin Disease Real World Evidence Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Cold Agglutinin Disease Real World Evidence Registry

Quick Facts

Study Start:2019-12-12
Study Completion:2028-11-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05791708

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient aged ≥18 years
  2. 2. Patient able to understand the purpose of the study and who (or whose legally authorized representative) provided signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations
  3. 3. Patient with a diagnosis of CAD or CAS as per Investigator judgment based on the diagnosis criteria listed in study protocol
  1. 1. Patient with mixed warm and cold autoimmune hemolytic anemia, or warm autoimmune hemolytic anemia
  2. 2. Patient actively participating in a CAD or CAS interventional clinical trial. After a patient completes participation in said trial, he/she may be eligible for enrollment in this registry.

Contacts and Locations

Study Contact

Trial Transparency email recommended (Toll free number for US & Canada)
CONTACT
800-633-1610
Contact-US@sanofi.com

Principal Investigator

Clinical Sciences & Operations
STUDY_DIRECTOR
Sanofi

Study Locations (Sites)

University of Alabama at Birmingham Site Number : 1230
Birmingham, Alabama, 35205
United States
SLO Oncology and Hematology Site Number : 1235
San Luis Obispo, California, 93401
United States
Mission Hope Medical Oncology Site Number : 1241
Santa Maria, California, 93454
United States
MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center Site Number : 1208
Washington, District of Columbia, 20007
United States
Piedmont Cancer Institute, P.C Site Number : 1226
Atlanta, Georgia, 30290
United States
Orchard Heathcare Research Inc. Site Number : 1202
Skokie, Illinois, 60077
United States
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Site Number : 1220
Sioux City, Iowa, 51101
United States
Reliant Medical Group Site Number : 1205
Worcester, Massachusetts, 01608
United States
Henry Ford Hospital Site Number : 1232
Detroit, Michigan, 48202
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, New York, 11042
United States
Center for Blood Disorders Site Number : 1214
New York, New York, 10021
United States
SUNY Upstate Medical University Site Number : 1221
Syracuse, New York, 13210
United States
Brody School of Medicine at East Carolina University Site Number : 1203
Greenville, North Carolina, 27834
United States
Cleveland Clinic Foundation Site Number : 1207
Cleveland, Ohio, 44195
United States
The Ohio State University Site Number : 1236
Columbus, Ohio, 43210
United States
Hematology Oncology Associates, PC Site Number : 1211
Medford, Oregon, 97504
United States
University of Pittsburgh Medical Center-UPMC Hillman Cancer Center Site Number : 1210
Pittsburgh, Pennsylvania, 15232
United States
UT Medical Center Cancer Institute Site Number : 1237
Knoxville, Tennessee, 37920
United States
University of Washingtion Seattle Cancer Care Alliance Site Number : 1238
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Sanofi

  • Clinical Sciences & Operations, STUDY_DIRECTOR, Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-12
Study Completion Date2028-11-02

Study Record Updates

Study Start Date2019-12-12
Study Completion Date2028-11-02

Terms related to this study

Additional Relevant MeSH Terms

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