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Recruiting NCT02964494

NCT02964494 The Congenital Dyserythropoietic Anemia Registry (CDAR)

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Clinical Trial Summary
NCT ID NCT02964494
Status Recruiting
Phase
Sponsor Children's Hospital Medical Center, Cincinnati
Condition Congenital Dyserythropoietic Anemia (CDA)
Study Type OBSERVATIONAL
Enrollment 10,000 participants
Start Date 2016-08-29
Primary Completion 2026-07

Eligibility & Interventions

Sex All sexes
Min Age N/A
Max Age N/A
Study Type OBSERVATIONAL

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 10,000 participants in total. It began in 2016-08-29 with a primary completion date of 2026-07.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The investigators have created and maintain a comprehensive registry for patients with the diagnosis of Congenital Dyserythropoietic Anemia (CDA) in North America. The goal of this registry is to collect long-term confidential data on patients with CDA in the US, Canada, and Mexico and maintain a bio-repository of de-identified patient blood and bone marrow specimens as a tool for the investigation of epidemiology, natural history, biology, and molecular pathogenetic mechanisms of CDA.

Eligibility Criteria

Inclusion Criteria: * Diagnosis of Congenital Dyserythropoietic Anemia (CDA), whether a genetic mutation is identified or not * Evidence of congenital anemia/jaundice or a positive family history * Evidence of ineffective erythropoiesis * Typical morphological appearance of bone marrow erythroblasts * All ages (ages 0-99) Exclusion Criteria: * Diagnosis of cancer * Myelodysplasia * Secondary dyserythropoiesis: e.g.; vitamin B12 deficiency or drug-related. Note1: Patients with rare band 3 (SLC4A1) mutations recently described to be associated with dyserythropoiesis will be eligible since the mechanisms appear to involve direct participation of band 3 in the erythroblast mitosis and cytokinesis. Note2: Siblings, parents, and family members of patients with confirmed CDA diagnosis are encouraged to participate in the study.

Contact & Investigator

Central Contact

Hotline

📞 513-636-6770

Principal Investigator

Theodosia Kalfa, MD, PhD

PRINCIPAL INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Frequently Asked Questions

Who can join the NCT02964494 clinical trial?

This trial is open to participants of all sexes, studying Congenital Dyserythropoietic Anemia (CDA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT02964494 currently recruiting?

Yes, NCT02964494 is actively recruiting participants. Visit ClinicalTrials.gov or contact Children's Hospital Medical Center, Cincinnati to inquire about joining.

Where is the NCT02964494 trial being conducted?

This trial is being conducted at Cincinnati, United States.

Who is sponsoring the NCT02964494 clinical trial?

NCT02964494 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Theodosia Kalfa, MD, PhD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 10,000 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology