Prospective Cohort for the Evaluation of Biomarkers Following HCT (BMT CTN 1202)

Completed

Conditions studied: Allogeneic Hematopoietic Stem Cell Transplantation

In brief

The goal of this protocol is to establish a cohort of at least 1500 biologic samples collected prospectively from patients treated in BMT CTN centers that will be a shared bio specimen resource for conducting future allogeneic hematopoietic stem cell transplantation (HCT) correlative studies.

Key facts

Study ID

NCT01879072

Run by

Medical College of Wisconsin

People needed

1860

Starts

2013-06-01

Expected to finish

2016-09-01

Last updated by the study team

2022-12-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recipients of first allogeneic hematopoietic cell transplants that are transplanted in U.S. centers that participate in the NMDP/CIBMTR's "Protocol for a Research Sample Repository for Allogeneic Hematopoietic Stem Cell Transplantation and Marrow Toxic Injuries" and receive a cord blood graft or receive a bone marrow or peripheral blood graft from a related donor or from an unrelated donor in an NMDP-affiliated Donor Center or Registry participating in that same protocol.
• This transplant and donor center restriction is to allow linkage with pretransplant donor specimens collected under the NMDP/CIBMTR protocol. Current data indicate that >90% of donors approached under this protocol agree to provide samples
• Patients with any malignant or non-malignant hematologic disorder will be eligible for enrollment on this protocol. A subset of 240 sequential patients with acute leukemia in first or second remission will also provide research samples for gene expression studies.
• Children may participate in this study but must weigh at least 20 kilograms given the volume (100ml) and number of blood draws during this study. Subjects must weigh at least 30 kg to provide research samples for gene expression studies (additional 40 ml).
• All participants or parent/legal guardian must sign an informed consent for this study.
• Because studies using this resource will require linking with clinical data collected by CIBMTR, all participants or parent/legal guardian must also consent to participate in "Protocol for a Research Database for Hematopoietic Cell Transplantation and Marrow Toxic Injuries".

You may not qualify if…

• N/A

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• City of Hope National Medical Center — Duarte, California, United States
• Children's Hospital at Oakland — Oakland, California, United States
• University of CA, SF — San Francisco, California, United States
• Stanford Hospitals and Clinics — Stanford, California, United States
• Nemours/Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• University of Florida College of Medicine (Shands) — Gainesville, Florida, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Emory University — Atlanta, Georgia, United States
• BMT at Northside Hospital — Atlanta, Georgia, United States
• Ann and Robert H. Lurie Children's Hospital — Chicago, Illinois, United States
• University of Kansas Hospital — Kansas City, Kansas, United States
• Johns Hopkins — Baltimore, Maryland, United States
• DFCI/Brigham & Women's — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Washington University/Barnes Jewish Hospital — St Louis, Missouri, United States
• Washington University/St. Louis Children's Hospital — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Roswell Park — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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