Biospecimen Procurement for Immunological Landscape Studies Following Hematopoietic Cell Transplantation

Withdrawn before enrolling

Conditions studied: Hematopoietic Stem Cell Transplantation, Cell Transplantation, Hematologic Malignancies

In brief

Background: Allogenic hematopoietic cell transplantation (HCT) is a procedure in which a person gets stem cells from a donor in order to treat their disease. Researchers want to collect samples from people who have had or will have HCT. They will perform tests on the samples to study the immune system and its response to infections and disease. Objective: To collect biological samples from people who have had or are planning to have HCT to treat primary immunodeficiencies, blood cancers, or disorders of T-cell proliferation and/or dysregulation. Eligibility: People age 8 years and older who have undergone or are planning to undergo HCT. Design: Participants will be screened with: Medical history Medical chart review Physical exam Blood tests. Participants may give blood and urine samples. Participants may have a skin biopsy. Participants may undergo apheresis. For this, a needle will be placed into an arm vein to take blood. A machine divides the whole blood into parts. The sample cells are taken out and the rest of the blood is returned through a second needle in the other arm. Participants may have a bone marrow aspiration and biopsy. For this, the hipbone will be numbed. A needle will be put into the hipbone. Bone marrow will be taken out through the needle. Participants may have a tumor or other abnormal tissue biopsy. For this, a tissue sample is obtained using a needle and syringe. They will sign a separate consent form. They may have a body scan or ultrasound to help locate the tumor during the biopsy. Participation lasts for as long as participants choose to give samples.

Key facts

Study ID

NCT04428918

Run by

National Cancer Institute (NCI)

People needed

0

Starts

2020-06-05

Expected to finish

2020-09-17

Last updated by the study team

2020-09-22

Who can join

Age: 8 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Active concomitant medical or psychological illnesses that may increase the risk to the subject
• Inability of subject or parent/legal guardian to provide informed consent
• Pregnant or breastfeeding women as some tests and procedures allowed are contraindicated in pregnancy (i.e., CT scans, administration of iodinated contrast)

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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