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Biospecimen Procurement for Immunological Landscape Studies Following Hematopoietic Cell Transplantation

NCT04428918 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2020-09-22

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Christian S Hinrichs, M.D. · National Cancer Institute (NCI)

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-05
Primary Completion
2020-09-17
Completion
2020-09-17

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04428918 on ClinicalTrials.gov