Biospecimen Procurement for Immunological Landscape Studies Following Hematopoietic Cell Transplantation

NCT04428918 | Withdrawn

• 2 other identifiers: 20007220-C-0072
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Hematopoietic Stem Cell Transplantation; Cell Transplantation; Hematologic Malignancies

Keywords

Immunological; Apheresis Products; Protein

Outcome Measures

Primary Outcomes (1)

• Sample Aquisition

  To conduct immunological landscape studies on samples collected. To collect and bank blood, apheresis products, tumor, body fluids, and other biospecimens from patients with allogenic HCT.

  Ongoing

Study Arms (1)

Cohort 1

Allogeneic HCT recipient or patient pending receipt of HCT

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients age \> 8 years of age and have undergone or are planning to undergo HCT. Participants are selected from other NIH protocols (including screening protocols) they may be co-enrolled on and can include both inpatient and outpatient.

You may qualify if:

• Diagnosis of a hematologic malignancy, immunodeficiency or disorder of T-cell proliferation and/or dysregulation
• Have undergone or planning to undergo an allogenic hematopoietic cell transplantation
• Age greater than or equal to 8 years
• Hemoglobin greater than or equal to 8 mg/dL and platelet count \> 75 K/uL
• Weight greater than or equal to 48 kg
• Adequate venous access

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)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Christian S Hinrichs, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 11, 2020
• Study Start: June 5, 2020
• Primary Completion: September 17, 2020
• Study Completion: September 17, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Locations

US (1)