Ignite Creation Date:
2024-05-06 @ 2:47 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04428918
Status:
WITHDRAWN
Last Update Posted:
2020-09-22
First Post:
2020-06-11
Brief Title:
Biospecimen Procurement for Immunological Landscape Studies Following Hematopoietic Cell Transplantation
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Biospecimen Procurement for Immunological Landscape Studies Following Hematopoietic Cell Transplantation
Status:
WITHDRAWN
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was closed due to investigator discretion based on the lack of ability to recruit patients and research goals of the program
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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 andor 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
Detailed Description:
Background
Allogenic Hematopoietic Cell Transplantation HCT is a potentially curative option for some patients with primary immunodeficiencies PID and hematological cancers
HCT for PID looks to restore defects in cells of hematopoietic origin allowing for eradication of protracted or recurrent viral infections
The curative potential of allogenic HCT for hematologic malignancies is mediated by the allogeneic immune system through a graft-versus-tumor GVT effect
Characterization of the immunologic landscape in patients with successful eradication of viral infections and hematologic malignancies following allogenic HCT requires further investigation
Objectives
-To collect and bank blood apheresis products tumor body fluids and other biospecimens from patients with allogenic HCT and perform immunological landscape studies
Eligibility
-Patients age greater than or equal to 8 years of age and have undergone or are planning to undergo HCT
Design
Up to 100 subjects will be enrolled
Patients may undergo sampling of blood apheresis products tumor effusions ascites urine bone marrow skin mucosa saliva stool sputum spinal fluid or other tissues or fluids for banking and laboratory studies
No investigational or experimental therapy will be given as part of this protocol
Allogenic Hematopoietic Cell Transplantation HCT is a potentially curative option for some patients with primary immunodeficiencies PID and hematological cancers
HCT for PID looks to restore defects in cells of hematopoietic origin allowing for eradication of protracted or recurrent viral infections
The curative potential of allogenic HCT for hematologic malignancies is mediated by the allogeneic immune system through a graft-versus-tumor GVT effect
Characterization of the immunologic landscape in patients with successful eradication of viral infections and hematologic malignancies following allogenic HCT requires further investigation
Objectives
-To collect and bank blood apheresis products tumor body fluids and other biospecimens from patients with allogenic HCT and perform immunological landscape studies
Eligibility
-Patients age greater than or equal to 8 years of age and have undergone or are planning to undergo HCT
Design
Up to 100 subjects will be enrolled
Patients may undergo sampling of blood apheresis products tumor effusions ascites urine bone marrow skin mucosa saliva stool sputum spinal fluid or other tissues or fluids for banking and laboratory studies
No investigational or experimental therapy will be given as part of this protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20-C-0072 | None | None | None |