Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071045
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2003-10-09
Brief Title:
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Collection of Blood Bone Marrow Urine andor Tissue Samples From Patients With Solid Tumors Hematological Malignancies or Non-Malignant Hematologic Disorders or HLA Compatible Family Members
Status:
RECRUITING
Status Verified Date:
2024-08-23
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will collect biological samples for use in research experiments aimed at better understanding the clinical features of certain diseases The specimens may be used to evaluate the effectiveness of known therapies refine treatment approaches identify potential new therapies and explore opportunities for disease prevention
The following individuals 2 years of age or older may be eligible for this study
Patients with a cancerous solid tumor or a cancerous or non-cancerous blood disorder who are being screened for or who are enrolled in a treatment study at the NIH Clinical Center
HLA-compatible donor family members 18 years of age or older of the above patients who are being evaluated for or are enrolled in an NIH study as a stem cell transplant donor
Patients with a cancerous solid tumor or a cancerous or non-cancerous blood disorder or a bone marrow failure condition who cannot participate in an NIH treatment protocol or travel to the NIH Clinical Center and who are referred for participation through their home health care provider
Research samples will be collected from participants when blood is drawn or bone marrow urine or stool is collected or tumor or other tissue is biopsied as part of their general medical care Investigators may periodically request an additional sample of blood stool or urine Participants who are 18 years of age or older may donate a large number of white blood cells through a procedure called leukapheresis This procedure is not part of general medical care and would be done for research purposes only For apheresis a catheter plastic tube is placed in a vein in the subjects arm Blood flows from the vein into a cell separator machine where the white cells are separated from the red cells platelets and plasma by a spinning process The white cells are removed and collected and the rest of the blood is returned to the subject through a second tube placed in the other arm
The following individuals 2 years of age or older may be eligible for this study
Patients with a cancerous solid tumor or a cancerous or non-cancerous blood disorder who are being screened for or who are enrolled in a treatment study at the NIH Clinical Center
HLA-compatible donor family members 18 years of age or older of the above patients who are being evaluated for or are enrolled in an NIH study as a stem cell transplant donor
Patients with a cancerous solid tumor or a cancerous or non-cancerous blood disorder or a bone marrow failure condition who cannot participate in an NIH treatment protocol or travel to the NIH Clinical Center and who are referred for participation through their home health care provider
Research samples will be collected from participants when blood is drawn or bone marrow urine or stool is collected or tumor or other tissue is biopsied as part of their general medical care Investigators may periodically request an additional sample of blood stool or urine Participants who are 18 years of age or older may donate a large number of white blood cells through a procedure called leukapheresis This procedure is not part of general medical care and would be done for research purposes only For apheresis a catheter plastic tube is placed in a vein in the subjects arm Blood flows from the vein into a cell separator machine where the white cells are separated from the red cells platelets and plasma by a spinning process The white cells are removed and collected and the rest of the blood is returned to the subject through a second tube placed in the other arm
Detailed Description:
The purpose of this protocol is to collect blood bone marrow urine stool oral samples nasopharyngeal samples andor both malignant and non-malignant tissue from patients who are either being evaluated for enrollment are consented to NIH Clinical Center treatment protocols or are receiving therapy for their disease through home health care providers Since a substantial proportion of the clinical and translational research in the NHLBI involves patients undergoing allogeneic stem cell transplantation this protocol will also be open to people identified as suitable HLA compatible donors for patients undergoing evaluation for or already enrolled in an allogeneic stem cell transplant protocol or receiving a stem cell transplant through their home health care providers These HLA compatible donors will serve as a source of peripheral blood mononuclear cells peripheral blood draws or leukapheresis for use in evaluating allogeneic graft versus host and graft-versus-tumor effects
The primary objective is to provide a mechanism for collection tracking storing dispensing analyzing and disposing of these laboratory research samples from patients and HLA matched donors
There is no primary endpoint
The primary objective is to provide a mechanism for collection tracking storing dispensing analyzing and disposing of these laboratory research samples from patients and HLA matched donors
There is no primary endpoint
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 04-H-0012 | None | None | None |