|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00071045 |
Purpose
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:
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 subject's 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.
| Condition |
|---|
|
Neoplasms Hematologic Neoplasms |
| Study Type: | Observational |
| Official Title: | Collection of Blood, Bone Marrow, Urine, and/or Tissue Samples From Patients With Solid Tumors, Hematological Malignancies or Non-Malignant Hematologic Disorders or HLA Compatible Family Members |
| Study Start Date: | October 2003 |
The purpose of this protocol is to collect blood, bone marrow, urine, stool, buccal mucosa and/or 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 Hematology Branch 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.
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
The subject carries the diagnosis of malignant solid tumor or a malignant or non-malignant hematologic disorder, and is being screened at the NIH for eligibility for an NIH Clinical Center treatment protocol.
OR
The subject carries the diagnosis of malignant solid tumor or a malignant or non-malignant hematologic disorder, and is already enrolled on a clinical protocol at the NIH Clinical Center.
OR
The subject is a related HLA-compatible family member of a patient (bearing a diagnosis of malignant solid tumor or a malignant or non-malignant hematologic) being evaluated for or already enrolled on a clinical protocol at the NIH Clinical Center and is identified as a potentially suitable donor of allogeneic hematopoietic stem cells for transplantation.
OR
The subject carries the diagnosis of malignant solid tumor or a malignant or non malignant hematologic disorder or a bone marrow failure condition and is not available to participate in an NIH Clinical Center treatment protocol, or travel to the NIH clinical center, but is referred for participation through their home health care provider.
The subject or the subject's guardian is able to understand the investigational nature of the study and provide informed consent after initial counseling by clinical staff. Separate consent forms for all interventional or surgical procedures will be obtained after explanation of the specific procedure.
Age 2 years and older (no upper limit) when carrying the diagnosis of malignant solid tumor or a malignant or non-malignant hematologic disorder.
OR
Age 18 years and older if participating as an HLA compatible donor
EXCLUSION CRITERIA:
Subjects unable to comprehend the investigational nature of the procedure
Age less than 2 years (donors less than 18)
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Study ID Numbers: | 040012, 04-H-0012 |
| Study First Received: | October 9, 2003 |
| Last Updated: | March 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00071045 History of Changes |
| Health Authority: | United States: Federal Government |
|
Tissue Procurement Sample Collection Laboratory Research Tissue Sample |
Solid Tumor Blood Disorder HLA Donor |
|
Hematologic Neoplasms Hematologic Diseases |
|
Neoplasms Neoplasms by Site Hematologic Neoplasms Hematologic Diseases |
