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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


N/A
2 Years
N/A
Open (Enrolling)
Both
Neoplasms, Hematologic Neoplasms

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Trial Information

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


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.

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.

Inclusion Criteria


- INCLUSION CRITERIA:

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)

EXCLUSION CRITERIA:

Subjects unable to comprehend the investigational nature of the procedure

Age less than 2 years

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Richard W Childs, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Heart, Lung, and Blood Institute (NHLBI)

Authority:

United States: Federal Government

Study ID:

040012

NCT ID:

NCT00071045

Start Date:

October 2003

Completion Date:

Related Keywords:

  • Neoplasms
  • Hematologic Neoplasms
  • Tissue Procurement
  • Sample Collection
  • Laboratory Research
  • Tissue Sample
  • Solid Tumor
  • Blood Disorder
  • HLA Donor
  • Neoplasms
  • Hematologic Diseases
  • Hematologic Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892