Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members

  • STATUS
    Recruiting
  • participants needed
    6000
  • sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
Updated on 24 June 2021
white blood cell count
treatment regimen
blood disorder
bone marrow procedure
leukapheresis
solid tumor
solid neoplasm
malignant solid neoplasm

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 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.

Description

The purpose of this protocol is to collect blood, bone marrow, urine, stool, oral samples, nasopharyngeal samples 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 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.

Details
Condition Hematologic Malignancy, Blood disorder, Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Cancer/Tumors, Healthy Volunteers, Peripheral Arterial Occlusive Disease, Ewing's Family Tumors, Brain Function, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Cancer (Pediatric), Metastatic Triple-Negative Breast Cancer, Blood Cancer, Neoplasms, Hematologic Cancer, Hematological Disorders, Hematologic Neoplasms, hematological malignancy, hematologic malignancies, hematological tumor, haematological malignancy, hematological malignancies
Clinical Study IdentifierNCT00071045
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last Modified on24 June 2021

Eligibility

Yes No Not Sure

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 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 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 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 Legally Authorized Representative (LAR) is able
to understand the investigational nature of the study and provide informed
consent after initial counseling by an AI. Separate consent forms for
interventional or surgical procedures will be obtained after explanation of
the specific procedure
Age 2 years and older (no upper limit)

Exclusion Criteria

Subjects or LAR unable to comprehend the investigational nature of the
protocol
Age less than 2 years
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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