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

NCT ID: NCT00071045

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 6000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-10-08

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 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.

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Detailed 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.

Conditions

Neoplasms; Hematologic Neoplasms; Healthy Volunteers

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

1

patients undergoing allogeneic stem cell transplantation

No interventions assigned to this group

2

HLA compatible donors

No interventions assigned to this group

Eligibility 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 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard W Childs, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Heart, Lung, and Blood Institute (NHLBI)

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Bretagne C Cowling, R.N.

Role: CONTACT

bretagne.cowling@nih.gov

(301) 827-3479

Richard W Childs, M.D.

Role: CONTACT

childsr@nhlbi.nih.gov

(301) 768-9433

Facility Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Role: primary

ccopr@nih.gov

800-411-1222 ext. TTY dial 711

References

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Reference Type: DERIVED

PMID: 33988272 (View on PubMed)

Giudice V, Feng X, Lin Z, Hu W, Zhang F, Qiao W, Ibanez MDPF, Rios O, Young NS. Deep sequencing and flow cytometric characterization of expanded effector memory CD8+CD57+ T cells frequently reveals T-cell receptor Vbeta oligoclonality and CDR3 homology in acquired aplastic anemia. Haematologica. 2018 May;103(5):759-769. doi: 10.3324/haematol.2017.176701. Epub 2018 Feb 1.

Reference Type: DERIVED

PMID: 29419434 (View on PubMed)

Aalbers AM, Kajigaya S, van den Heuvel-Eibrink MM, van der Velden VH, Calado RT, Young NS. Human telomere disease due to disruption of the CCAAT box of the TERC promoter. Blood. 2012 Mar 29;119(13):3060-3. doi: 10.1182/blood-2011-10-383182. Epub 2012 Feb 8.

Reference Type: DERIVED

PMID: 22323451 (View on PubMed)

El-Chemaly S, Ziegler SG, Calado RT, Wilson KA, Wu HP, Haughey M, Peterson NR, Young NS, Gahl WA, Moss J, Gochuico BR. Natural history of pulmonary fibrosis in two subjects with the same telomerase mutation. Chest. 2011 May;139(5):1203-1209. doi: 10.1378/chest.10-2048. Epub 2010 Oct 21.

Reference Type: DERIVED

PMID: 20966039 (View on PubMed)

Related Links

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2004-H-0012.html

NIH Clinical Center Detailed Web Page

Other Identifiers

04-H-0012

Identifier Type: -

Identifier Source: secondary_id

040012

Identifier Type: -

Identifier Source: org_study_id