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

NCT00071045 | Recruiting

• 2 other identifiers: 04001204-H-0012
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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. ...

Conditions

Healthy Volunteers; Neoplasms; Hematologic Neoplasms

Keywords

Tissue Procurement; Sample Collection; Laboratory Research Specimens; Natural History

Outcome Measures

Primary Outcomes (1)

• Biospecimen storage

  Biospecimen storage

  onging

Study Arms (2)

1

patients undergoing allogeneic stem cell transplantation

2

HLA compatible donors

Eligibility Criteria

• Age: 2 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subject carries the diagnosis of malignant solid tumor or a malignant or non-malignant hematologic disorder; carries the diagnosis of malignant solid tumor or a malignant or non-malignant hematologic disorder; is a HLA-compatible family member of a patient (bearing a diagnosis of malignant solid tumor or a malignant or non-malignant hematologic disorder) 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; 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.

You may qualify if:

• 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.
• 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.
• 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.
• 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)

You may not qualify if:

• Subjects or LAR unable to comprehend the investigational nature of the protocol.
• Age less than 2 years

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (4)

• Watanabe N, Gao S, Wu Z, Batchu S, Kajigaya S, Diamond C, Alemu L, Raffo DQ, Hoffmann P, Stone D, Ombrello AK, Young NS. Analysis of deficiency of adenosine deaminase 2 pathogenesis based on single-cell RNA sequencing of monocytes. J Leukoc Biol. 2021 Sep;110(3):409-424. doi: 10.1002/JLB.3HI0220-119RR. Epub 2021 May 14.

  PMID: 33988272 DERIVED

• 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.

  PMID: 29419434 DERIVED

• 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.

  PMID: 22323451 DERIVED

• 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.

  PMID: 20966039 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Richard W Childs, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bretagne C Cowling, R.N.

CONTACT

(301) 827-3479; bretagne.cowling@nih.gov

Richard W Childs, M.D.

CONTACT

(301) 768-9433; childsr@nhlbi.nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2003
• First Posted: October 10, 2003
• Study Start: October 8, 2003
• Last Updated: June 5, 2026

Record last verified: 2026-06-02

Locations

US (1)