NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Natural History Study of the Complications Associated with Allogeneic Hematopoietic Stem Cell Transplantations

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-I-0177

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 2
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

None

Keywords

Post-Transplant Infection;
Post-Transplant Bacteremia;
Post-Transplant Virus;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Post-Transplant Infections;
Post-Transplant Renal Insufficiency;
Post-Transplant Pulmonary Complications

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

Background:

- The National Institutes of Health (NIH) performs up to 100 allogenic stem cell transplants (allo-HSCT) each year. Many studies already look at different problems that can follow a transplant. But there are many types of transplants, diseases, responses, and treatments. An organized study of this information could help researchers learn more about how often transplant complications occur and what problems they cause. It could also lead to ideas for future research. This study will focus on complications thought to be the most significant.

Objectives:

- To gather information on the complications that may occur after an allo-HSCT.

Eligibility:

- People over 2 years of age currently enrolled in an allo-HSCT study at NIH.

Design:

- Visits for this study will be scheduled along with primary study visits. The number of visits will depend on the primary study schedule.

- At each visit, participants will answer questions and take physical exams.

- The same questions and physical exams will continue for as long as they are in the primary study.

- In between visits, researchers might call participants to discuss their health. They may also discuss the cases with the primary study doctors and other doctors. Primary transplant study doctors will make treatment decisions.

- When participation in the primary transplant study ends, participation in this study will also end.

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Eligibility

INCLUSION CRITERIA:

Subjects over the age of 2 that are actively enrolled in an allo-HSCT protocol at any NIH institute will be eligible to participate in this study regardless of gender or medical condition. Patients may be consented prior to and up to a week after receiving the stem cells (Day 0 of transplant).

EXCLUSION CRITERIA:

Subjects with any condition that, in the opinion of the investigator, contraindicates participation in the study will be excluded.


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Citations:

De Pauw B, Walsh TJ, Donnelly JP, Stevens DA, Edwards JE, Calandra T, Pappas PG, Maertens J, Lortholary O, Kauffman CA, Denning DW, Patterson TF, Maschmeyer G, Bille J, Dismukes WE, Herbrecht R, Hope WW, Kibbler CC, Kullberg BJ, Marr KA, Mu(SqrRoot) oz P, Odds FC, Perfect JR, Restrepo A, Ruhnke M, Segal BH, Sobel JD, Sorrell TC, Viscoli C, Wingard JR, Zaoutis T, Bennett JE; European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group; National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Clin Infect Dis. 2008 Jun 15;46(12):1813-21

Seo S, Campbell AP, Xie H, Chien JW, Leisenring WM, Englund JA, Boeckh M. Outcome of respiratory syncytial virus lower respiratory tract disease in hematopoietic cell transplant recipients receiving aerosolized ribavirin: significance of stem cell source and oxygen requirement. Biol Blood Marrow Transplant. 2013 Apr;19(4):589-96. doi: 10.1016/j.bbmt.2012.12.019. Epub 2013 Jan 5.

Azoulay E, Bergeron A, Chevret S, Bele N, Schlemmer B, Menotti J. Polymerase chain reaction for diagnosing pneumocystis pneumonia in non-HIV immunocompromised patients with pulmonary infiltrates. Chest. 2009 Mar;135(3):655-61. doi: 10.1378/chest.08-1309.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Christa S. Zerbe, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CLINICAL CENTER BG RM 12C110
10 CENTER DR
BETHESDA MD 20892
(301) 594-5932
zerbech@niaid.nih.gov

Theresa D. Jerussi, P.A.-C
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CRC BG RM 6-5523
10 CENTER DR
BETHESDA MD 20892
(240) 281-1573
jerussitd@cc.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT01919099

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NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Natural History Study of the Complications Associated with Allogeneic Hematopoietic Stem Cell Transplantations

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-I-0177

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 2
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

None

Keywords

Post-Transplant Infection;
Post-Transplant Bacteremia;
Post-Transplant Virus;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Post-Transplant Infections;
Post-Transplant Renal Insufficiency;
Post-Transplant Pulmonary Complications

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

Background:

- The National Institutes of Health (NIH) performs up to 100 allogenic stem cell transplants (allo-HSCT) each year. Many studies already look at different problems that can follow a transplant. But there are many types of transplants, diseases, responses, and treatments. An organized study of this information could help researchers learn more about how often transplant complications occur and what problems they cause. It could also lead to ideas for future research. This study will focus on complications thought to be the most significant.

Objectives:

- To gather information on the complications that may occur after an allo-HSCT.

Eligibility:

- People over 2 years of age currently enrolled in an allo-HSCT study at NIH.

Design:

- Visits for this study will be scheduled along with primary study visits. The number of visits will depend on the primary study schedule.

- At each visit, participants will answer questions and take physical exams.

- The same questions and physical exams will continue for as long as they are in the primary study.

- In between visits, researchers might call participants to discuss their health. They may also discuss the cases with the primary study doctors and other doctors. Primary transplant study doctors will make treatment decisions.

- When participation in the primary transplant study ends, participation in this study will also end.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

Subjects over the age of 2 that are actively enrolled in an allo-HSCT protocol at any NIH institute will be eligible to participate in this study regardless of gender or medical condition. Patients may be consented prior to and up to a week after receiving the stem cells (Day 0 of transplant).

EXCLUSION CRITERIA:

Subjects with any condition that, in the opinion of the investigator, contraindicates participation in the study will be excluded.


--Back to Top--

Citations:

De Pauw B, Walsh TJ, Donnelly JP, Stevens DA, Edwards JE, Calandra T, Pappas PG, Maertens J, Lortholary O, Kauffman CA, Denning DW, Patterson TF, Maschmeyer G, Bille J, Dismukes WE, Herbrecht R, Hope WW, Kibbler CC, Kullberg BJ, Marr KA, Mu(SqrRoot) oz P, Odds FC, Perfect JR, Restrepo A, Ruhnke M, Segal BH, Sobel JD, Sorrell TC, Viscoli C, Wingard JR, Zaoutis T, Bennett JE; European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group; National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Clin Infect Dis. 2008 Jun 15;46(12):1813-21

Seo S, Campbell AP, Xie H, Chien JW, Leisenring WM, Englund JA, Boeckh M. Outcome of respiratory syncytial virus lower respiratory tract disease in hematopoietic cell transplant recipients receiving aerosolized ribavirin: significance of stem cell source and oxygen requirement. Biol Blood Marrow Transplant. 2013 Apr;19(4):589-96. doi: 10.1016/j.bbmt.2012.12.019. Epub 2013 Jan 5.

Azoulay E, Bergeron A, Chevret S, Bele N, Schlemmer B, Menotti J. Polymerase chain reaction for diagnosing pneumocystis pneumonia in non-HIV immunocompromised patients with pulmonary infiltrates. Chest. 2009 Mar;135(3):655-61. doi: 10.1378/chest.08-1309.

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Christa S. Zerbe, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CLINICAL CENTER BG RM 12C110
10 CENTER DR
BETHESDA MD 20892
(301) 594-5932
zerbech@niaid.nih.gov

Theresa D. Jerussi, P.A.-C
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CRC BG RM 6-5523
10 CENTER DR
BETHESDA MD 20892
(240) 281-1573
jerussitd@cc.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT01919099

--Back to Top--