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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-06749 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 19424 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| R01HL150069 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This study evaluates how well the heart, lungs, and muscles are working individually, and how these systems are working together in transplant survivors. Information collected in this study may help doctors to understand why hematopoietic stem cell transplant survivors are at higher risk for developing cardiovascular disease.
PRIMARY OBJECTIVES:
I. Evaluate cardiovascular reserve capacity, as measured by peak oxygen consumption (VO2peak), in hematopoietic cell transplantation (HCT) survivors.
II. Define the determinants of VO2peak impairment in HCT survivors.
OUTLINE:
Patients undergo echocardiogram to assess cardiac function and mechanics, cardiopulmonary exercise test, pulmonary function test, musculoskeletal ultrasound, bioelectrical impedance analysis to measure total lean body mass and percent body fat), physical function tests, and collection of blood samples within 45 days from the start of conditioning therapy, and at 6 months, 1 year, and 2 years post-transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (physical assessment) | Patients undergo echocardiogram to assess cardiac function and mechanics, cardiopulmonary exercise test, pulmonary function test, musculoskeletal ultrasound, bioelectrical impedance analysis to measure total lean body mass and percent body fat), physical function tests, and collection of blood samples within 45 days from the start of conditioning therapy, and at 6 months, 1 year, and 2 years post-transplant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioelectric Impedance Analysis | Procedure | Undergo bioelectric impedance analysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular reserve capacity, as measured by VO2peak, in HCT survivors | We will measure initial VO2peak in patients prior to HCT and its post-HCT trajectory over time; compare VO2peak in HCT survivors at baseline (pre-HCT), 6m, 1Y, and 2Y post-HCT to established age- and sex-normative data; and define the association between VO2peak and self-reported health-related quality of life (HRQOL) at baseline/over time. | Up to 24 months post-hematopoietic cell transplantation (HCT) |
| Determinants of VO2peak impairment in HCT survivors | We will use Generalized Estimating Equation(GEE) and generalized linear models to examine the correlation between VO2peak and measures of:
| Up to 24 months post-hematopoietic cell transplantation (HCT) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with acute leukemia (myeloid, lymphoid), lymphoma (non-Hodgkin, Hodgkin), multiple myeloma or myelodysplastic syndromes
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| Name | Affiliation | Role |
|---|---|---|
| Saro H Armenian | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 11, 2024 |
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Blood
| Biospecimen Collection | Procedure | Undergo collection of blood samples |
|
| Cardiopulmonary Exercise Testing | Procedure | Undergo cardiopulmonary exercise test |
|
|
| Echocardiography | Procedure | Undergo echocardiogram |
|
| Physical Performance Testing | Procedure | Undergo physical function tests |
|
|
| Pulmonary Function Test | Procedure | Undergo pulmonary function test |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Ultrasound | Procedure | Undergo musculoskeletal ultrasound |
|
| Jul 29, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2023 | Jul 29, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D019337 | Hematologic Neoplasms |
| D006689 | Hodgkin Disease |
| D009190 | Myelodysplastic Syndromes |
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D009371 | Neoplasms by Site |
| D008223 | Lymphoma |
| D001855 | Bone Marrow Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| C039811 | Clostridium perfringens epsilon-toxin |
| D012143 | Respiratory Physiological Phenomena |
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
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