Structural Imaging and Cognitive Functions in Adult Stem Cell Transplant Recipients Treated With Chemotherapy Alone or in Combination With Radiotherapy
1 other identifier
observational
66
1 country
2
Brief Summary
The purpose of this study is to learn about possible changes in brain anatomy and in thinking abilities, such as memory skills, in patients with cancer who receive treatment with chemotherapy alone or in combination with total body radiation before undergoing stem cell transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2007
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 21, 2008
CompletedFirst Posted
Study publicly available on registry
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 10, 2015
December 1, 2015
8.9 years
January 21, 2008
December 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
assess changes in hippocampal volume & white matter integrity prospectively in adult ca pts who get treatment w/i chemotherapy alone or in combination with total body irradiation (TBI) before undergoing hematopoietic stem cell transplantation.
conclusion of the study
Secondary Outcomes (1)
assess memory and executive functions prospectively in these patients. We will investigate whether there is an association between structural brain changes and cognitive performance.
conclusion of the study
Study Arms (3)
A
TBI and Chemotherapy Conditioning Regimen. Twenty (20) patients will undergo conditioning treatment with TBI and chemotherapy prior to receiving a myeloablative allogeneic or an autologous HSCT.
B
Chemotherapy Alone Conditioning Regimen Twenty (20) patients will undergo conditioning treatment with an all chemotherapy regimen prior to receiving an allogeneic or an autologous HSCT.
C
A cohort of twenty (20) healthy controls, frequency matched on age, gender, and education, will be recruited at WCMC to participate in the study.
Interventions
Patients will undergo a brain MRI study and a brief neuropsychological evaluation, at the time of enrollment for controls and prior to undergoing the conditioning treatment required for the stem cell transplant for patients. A follow-up MRI and cognitive evaluation will be performed approximately 12 months after the transplant for patients.
A brain MRI study and a brief neuropsychological evaluation will be performed at baseline (Time 1). A follow-up MRI and cognitive evaluation will be performed and about 12 months after the baseline for healthy controls
Eligibility Criteria
Subjects will be identified and recruited to participate in the study by Memorial Sloan-Kettering Cancer Center (MSKCC) and Weill Cornell Medical Center (WCMC).
You may qualify if:
- Diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), acute undifferentiated or biphenotypic leukemia, myelodysplastic syndrome (MDS), Hodgkin's lymphoma, (HL) or non-Hodgkin's lymphoma (NHL), and in complete remission at the time of enrollment
- Are scheduled to undergo conditioning treatment with (1) total body radiation (TBI) and chemotherapy or (2) chemotherapy alone prior to receiving a myeloablative allogeneic HSCT
- Between 18 and 70 years of age.
- Are English speaking.
- Have capacity to give consent.
- Have no diagnosis of cancer except basal cell carcinoma
- Between 18 and 70 years of age.
- Are English speaking.
- Have capacity to give consent
You may not qualify if:
- Patients with signs and/or symptoms of central nervous system disease as determined by their physician or by a brain MRI, either at the time of enrollment or during the study period.
- With disease progression at the time of enrollment or during the study period
- With self-reported Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia
- With a history of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness
- With standard contraindications to MRI examinations
- Exposure to chemotherapy or radiation therapy for any medical condition
- With self-reported Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia
- With a history of neurological disorders, neurodegenerative disease, or traumatic brain injury with loss of consciousness
- With standard contraindications to MRI examinations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Weill Cornell Medical Center
New York, New York, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Denise Correa, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2008
First Posted
February 1, 2008
Study Start
January 1, 2007
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
December 10, 2015
Record last verified: 2015-12