Clinical trial NCT00606216: Structural Imaging and Cognitive Functions in Adult Stem Cell Transplant Recipients Treated With Chemotherapy Alone or in Combination With Radiotherapy
Official title: Structural Imaging and Cognitive Functions in Adult Stem Cell Transplant Recipients Treated With Chemotherapy Alone or in Combination With Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Acute Undifferentiated Leukemia
Biphenotypic Leukemia
Myelodysplastic Syndrome
Non-Hodgkin's Lymphoma
Keywords: MRI
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2008-02-01
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be identified and recruited to participate in the study by Memorial Sloan-Kettering Cancer Center (MSKCC) and Weill Cornell Medical Center (WCMC).

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Healthy Control Inclusion Criteria:

* Have no diagnosis of cancer except basal cell carcinoma
* Between 18 and 70 years of age.
* Are English speaking.
* Have capacity to give consent

Exclusion Criteria:

* 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

Healthy Control Exclusion Criteria:

* 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

Primary outcomes:
measure: 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.
timeFrame: conclusion of the study
Secondary outcomes:
measure: assess memory and executive functions prospectively in these patients. We will investigate whether there is an association between structural brain changes and cognitive performance.
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Denise Correa, PhD
role: PRINCIPAL_INVESTIGATOR
References: