Brief Title
Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer
Official Title
Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer
Brief Summary
The purpose of this study is to learn about possible changes in brain anatomy and function,
and in thinking abilities, such as memory skills, in patients with ovarian cancer who receive
treatment with chemotherapy. Cancer patients treated with chemotherapy may experience changes
in thinking abilities, and these may interfere with quality of life. Most of the research to
date has involved patients with breast cancer, and there are no studies in women with ovarian
cancer looking at at treatment-related changes in brain anatomy and function.
Study Type
Observational
Primary Outcome
alterations in regional brain volume
Secondary Outcome
neuropsychological functions
Condition
Fallopian Tube Cancer
Intervention
Neuroimaging & Neuropsychological Evaluation
Study Arms / Comparison Groups
diagnosed with ovarian that recieved chemo
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
36
Start Date
April 24, 2012
Completion Date
May 25, 2022
Primary Completion Date
May 25, 2022
Eligibility Criteria
Inclusion Criteria:
- diagnosed with stage I-IV ovarian, peritoneal or fallopian tube cancer
- completed first-line taxane and platinum-based chemotherapy 1-4 months prior to being
enrolled in the study (can be on bevacizumab maintenance)
- in remission of their disease at the time of enrollment between 21 and 70 years of age
- fluent in English
- in the judgment of the consenting professional, have capacity to give consent
Healthy Control Inclusion Criteria:
- no diagnosis of cancer except basal cell carcinoma
- between 21 and 70 years of age
- fluent in English
- has a mini-mental state exam (MMSE) score of 26 or higher
- in the judgment of the consenting professional, have capacity to give consent
Exclusion Criteria:
- active or recurrent disease, or diagnosis of another cancer (except basal cell
carcinoma) as per medical records at the time of enrollment
- exposure to chemotherapy or radiation therapy for any medical condition unrelated to
ovarian cancer
- on hormonal therapy at the time of enrollment
- neurological disorder or moderate to severe head trauma (loss of consciousness > 60
min)
- neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, multiple
sclerosis, etc.
- self-reported Axis I psychiatric disorder (DSM-IV), major affective disorder
(untreated), bipolar disorder, schizophrenia
- unable to complete cognitive tests
- with standard contraindications to MRI examinations
Healthy Control Exclusion Criteria:
- exposure to chemotherapy or radiation therapy for any medical condition
- on hormone replacement therapy at the time of enrollment
- neurological disorder or moderate to severe head trauma (loss of consciousness > 60
min)
- neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, multiple
sclerosis, etc.
Gender
Female
Ages
21 Years - 70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Denise Correa, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01591772
Organization ID
12-075
Responsible Party
Sponsor
Study Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Weill Medical College of Cornell University
Study Sponsor
Denise Correa, PhD, Principal Investigator, Memorial Sloan Kettering Cancer Center
Verification Date
May 2022