Clinical trial NCT01591772: Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer
Official title: Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cancer
Keywords: FALLOPIAN TUBE
OVARY
PERITONEUM
Quality of Life
structural MRI
functional MRI
neuropsychological assessment
12-075
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
name: Rutgers University
First posted: 2012-05-04
Enrollment: 36
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be identified and recruited by physicians in the Gynecologic Medical Oncology Clinic at MSKCC.

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.


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.

Primary outcomes:
measure: alterations in regional brain volume
timeFrame: 1 year
measure: dorsolateral prefrontal cortex
timeFrame: 1 year
Secondary outcomes:
measure: neuropsychological functions
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Denise Correa, PhD
role: PRINCIPAL_INVESTIGATOR
References: