Clinical trial NCT01113112: Biobehavioral-Cytokine Interactions in Ovarian Cancer
Official title: Biobehavioral-Cytokine Interactions in Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ovarian Neoplasms
Keywords: Ovarian Neoplasms
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: University of Iowa
name: National Cancer Institute (NCI)
name: Washington University School of Medicine
First posted: 2010-04-29
Enrollment: 613
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gyn/Onc patients at the University of Iowa and Washington University School of Medicine

Brief summary: The purpose of this study is to understand relationships between behavioral factors, hormones, and chemicals produced by the body that may help tumor growth in ovarian cancer.

Detailed description: Ovarian cancer is the second most common gynecologic cancer. Because of low rates of survival for the majority of ovarian cancer patients, identification of factors contributing to tumor progression is of paramount importance. Epidemiologic studies have suggested an association between biobehavioral factors such as life stress, depression, low social support and cancer progression. Direct links have been demonstrated between biobehavioral factors and cytokines supporting angiogenesis, the formation of new blood vessels that enhance tumor growth and progression. However, little is known regarding tumor associated macrophages (TAM) and interactions between TAM tumor cells in a way that favors tumor growth, but there is preliminary data indicating that ovarian cancer patients with higher levels of depressive symptoms and life stress have greater TAM production of matrix metalloproteinase-9, a key molecule promoting angiogenesis and tumor invasion. We also have preliminary data that ovarian cancer patients with high levels of depressive symptoms accompanied by low social support have greater tumor expression of a number of genes related to inflammation and tumor progression.

Eligibility criteria: Inclusion Criteria:

* Patients with a histologic diagnosis of epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer; FIGO stage I to IV defined surgically at the completion of the initial abdominal surgery and with appropriate tissue available for histologic evaluation.
* Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell carcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified. However, the histologic features must be compatible with primary Mullerian epithelial adenocarcinoma.
* GOG performance status 0-3

Exclusion Criteria:

* Patients with a diagnosis of borderline epithelial ovarian tumor (formerly: tumors of low malignant potential" or recurrent invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer treated with chemotherapy or radiotherapy previously are excluded.
* Patients who received neoadjuvant chemotherapy for ovarian, primary peritoneal, or fallopian tube carcinoma are excluded.
* Non-epithelial ovarian cancers or metastases to the ovaries from organs are excluded.
* Previous cancer diagnosis except for basal cell carcinoma of the skin or history of lymphoma.
* Pregnancy or age \<18 years old
* Use of systemic glucocorticoids such as prednisone or decadron in the last 30 days
* Comorbid conditions: Addison's disease, autoimmune hepatitis, hepatitis B, hepatitis C, AIDS or HIV, lupus erythematosus, mixed connective tissue disease, rheumatoid arthritis.
* Inability to accurately answer questions (e.g. a condition such as dementia)

Primary outcomes:
measure: Biobehavioral Factors
timeFrame: 1 year post op
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: University of Iowa
name: Susan Lutgendorf, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Premal Thaker, MD
role: STUDY_CHAIR
References: