Biobehavioral-Cytokine Interactions in Ovarian Cancer

NCT01113112CompletedOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Susan Lutgendorf

Enrollment

613

Start Date

2003-08-01

Completion Date

2015-11-10

Study Type

OBSERVATIONAL

Official Title

Biobehavioral-Cytokine Interactions in Ovarian Cancer

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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)

Outcome Measures

Primary Outcomes

Biobehavioral Factors

Pathways by which biobehavioral factors contribute to a permissive local environment for macrophage-tumor interactions that enhance tumor growth in ovarian cancer

Time frame: 1 year post op

Locations

University of Iowa Hospitals and Clinics, Iowa City, United States

Washington University School of Medicine, St Louis, United States

Biobehavioral-Cytokine Interactions in Ovarian Cancer