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临床试验/NCT01113112
NCT01113112已完成不适用

Biobehavioral-Cytokine Interactions in Ovarian Cancer

Susan Lutgendorf3 个研究点 分布在 1 个国家目标入组 613 人开始时间: 2003年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
613
试验地点
3
主要终点
Biobehavioral Factors

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

Biobehavioral factors

Those with biobehavioral factors that contribute to a permissive local environment for macrophage-tumor interactions that enhance tumor growth in ovarian cancer

结局指标

主要结局

Biobehavioral Factors

时间窗: 1 year post op

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

次要结局

未报告次要终点

研究者

发起方
Susan Lutgendorf
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Susan Lutgendorf

Professor

University of Iowa

研究点 (3)

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