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Biobehavioral Influences and the Ovarian Tumor Microenvironment

18 Years
Open (Enrolling)
Ovarian Neoplasms

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Trial Information

Biobehavioral Influences and the Ovarian Tumor Microenvironment

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.

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

- 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

- Inability to accurately answer questions (e.g. a condition such as dementia)

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Biobehavioral Factors

Outcome Description:

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

Outcome Time Frame:

1 year post op

Safety Issue:


Principal Investigator

Premal H Thaker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:

09-0737 / 201104242



Start Date:

July 2009

Completion Date:

July 2014

Related Keywords:

  • Ovarian Neoplasms
  • Ovarian Neoplasms
  • Neoplasms
  • Ovarian Neoplasms



Washington University School of Medicine Saint Louis, Missouri  63110