Biobehavioral Influences and the Ovarian Tumor Microenvironment
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Purpose
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.
| Condition |
|---|
|
Ovarian Neoplasms |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Biobehavioral Influences and the Ovarian Tumor Microenvironment |
- Biobehavioral Factors [ Time Frame: 1 year post op ] [ Designated as safety issue: No ]Pathways by which biobehavioral factors contribute to a permissive local environment for macrophage-tumor interactions that enhance tumor growth in ovarian cancer
Biospecimen Retention: Samples With DNA
serum, saliva, tissue, ascites
| Estimated Enrollment: | 195 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Biobehavioral factors
Those with biobehavioral factors that contribute to a permissive local environment for macrophage-tumor interactions that enhance 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Gyn/Onc patients at Washington University School of Medicine
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)
Contacts and Locations| Contact: Kirthika Vijayakumar | 314-362-6196 | vijayakumark@wudosis.wustl.edu |
| Contact: Premal H Thaker, MD | 314-747-3604 | thakerp@wudosis.wustl.edu |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Kirthika Vijayakumar 314-362-6196 vijayakumark@wudosis.wustl.edu | |
| Principal Investigator: Premal Thaker, MD | |
| Principal Investigator: | Premal H Thaker, MD | Washington University School of Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01113112 History of Changes |
| Other Study ID Numbers: | 09-0737 / 201104242 |
| Study First Received: | April 27, 2010 |
| Last Updated: | December 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
Ovarian Neoplasms |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on May 23, 2013