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Biobehavioral-Cytokine Interactions in Ovarian Cancer (VEGF)

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ClinicalTrials.gov Identifier: NCT01113112
Recruitment Status : Active, not recruiting
First Posted : April 29, 2010
Last Update Posted : February 28, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Washington University School of Medicine
Information provided by (Responsible Party):
Susan Lutgendorf, University of Iowa

April 27, 2010
April 29, 2010
February 28, 2017
August 2003
November 10, 2015   (Final data collection date for primary outcome measure)
Biobehavioral Factors [ Time Frame: 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
Same as current
Complete list of historical versions of study NCT01113112 on ClinicalTrials.gov Archive Site
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Biobehavioral-Cytokine Interactions in Ovarian Cancer
Biobehavioral-Cytokine Interactions in Ovarian Cancer
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
serum, saliva, tissue, ascites
Non-Probability Sample
Gyn/Onc patients at the University of Iowa and Washington University School of Medicine
Ovarian Neoplasms
Not Provided
Biobehavioral factors
Those with biobehavioral factors that contribute to a permissive local environment for macrophage-tumor interactions that enhance tumor growth in ovarian cancer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
613
December 31, 2025
November 10, 2015   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01113112
200308061
R01CA104825 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Susan Lutgendorf, University of Iowa
University of Iowa
  • National Cancer Institute (NCI)
  • Washington University School of Medicine
Principal Investigator: Susan Lutgendorf, Ph.D. University of Iowa
Study Chair: Premal Thaker, MD Washington University School of Medicine
University of Iowa
February 2017