Biobehavioral Influences and the Ovarian Tumor Microenvironment

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Washington University School of Medicine
Sponsor:
Collaborator:
University of Iowa
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01113112
First received: April 27, 2010
Last updated: December 20, 2012
Last verified: December 2012
  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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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
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
Study Population

Gyn/Onc patients at Washington University School of Medicine

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113112

Contacts
Contact: Kirthika Vijayakumar 314-362-6196 vijayakumark@wudosis.wustl.edu
Contact: Premal H Thaker, MD 314-747-3604 thakerp@wudosis.wustl.edu

Locations
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         
Sponsors and Collaborators
Washington University School of Medicine
University of Iowa
Investigators
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:
Neoplasms
Ovarian 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 September 30, 2014