ClinicalTrials.gov
ClinicalTrials.gov Menu

Biobehavioral-Cytokine Interactions in Ovarian Cancer (VEGF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01113112
Recruitment Status : Active, not recruiting
First Posted : April 29, 2010
Last Update Posted : August 29, 2018
Sponsor:
Collaborators:
University of Iowa
National Cancer Institute (NCI)
Washington University School of Medicine
Information provided by (Responsible Party):
Susan Lutgendorf, University of Iowa

Brief Summary:
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 or disease
Ovarian Neoplasms

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.

Study Type : Observational
Actual Enrollment : 613 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biobehavioral-Cytokine Interactions in Ovarian Cancer
Actual Study Start Date : August 2003
Actual Primary Completion Date : November 10, 2015
Estimated Study Completion Date : December 31, 2025


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



Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
serum, saliva, tissue, ascites


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Gyn/Onc patients at the University of Iowa and 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113112


Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Susan Lutgendorf
University of Iowa
National Cancer Institute (NCI)
Washington University School of Medicine
Investigators
Principal Investigator: Susan Lutgendorf, Ph.D. University of Iowa
Study Chair: Premal Thaker, MD Washington University School of Medicine

Responsible Party: Susan Lutgendorf, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01113112     History of Changes
Other Study ID Numbers: 200308061
R01CA104825 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2010    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Susan Lutgendorf, University of Iowa:
Ovarian Neoplasms

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders