Biobehavioral-Cytokine Interactions in Ovarian Cancer

Ovarian Neoplasms Clinical Trial

— VEGF  

Official title:

Biobehavioral-Cytokine Interactions in Ovarian Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01113112
• Other study ID #: 200308061
• Secondary ID: R01CA104825
• Status: Active, not recruiting
• Start date: August 2003
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 613
• Est. completion date: December 31, 2025
• Est. primary completion date: November 10, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ovarian Neoplasms

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Susan Lutgendorf	National Cancer Institute (NCI), University of Iowa, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biobehavioral Factors	Pathways by which biobehavioral factors contribute to a permissive local environment for macrophage-tumor interactions that enhance tumor growth in ovarian cancer	1 year post op