NCT01113112

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
613

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2003

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2010

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2015

Completed
10.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2026

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

12.3 years

First QC Date

April 27, 2010

Last Update Submit

February 4, 2026

Conditions

Ovarian Neoplasms

Keywords

Ovarian Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Biobehavioral factors

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Gyn/Onc patients at the University of Iowa and Washington University School of Medicine

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, saliva, tissue, ascites

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Susan Lutgendorf, Ph.D.

    University of Iowa

    PRINCIPAL INVESTIGATOR

  • Premal Thaker, MD

    Washington University School of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 27, 2010

First Posted

April 29, 2010

Study Start

August 1, 2003

Primary Completion

November 10, 2015

Study Completion

January 2, 2026

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)