Collection of Tissue Samples From Patients With Stage III or Stage IV Ovarian Epithelial Cancer

Orthotopic Propagation of Primary Human Ovarian Tumors for Preclinical Investigation of Novel Anti-Tumor Agents.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01096394

Enrollment

Registered

2010-03-31

Start date

2009-11-30

Completion date

2015-10-31

Last updated

2015-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer

Brief summary

RATIONALE: Collecting and storing samples of tumor tissue and ascites fluid from patients to test in the laboratory may help the study of cancer. PURPOSE: This pre-clinical research study is collecting tissue samples and ascites fluid from patients with stage III or stage IV ovarian/primary peritoneal/fallopian tube epithelial cancer.

Detailed description

OBJECTIVES: * To generate a translational ovarian cancer model using tumor tissue and cells from patients with stage III-IV ovarian/primary peritoneal/fallopian tube epithelial cancer for drug response and development. OUTLINE: Tissue and fluid samples are collected at the time of surgery or paracentesis and used in laboratory experiments and in animal models. Health data is collected from patient medical records before, during, and after surgery. After surgery, patients are followed up for 5 years.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

INCLUSION: • Females age 18-80 with a diagnosis of Stage III-IV ovarian cancer, primary fallopian tube, or primary peritoneal papillary serous carcinoma and scheduled treatment for epithelial ovarian malignancies. EXCLUSION: * Patients with less than Stage III epithelial ovarian cancer, primary fallopian tube, or primary peritoneal papillary serous carcinoma * Patients who have received prior chemotherapy * Patients who have nonepithelial ovarian cancer, primary fallopian tube, or primary peritoneal carcinoma * Patients who have malignancy other than ovarian cancer, primary fallopian tube, or primary peritoneal carcinoma

Design outcomes

Primary

Measure	Time frame	Description
Establishment of a live library of primary ovarian epithelial tumors	5 year follow up of outcome.	Our approach is to establish a live library of primary tumors from patients diagnosed with ovarian cancer by transplanting this tissue into a host mouse model. This preclinical model system will allow us to test the response to standard and novel therapeutics and will provide a perpetual tumor archive for future experiments that will probe critical molecular pathways involved in the pathogenesis of ovarian cancer and similar cancer types (primary peritoneal and fallopian tube).

Countries

United States

Outcome results