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


Phase 1
18 Years
80 Years
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

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


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.

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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Establishment of a "live" library of primary ovarian epithelial tumors

Outcome Description:

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).

Outcome Time Frame:

5 year follow up of outcome.

Safety Issue:

No

Principal Investigator

Dineo Khabele, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

090075

NCT ID:

NCT01096394

Start Date:

November 2009

Completion Date:

March 2015

Related Keywords:

  • Ovarian Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838