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

This study is currently recruiting participants.

Verified January 2013 by Vanderbilt University

Sponsor:

Collaborators:

National Cancer Institute (NCI)

Celgene Corporation

Information provided by (Responsible Party):

Dineo Khabele, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT01096394

First received: March 30, 2010

Last updated: January 10, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 30, 2010

Last Updated Date

January 10, 2013

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Establishment of a "live" library of primary ovarian epithelial tumors [ Time Frame: 5 year follow up of outcome. ] [ Designated as safety issue: No ]

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).

Original Primary Outcome Measures ^ICMJE

Establishment of a "live" library of primary ovarian epithelial tumors [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01096394 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Metastatic and primary tumor tissue.

Sampling Method

Non-Probability Sample

Study Population

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.

Condition ^ICMJE

Ovarian Cancer

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Ovarian cancer

Patients with presumed Stage III-IV ovarian, primary fallopian tube, or primary peritoneal papillary serous carcinoma.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2015

Estimated Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01096394

Other Study ID Numbers ^ICMJE

090075, P30CA068485, VU-VICC-GYN-0917, IRB# 090075

Has Data Monitoring Committee

Responsible Party

Dineo Khabele, Vanderbilt University

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

National Cancer Institute (NCI)
Celgene Corporation

Investigators ^ICMJE

Principal Investigator:

Dineo Khabele, MD

Vanderbilt-Ingram Cancer Center

Information Provided By

Vanderbilt University

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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