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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Celgene Corporation
Information provided by (Responsible Party):
Dineo Khabele, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01096394
First received: March 30, 2010
Last updated: December 20, 2013
Last verified: December 2013

March 30, 2010
December 20, 2013
November 2009
March 2015   (final data collection date for primary outcome measure)
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).
Establishment of a "live" library of primary ovarian epithelial tumors [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01096394 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Metastatic and primary tumor tissue.

Non-Probability Sample

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.

Ovarian Cancer
Not Provided
Ovarian cancer
Patients with presumed Stage III-IV ovarian, primary fallopian tube, or primary peritoneal papillary serous carcinoma.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Female
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01096394
090075, P30CA068485, VU-VICC-GYN-0917, IRB# 090075
No
Dineo Khabele, Vanderbilt University
Vanderbilt University
  • National Cancer Institute (NCI)
  • Celgene Corporation
Principal Investigator: Dineo Khabele, MD Vanderbilt-Ingram Cancer Center
Vanderbilt University
December 2013

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