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
  Purpose

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.


Condition Phase
Ovarian Cancer
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Orthotopic Propagation of Primary Human Ovarian Tumors for Preclinical Investigation of Novel Anti-Tumor Agents.

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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).


Biospecimen Retention:   Samples With DNA

Metastatic and primary tumor tissue.


Estimated Enrollment: 20
Study Start Date: November 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ovarian cancer
Patients with presumed Stage III-IV ovarian, primary fallopian tube, or primary peritoneal papillary serous carcinoma.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096394

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
Celgene Corporation
Investigators
Principal Investigator: Dineo Khabele, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Dineo Khabele, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01096394     History of Changes
Other Study ID Numbers: 090075, P30CA068485, VU-VICC-GYN-0917, IRB# 090075
Study First Received: March 30, 2010
Last Updated: December 20, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Vanderbilt University:
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014