Collection of Tissue Samples From Patients With Stage III or Stage IV Ovarian Epithelial Cancer
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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.
| 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. |
- 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 |
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Ovarian cancer
Patients with presumed Stage III-IV ovarian, primary fallopian tube, or primary peritoneal papillary serous carcinoma.
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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 |
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.
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| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
| 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: | January 10, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
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stage III ovarian epithelial cancer stage IV ovarian epithelial cancer |
Additional relevant MeSH terms:
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Ovarian Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 21, 2013