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

NCT01096394 | Completed

• 4 other identifiers: 090075P30CA068485VU-VICC-GYN-0917IRB# 090075
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer

Outcome Measures

Primary Outcomes (1)

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

  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).

  5 year follow up of outcome.

Study Arms (1)

Ovarian cancer

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• National Cancer Institute (NCI): collaborator
• Celgene Corporation: collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Metastatic and primary tumor tissue.

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Dineo Khabele, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: March 31, 2010
• Study Start: November 1, 2009
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 10, 2015

Record last verified: 2015-12

Locations

US (1)