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CompletedNCT01096394Updated Dec 10, 2015

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

An observational study in Ovarian Cancer, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-12-10.

Sponsored by Vanderbilt University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 80 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Ovarian Cancer

Keywords

  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
03

In context

Carcinoma, Ovarian Epithelial

1,617 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 246 are open to participants now.

This study's enrollment of 20 is below the median of 150 across 304 observational studies indexed under Carcinoma, Ovarian Epithelial.

Browse Carcinoma, Ovarian Epithelial studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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.

Inclusion criteria

  • 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 criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Ovarian cancer

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

06

What researchers measure

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).

    Time frame: 5 year follow up of outcome.

07

Study locations

1 site
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37232-6838, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01096394
Lead sponsor
Vanderbilt University
Collaborators
National Cancer Institute (NCI), Celgene Corporation
Responsible party
Dineo Khabele (Assistant Professor, Vanderbilt University) — Principal investigator
First posted
Mar 31, 2010
Start date
Nov 2009
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Dec 10, 2015

Study contacts

Dineo Khabele, MD
principal investigator · Vanderbilt-Ingram Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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