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

NCT ID: NCT01096394

Last Updated: 2015-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

stage III ovarian epithelial cancer stage IV ovarian epithelial cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ovarian cancer

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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:

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Celgene Corporation

INDUSTRY

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dineo Khabele

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dineo Khabele, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P30CA068485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VU-VICC-GYN-0917

Identifier Type: OTHER

Identifier Source: secondary_id

IRB# 090075

Identifier Type: OTHER

Identifier Source: secondary_id

090075

Identifier Type: -

Identifier Source: org_study_id