Characterization of Ovarian Cancer Stem Cell

June 6, 2011 updated by: National Taiwan University Hospital

Characterization of Ovarian Cancer Stem Cell: Focus on Identification of Biomarker and Drug Resistance

Specific aims: Identification and characterization of cancer stem cell-like population (cancer stem cells or cancer initiating cells) from primary tumor tissue, primary ascites and peripheral blood of ovarian cancer patients and genetically engineered mouse ovarian cancer cell lines.

Objectives: In the future, individualized therapy must incorporate analysis of the cancer stem cells or cancer initiating cells of ovarian cancer cells when designing therapeutic strategies for ovarian cancer patients.

Aims of this project:

  1. Isolation and identification of cancer stem cell-like population (cancer stem cells or cancer initiating cells) from primary tumor tissue, primary ascites and peripheral blood of ovarian cancer patients
  2. In vivo tumorigenicity assay will be performed to measure tumor formation from these cancer stem cell-like population when equal numbers were injected into the dorsal fat pad of nude mice.
  3. To establish a standard protocol of stem cell-like population maintenance
  4. Screening of potential specific biomarkers involved in these ovarian cancer stem cell-like population.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Ovarian cancer has the highest mortality of all gynecological cancers, with an overall 5-year survival rate of only 30-40%. The incidence of ovarian cancer also increased in recent year in Taiwan, and it became a more and more important issue. The lack of symptoms, difficulties in early diagnosis, insufficient accurate tumor markers, and lack of information about ovarian tumor biology contribute to the poor prognosis in ovarian cancer patients. The prognostic factors for ovarian carcinomas include tumor stage, subtype of histology, grade of differentiation, the residual tumor after debulking surgery, and the response to chemotherapy. Especially the resistance to chemotherapy plays a great role in the prognosis of the patients. However, the current studies present an incomplete picture of the tumor biology of ovarian cancer. It will be quite helpful to clinical management if the investigators can examine the possible underlying mechanism of tumorigenesis and drug resistance.

Malignancy usually origins from the abnormal proliferate cells which accumulate several genetic or epigenetic aberrations. The most important key question is "What kind of cell could be the cancer cell?" Recent studies figure out there is "cancer-initiating cell" in the malignant tumor. Cancer-initiating cells organized self-renewing, anchorage-independent spheres and were reproducibly. Moreover, cancer-initiating cells were also capable of intraperitoneal tumorigenesis (demonstrating activity in their native microenvironment) and could serially propagate tumors in animals. Although the proportion of the cancer-initiating cells in the cancer tissue is very low, the characteristic abilities of cancer-initiating cells fulfill all currently accepted criteria for the existence of a subpopulation of tumor-initiating cells, and their specific detection and targeting could be highly valuable for therapy of tumor heterogeneity, uncontrolled proliferation, local invasion, distant metastasis and even resistance to current management including chemotherapy.

Some tumor initiating cells which have the properties of cancer stem cells have been isolated from leukemia, breast cancer, and brain tumor. Some potential cell markers for cancer initiating cells were identified, including CD34(+)/CD38(+) in leukemia, CD44(+)/CD24(+) in breast cancer, and CD133(+)/nestin(+) in brain tumor. Aberrant cell signal transduction pathway of stem cell is associated with malignant transformation, such as Wnt, Hedgehog, and Notch pathways. Up to our knowledge, the specific antigens expressed on ovarian cancer-initiating cells have not been identified and characterized yet. In the current study, using primary human ovarian tumors, the investigators will isolate and characterized ovarian cancer-initiating cells fully capable of reestablishing their original tumor hierarchy in vivo. The investigators will also elucidate the novel diagnostic and prognostic biomarkers on ovarian cancer-initiating cells by identifying numerous differentially potential surface antigens and/or over-expressed genes. Furthermore, a mouse ovarian cancer study model will be genetically engineered and investigated to monitor the possible therapeutic effects of immunotherapy and chemotherapy to these ovarian cancer-initiating cells. The investigators hope to specify and to stratify the molecular patterns, response to chemotherapy, prognostic biomarkers in patients with ovarian cancer-initiating cells. These results might offer some novel ovarian cancer therapy hypothesis to evaluate its function on tumorigenesis and potential on targeting ovarian cancer-initiating cells.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with ovarian carcinoma who undergo hysterectomy, bilateral oophorectomy and tubal resection, omentectomy, and appendectomy will be enrolled and the clinical data will be obtained from our hospital.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ovarian cancer
Procedure: surgery or debulking surgery
surgery or debulking surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: From disease diagnosis to death (Generally 2~5 years)
From disease diagnosis to death (Generally 2~5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

December 10, 2010

First Submitted That Met QC Criteria

June 6, 2011

First Posted (Estimate)

June 7, 2011

Study Record Updates

Last Update Posted (Estimate)

June 7, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200902010R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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