Characterization of Ovarian Cancer Stem Cell

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01367353
Recruitment Status : Unknown
Verified May 2011 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : June 7, 2011
Last Update Posted : June 7, 2011
Information provided by:
National Taiwan University Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Procedure: surgery or debulking surgery Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Characterization of Ovarian Cancer Stem Cell: Focus on Identification of Biomarker and Drug Resistance
Study Start Date : January 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ovarian cancer Procedure: surgery or debulking surgery
surgery or debulking surgery

Primary Outcome Measures :
  1. overall survival [ Time Frame: From disease diagnosis to death (Generally 2~5 years) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01367353

Contact: Wen-Fang Cheng, Professor 886-2-23123456 ext 71964

National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Wen-Fang Cheng, Professor    886-2-23123456 ext 71964   
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Wen-Fang Cheng, Professor National Taiwan University Hospital

Responsible Party: Wen-Fang Cheng/Professor, National Taiwan Unviersity Hospital Identifier: NCT01367353     History of Changes
Other Study ID Numbers: 200902010R
First Posted: June 7, 2011    Key Record Dates
Last Update Posted: June 7, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders