Characterization of Ovarian Cancer Stem Cell

NCT ID: NCT01367353

Last Updated: 2011-06-07

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ovarian Cancer

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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ovarian cancer

Group Type EXPERIMENTAL

surgery or debulking surgery

Intervention Type PROCEDURE

surgery or debulking surgery

Interventions

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surgery or debulking surgery

surgery or debulking surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan Unviersity Hospital

Principal Investigators

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Wen-Fang Cheng, Professor

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Wen-Fang Cheng, Professor

Role: CONTACT

886-2-23123456 ext. 71964

Facility Contacts

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Wen-Fang Cheng, Professor

Role: primary

886-2-23123456 ext. 71964

Other Identifiers

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200902010R

Identifier Type: -

Identifier Source: org_study_id

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