Mesothelin as a New Tumor Marker for Ovarian Cancer

November 25, 2005 updated by: National Taiwan University Hospital

Ovarian cancer became a more and more important disease in recent years due to its first mortality rate of gynecologic malignancies. The incidence of ovarian cancer also increased in recent year in Taiwan. 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 parameters for ovarian carcinomas are tumor stage, histologic subtype, degree of malignancy, and residual tumor after surgical treatment. However, these factors present an incomplete picture of the tumor biology of ovarian cancer and are frequently interrelated. Thus, the identification of new biologic factors predictive of individual disease course and prognosis would be extremely useful.

Detection of tumor markers that are released into the circulation can aid in the diagnosis and/or monitoring of therapeutic responses of patients with various tumors, including carcinomas of ovary. CA125 is the most commonly used serum marker for patients with ovarian carcinoma. Although it has proven clinically valuable in monitoring the response of patients to therapy, some ovarian carcinomas do not express CA125, and CA125 often is increased in patients with inflammatory disease. Thus, there is a need for improvement, either in the form of a more specific and/or sensitive assay or an assay that uses a different marker and can be used to complement CA125 toward the goal to improve patient survival by improving diagnosis.

Mesothelin is a 40-kDa glycosylphosphatidylinositol-linked glycoprotein. In normal tissues, the expression of mesothelin has subsequently been shown to be largely restricted to mesothelial cells, although immunoreactivity has also been reported in epithelial cells of the trachea, tonsil, fallopian tube, and kidney. Mesothelin has been shown to be over-expressed in pancreatic carcinomas, gastric carcinoma and ovarian carcinoma, and it seems that mesothelin may be utilized as a new tumor marker for ovarian carcinoma. We will evaluate that if mesothelin can be a new potential tumor marker for ovarian cancer in this proposal.

Study Overview

Status

Unknown

Conditions

Detailed Description

Incidence of Ovarian Cancer Ovarian cancer is the first mortality rate of gynecologic malignancies (1-3) and became a more and more important disease in recent years (4-6). The incidence of ovarian cancer also increased in recent year in Taiwan (7). Ovarian cancer has the highest mortality of all gynecological cancers, with an overall 5-year survival rate of only 20-30% (1). 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 (8). The prognostic parameters for ovarian carcinomas are tumor stage, histologic subtype, degree of malignancy, and residual tumor after surgical treatment (9-12). However, these factors present an incomplete picture of the tumor biology of ovarian cancer and are frequently interrelated (13). Thus, the identification of new biologic factors predictive of individual disease course and prognosis would be extremely useful. From the above-mentioned data, ovarian cancer indeed is a disease that should be respected, however, there were only few of research work focusing on it in Taiwan.

Tumor marker for ovarian cancer Detection of tumor markers that are released into the circulation can aid in the diagnosis and/or monitoring of therapeutic responses of patients with various tumors, including carcinomas of ovary (14-17), prostate (18), the gastrointestinal tract (19, 20), or breast (21). CA125 is the most commonly used serum marker for patients with ovarian carcinoma (14). Although it has proven clinically valuable in monitoring the response of patients to therapy, some ovarian carcinomas do not express CA125, and CA125 often is increased in patients with inflammatory disease. Thus, there is a need for improvement, either in the form of a more specific and/or sensitive assay or an assay that uses a different marker and can be used to complement CA125 toward the goal to improve patient survival by improving diagnosis.

New potential molecule as tumor marker for ovarian cancer Mesothelin is a 40-kDa glycosylphosphatidylinositol-linked glycoprotein. It is synthesized as a precursor of molecular mass 69 kDa, which then is proteolytically processed into an N terminal secreted form of molecular mass 30 kDa and a membrane-bound form of 40 kDa (22, 23). The 30-kDa secreted form has been termed megakaryocyte potentiating factor (23). In normal tissues, the expression of mesothelin has subsequently been shown to be largely restricted to mesothelial cells, although immunoreactivity has also been reported in epithelial cells of the trachea, tonsil, fallopian tube, and kidney (24). Mesothelin has been shown to be expressed in pancreatic carcinomas(25), gastric carcinoma (26) and ovarian carcinoma (27), and it seems that mesothelin may be utilized as a tumor marker for ovarian carcinoma.

We will evaluate the amount of mesothelin in pre- and post-treatment serum samples of patients with epithelial ovarian cancer. We will also correlate the clinicopathologic items and the prognosis of ovarian cancer patients and evaluate whether mesothelin can be a new rumor marker for ovarian cancer patients.

Study Type

Observational

Enrollment

250

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
        • Contact:

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 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

- Patients with ovarian carcinoma who undergo hysterectomy, bilateral salpingo-oophorectomy, omentectomy, and appendectomy will be enrolled and the clinical data will be obtained from our hospital. All of the patients received four to six courses of adjuvant platinum-containing chemotherapy.Histologic grading was according to International Union against Cancer criteria (28). The stage of disease was classified according to the International Federation of Gynecology and Obstetrics (FIGO, 1987). Pelvic and paraaortic lymph node samplings will be performed, if the disease will be confined to within the ovary or will be without a ruptured capsule. The histopathologic data, including histologic type and histologic grade, will be evaluated by a certified pathologist. The maximal diameter of the residual tumor after surgery will be also recorded. All patients will be followed up at 3-month intervals.

Patients with ovarian endometrioma, other benign ovarian tumors receiving surgical intervention, or healthy patients without surgical intervention will be presented as normal controls.

Exclusion Criteria:

-

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

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Chi-An Chen, MD, 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, 2002

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

November 28, 2005

Last Update Submitted That Met QC Criteria

November 25, 2005

Last Verified

October 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9100201610

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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