Mesothelin as a New Tumor Marker for Ovarian Cancer

NCT00155740 | Unknown

• 1 other identifier: 9100201610
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Cancer

Keywords

ovarian cancer; tumor marker; mesothelin

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Chi-An Chen, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-An Chen, MD

CONTACT

882-2-2312-3456; cachen@ha.mc.ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: OTHER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: January 1, 2002
• Study Completion: December 1, 2006
• Last Updated: November 28, 2005

Record last verified: 2001-10

Locations

TW (1)