Viewing Study NCT00155740



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Last Modification Date: 2024-10-26 @ 9:15 AM
Study NCT ID: NCT00155740
Status: UNKNOWN
Last Update Posted: 2005-11-28
First Post: 2005-09-09

Brief Title: Mesothelin as a New Tumor Marker for Ovarian Cancer
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: None
Status: UNKNOWN
Status Verified Date: 2001-10
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 andor 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 andor 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
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 andor 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 andor 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 carcinomas25 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None