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Ovarian CancerNCT00155740

Mesothelin as a New Tumor Marker for Ovarian Cancer

An observational study of Ovarian Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 90 years, women onlyHealthy volunteers can take part
Conditions the study is for
Ovarian Cancer
How many people
250 participants
Where
1 siteTaiwan
Study dates
Jan 2002to Dec 2006
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 90 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei

    Chi-An Chen, MD, 886-2-2312-3456 ext. 5157, cachen@ha.mc.ntu.edu.tw

    Recruiting

Other trials in Taiwan

About this study

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.

Read the 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.

Conditions
Ovarian Cancer
Keywords
ovarian cancer, tumor marker, mesothelin
Medical subject headings
Ovarian Neoplasms

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startJan 2002
  3. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Defined population
Time perspective
Other
Enrolment
250 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00155740
Sponsor's protocol ID
9100201610
Status last verified
Oct 2001
First submitted
9 Sep 2005
Last updated
28 Nov 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chi-An Chen, MD (882-2-2312-3456 ext. 5157, cachen@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2005.

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