The Expression and Effect of Cyr61 in Urinary Tract Transitional Cell Carcinoma

October 5, 2010 updated by: Far Eastern Memorial Hospital
Cysteine-rich 61 (Cyr61), a member of "CCN" family, regulates cell migration, proliferation, apoptosis, and angiogenesis, cell adhesion, migration, proliferation, survival, differentiation, apoptosis, angiogenesis, and extracellular matrix production. Evidences show strong correlations of aberrant Cyr61 expression in cancers of numerous organs and tissues. However, the expression and effect of Cyr61 in transitional cell carcinoma (TCC), the most common urinary tract cancer in Taiwan, remains undiscovered. Based on previous studies of Cyr61 in other cancer, the investigators hypothesize that Cyr61 may mediate TCC cell proliferation and migration; and associated with disease progression and recurrent. Thus the investigators conduct this project to study the role of Cyr61 in the pathogenesis of TCC. The investigators will retrospectively review medical history of patients with TCC treated at our institutes. Cyr61 immunohistochemical stain of their surgical samples will be performed. The correlation of Cyr61 expression of TCC and patients' clinical courses will be investigated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

  1. Patients: as shown in inclusion criteria
  2. Surgical samples Surgical specimens from included patients with TCC who underwent surgery will be collected. The samples will be examined histologically for the presence of tumor cells. Independent pathologists who are blinded to the records of the patients will perform histological examinations. Tumor grade is determined on the basis of cytological features. There are three grades of TCC, as proposed by Mostofi et al. and adopted by the American Bladder Tumor Registry of the World Health Organization. These are based on degree of anaplasia: Grade 1 tumors show mild cytological atypia and rare mitosis; Grade 2 tumors show moderate cytological atypical and the presence of mitotic figures; and Grade 3 tumors show severe cytological atypia and frequent mitotic figures. Lymph node metastasis, lymphatic invasion, and venous invasion will be evaluated by pathology reports and image study. Clinical staging of TCC is based on the American Joint Committee on Cancer staging (AJCC) TNM system.
  3. Immunohistochemical stain Paraffin-embedded, formalin-fixed surgical specimens were collected for Cyr61 immunohistochemical staining. Heat-induced epitope retrieval will be performed with a pressure cooker and TRIS buffer (pH 9.0) for 2 min. They will be allowed to cool for 15 min, rinsed in distilled water twice and in PBS for 5 min. The sections will then be treated with 0.5% hydrogen peroxidase/PBS for 20 min at room temperature to block the endogenous peroxidase. They will subsequently be blocked with 10% normal goat serum for 30 min at room temperature, and then incubated with polyclonal anti-Cyr61 antibody (Santa Cruz, CA) at 4°C overnight. The specific antibodies will be omitted in sections as negative controls. The sections will be washed three times in PBS/0.2% Triton X-100 for 10 min and incubated with biotin-conjugated secondary antibodies (DAKO, Carpinteria, CA) for 1 hour at room temperature the following day. They will then be incubated with the avidin-biotin-peroxidase reagent (DAKO) for another 1 hour at room temperature. After three washes in PBS/0.2% Triton X-100 for 10 min each, the reactions on sections will be detected with peroxidase substrate containing diaminobenzidine chromagen (DAKO). The slides will be counterstained with hematoxylin. If >50% of the tumor cells are positively stained, the specimen will be grouped as "positive". All other staining results will be regarded as negative.
  4. Statistical analysis For statistical analysis, P values are based on two-sided, parametric Student's t tests. A P value of <0.05 on the basis of at least three independent sets of experiments is considered to be statistically significant. In the clinical sets of project, Chi-squire test and Student's t test will be used to study the association of Cyr61 expression with single clinical factors (age, gender, pathology, and grade). Kaplan-Meier survival curves for patients with positive versus negative Cyr61 expression will be plotted and log-rank test will be used for comparing the equality of the two survival curves. Cox proportional hazard model will also be developed to correlate the clinical characteristics, survival, and the expression of Cyr61.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
    • Taipei
      • Banciao City, Taipei, Taiwan, 220
        • Recruiting
        • Far Eastern Memorial 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We will retrospectively review adult patients (age>18 years) with TCC who received surgery at Far Eastern Memorial Hospital and National Taiwan University Hospital from 2004 to 2008.

Description

Inclusion Criteria:

  • All adult patients (age>18 years) with TCC who received surgery at Far Eastern Memorial Hospital and National Taiwan University Hospital from 2004 to 2008.

Exclusion Criteria:

  • Refuse to participate.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Low Cyr61
Low Cyr61 immunohistochemical stain in patients' TCC tumor
High Cyr61
High Cyr61 immunohistochemical stain in patients' TCC tumor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Patient survival
Time Frame: 5 year
5 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Far Eastern Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chun-Fu Lai, M.D., Far Eastern Memorial 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2010

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 098055-3

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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