The Prognostic and Predictive Value of the CA-125 Marker in Lung Cancer Monitoring

May 5, 2015 updated by: E-DA Hospital

Determination of the Prognostic and Predictive Value of the Cancer Antigen-125 (CA-125) Marker in Lung Cancer Monitoring

The tumor associated CA-125antigen for diagnosis and follow-up of ovarian cancer was well defined. Increased serum CA125 level may have many diagnoses other than ovarian cancer, including breast, colorectal and lung cancer. 80% lung cancer patients were diagnosed at advanced stage. Malignant pleural effusion secondary to lung cancer represented the condition of cancer cell involved pleura.

The CA-125 level may reflect the extent of tumor involved in pleura (tumor burden), it could be correlated with the prognosis. This study was performed to examine the properties of CA-125 by measuring pleural and blood CA-125 levels in lung cancer with or without malignant pleural effusion; meanwhile to examine whether the rate of decline in CA 125 during primary therapy as a surrogate indicator for survival.

Study Overview

Status

Unknown

Conditions

Lung Cancer

Intervention / Treatment

Other: serum and pleural effusion CA-125 level

Study Type

Observational

Enrollment (Anticipated)

200

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
- - Kaohsiung, Taiwan
    - Recruiting
    - E-Da Hospital
    - Contact:
      
      Jiun-Ting Wu, MD
      
      Phone Number: 5026 886-7-615-0011
      
      Email: jt600729@ms13.hinet.net
    - Principal Investigator:
      
      Jiun-Ting Wu, MD

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with histologically proved lung cancer

Description

Inclusion Criteria:

Histologically proved lung cancer

Exclusion Criteria:

History of other cancers within the past 5 years
Pregnancy or breast milk feeding
TB pleuritis and peritonitis

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

Observational Models: Case-Control
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The diagnostic Value of the cancer antigen-125 in lung cancer Time Frame: 12months	Comparison of CA-125 level in serum between lung cancer patients with or without malignant pleural effusion The correlation between serum and pleural effusion CA-125 level	12months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prognostic value of the cancer antigen-125 in lung cancer Time Frame: 24 months	Association of serum/ pleural effusion CA-125 level with Disease-Free Survival and Overall Survival The correlation of CA-125 response at the 3rd , the 6th month between tumor lesion change Analysis of survival in relation to CA-125 response	24 months

Collaborators and Investigators

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

Sponsor

E-DA 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

February 1, 2015

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

April 18, 2015

First Submitted That Met QC Criteria

May 5, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Estimate)