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

• Conditions: Lung Cancer

• Registration Number: NCT02437760
• Lead Sponsor: E-DA Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-04-18
• Status Verified: 2015-05
• Study First Submitted QC: 2015-05-05
• Last Update Submitted: 2015-05-05
• Study First Posted: 2015-05-08
• Last Update Posted: 2015-05-08
• Primary Completion: 2017-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The diagnostic Value of the cancer antigen-125 in lung cancer	12months	1. Comparison of CA-125 level in serum between lung cancer patients with or without malignant pleural effusion; 2. The correlation between serum and pleural effusion CA-125 level

Secondary Outcome Measures

Name	Time	Method
The prognostic value of the cancer antigen-125 in lung cancer	24 months	1. Association of serum/ pleural effusion CA-125 level with Disease-Free Survival and Overall Survival; 2. The correlation of CA-125 response at the 3rd , the 6th month between tumor lesion change; 3. Analysis of survival in relation to CA-125 response

Trial Locations

Locations (1)

E-DA hospital; 🇨🇳 Kaohsiung, Taiwan