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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02437760
• Other study ID #: EMRP49103N
• Status: Recruiting
• Phase: N/A
• First received: April 18, 2015
• Last updated: May 5, 2015
• Start date: February 2015
• Est. completion date: February 2018

Study information

• Verified date: May 2015
• Source: E-DA Hospital
• Contact: Jiun-Ting Wu, MD
• Phone: 886-07-6150011
• Email: ed103621[@]edah.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• serum and pleural effusion CA-125 level
serum and pleural effusion(if exist) CA-125 are collected: at time of diagnosis every 3 month during treatment stop at the progression or after 12 months

Locations

Country	Name	City	State
Taiwan	E-DA hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
E-DA Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic Value of the cancer antigen-125 in lung cancer	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	No
Secondary	The prognostic value of the cancer antigen-125 in lung cancer	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	No