NCT02437760

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

April 18, 2015

Last Update Submit

May 5, 2015

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • The diagnostic Value of the cancer antigen-125 in lung cancer

    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

    12months

Secondary Outcomes (1)

  • The prognostic value of the cancer antigen-125 in lung cancer

    24 months

Interventions

serum and pleural effusion CA-125 levelOTHER

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with histologically proved lung cancer

You may qualify if:

  • Histologically proved lung cancer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

E-DA hospital

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Jiun-Ting Wu, MD

CONTACT

886-07-6150011ed103621@edah.org.tw

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2015

First Posted

May 8, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2018

Last Updated

May 8, 2015

Record last verified: 2015-05

Locations

TW(1)