Lung CancerNCT02437760
The Prognostic and Predictive Value of the CA-125 Marker in Lung Cancer Monitoring
An observational study of Lung Cancer, run by E-DA Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- serum and pleural effusion CA-125 level
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2015to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with histologically proved lung cancer
Who may be able to join
- Histologically proved lung cancer
Who cannot join
- History of other cancers within the past 5 years
- Pregnancy or breast milk feeding
- TB pleuritis and peritonitis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
E-DA hospital
Kaohsiung City
Jiun-Ting Wu, MD, 886-7-615-0011 ext. 5026, jt600729@ms13.hinet.net
Jiun-Ting Wu, MD
About this study
Official title: 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.
- Conditions
- Lung Cancer
- Being tested
- serum and pleural effusion CA-125 level
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12months
Secondary outcomes (1)
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- E-DA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437760
- Sponsor's protocol ID
- EMRP49103N
- Status last verified
- May 2015
- First submitted
- 18 Apr 2015
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Prognostic and Predictive Value of the Cancer Antigen-125 (CA-125) Marker in Lung Cancer Monitoring
- ClinicalTrials.gov ID
- NCT02437760
- Acronym / sponsor ID
- EMRP49103N
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- E-DA HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with histologically proved lung cancer
Key inclusion criteria (1 listed)
- Histologically proved lung cancer
Key exclusion criteria (3 listed)
- History of other cancers within the past 5 years
- Pregnancy or breast milk feeding
- TB pleuritis and peritonitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum and pleural effusion CA-125 levelserum 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 | Other | – |
Primary outcome
The diagnostic Value of the cancer antigen-125 in lung cancer
Time frame: 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
1 secondary outcome
The prognostic value of the cancer antigen-125 in lung cancer
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by E-DA Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiun-Ting Wu, MD (886-07-6150011 ext. 5026, ed103621@edah.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic Value of the cancer antigen-125 in lung cancer (time frame: 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015.