Non-small-cell Lung CarcinomaNCT02647164
The Value Of Circulating Tumor Cells In Patient With NSCLC In Postoperative Recurrence Monitoring
An observational study of Non-small-cell Lung Carcinoma, run by GenoSaber.
Trial summary
The purpose of this study is to assess the value of circulating tumor cells (CTC)for non-small cell lung cancer in the postoperative recurrence monitoring by comparing the CTCs, CT and tumor markers at different time points.The time of CTC and carcinoembryonic antigen(CEA) detection is baseline, 2~7 days, 3 months, 6… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-small-cell Lung Carcinoma
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Sep 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with NSCLC(stage Ⅰ/Ⅱ/ⅢA), who will receive operation.
Who may be able to join
- Age 18-80 years old
- Patients with histologically documented (stage Ⅰ/Ⅱ/ⅢA ) non-small cell lung cancer.
- Patients will undergo surgery.
- Patients with preoperative CTCs ≥8.5 Units / 3 ml
- Informed consent must be obtained from all patients prior to beginning therapy. Patients should have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients with histologically documented not (stage Ⅰ/Ⅱ/ⅢA ) non-small cell lung cancer.
- After the operation review, patients' result of CTC, CT and tumor markers is incomplete at the same point.
- The blood sample isn't collected in predetermined time.
- The blood samples appear hemolysis.
- The blood sample isn't enough.
About this study
The purpose of this study is to assess the value of circulating tumor cells (CTC)for non-small cell lung cancer in the postoperative recurrence monitoring by comparing the CTCs, CT and tumor markers at different time points.The time of CTC and carcinoembryonic antigen(CEA) detection is baseline, 2~7 days, 3 months, 6 months, 12 months, 24 months, 36 months after the surgery. And the time of CT detection is 6 months, 12 months, 24 months, 36 months after the surgery.
- Conditions
- Non-small-cell Lung Carcinoma
- Keywords
- Non-small-cell lung carcinoma, Circulating tumor cells
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplastic Cells, Circulating
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating tumor cells will be detected by Immunomagnetic negative screening and targeted PCR method.
Measured: 3 years
Secondary outcomes (2)
carcinoembryonic antigen(CEA) concentration will be detected by electrochemical luminescence.
Measured: 3 years
Liconography using conventional CT examination results.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small-cell Lung CarcinomaStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GenoSaber
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647164
- Sponsor's protocol ID
- CTC2015-01
- Status last verified
- Sep 2015
- First submitted
- 28 Dec 2015
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value Of Circulating Tumor Cells In Patient With NSCLC In Postoperative Recurrence Monitoring
- ClinicalTrials.gov ID
- NCT02647164
- Acronym / sponsor ID
- CTC2015-01
- Conditions
- Non-small-cell Lung Carcinoma
- Keywords
- Non-small-cell lung carcinoma, Circulating tumor cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- GenoSaberIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Sep 2018 (estimated)
- First posted
- 6 Jan 2016 (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 purpose of this study is to assess the value of circulating tumor cells (CTC)for non-small cell lung cancer in the postoperative recurrence monitoring by comparing the CTCs, CT and tumor markers at different time points.The time of CTC and carcinoembryonic antigen(CEA) detection is baseline, 2~7 days, 3 months, 6 months, 12 months, 24 months, 36 months after the surgery. And the time of CT detection is 6 months, 12 months, 24 months, 36 months after the surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NSCLC(stage Ⅰ/Ⅱ/ⅢA), who will receive operation.
Key inclusion criteria (5 listed)
- Age 18-80 years old
- Patients with histologically documented (stage Ⅰ/Ⅱ/ⅢA ) non-small cell lung cancer.
- Patients will undergo surgery.
- Patients with preoperative CTCs ≥8.5 Units / 3 ml
- Informed consent must be obtained from all patients prior to beginning therapy. Patients should have the ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (5 listed)
- Patients with histologically documented not (stage Ⅰ/Ⅱ/ⅢA ) non-small cell lung cancer.
- After the operation review, patients' result of CTC, CT and tumor markers is incomplete at the same point.
- The blood sample isn't collected in predetermined time.
- The blood samples appear hemolysis.
- The blood sample isn't enough.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Circulating tumor cells will be detected by Immunomagnetic negative screening and targeted PCR method.
Time frame: 3 years
2 secondary outcomes
carcinoembryonic antigen(CEA) concentration will be detected by electrochemical luminescence.
Time frame: 3 years
Liconography using conventional CT examination results.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small-cell Lung Carcinoma, run by GenoSaber.
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 5 inclusion and 5 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 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating tumor cells will be detected by Immunomagnetic negative screening and targeted PCR method. (time frame: 3 years). 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 6 Jan 2016.