Non Small Cell Lung CancerNCT05619562
Clinical Significance of Circulating Tumour Cells in Resectable Lung Cancer Patients
An observational study of Non Small Cell Lung Cancer and Circulating Tumor Cell, run by The Institute of Molecular and Translational Medicine, Czech Republic at 1 site in Czechia.
Trial summary
To determine whether the presence of circulating/disseminated tumour cells (CTCs/DTCs) in the blood and bone marrow of the resectable lung cancer (NSCLC) patients is a negative prognostic factor, and to find correlations with other clinical/pathological disease characteristics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Circulating Tumor Cell
- What is being tested?
- Device for CTC/DTC detection
- How many people
- 166 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2009to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed non-metastatic NSCLC undergoing radical surgery with curative intent.
Who may be able to join
- Non-small cell lung cancer, non-metastatic
Who cannot join
- Prior neoadjuvant chemoradiotherapy Prior lung cancer Cancer duplicity
Trial locations and contacts
1 site in 1 country.
About this study
To determine whether the presence of circulating/disseminated tumour cells (CTCs/DTCs) in the blood and bone marrow of the resectable lung cancer (NSCLC) patients is a negative prognostic factor, and to find correlations with other clinical/pathological disease characteristics.
- Conditions
- Non Small Cell Lung Cancer, Circulating Tumor Cell
- Being tested
- Device for CTC/DTC detection
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device for CTC/DTC detectionDiagnostic test
The CTCs/DTCs will be detected and counted in peripheral blood, tumour draining blood and bone marrow samples.
What is being measured
The primary outcome is the main question the study is designed to answer.
CEA, EGFR, LunX, c-met and EpCAM mRNA positive circulating tumour cells in lung cancer patients
The absolute gene expression of CEA, EGFR, LunX, c-met and EpCAM mRNA positive circulating tumour cells(CTCs) isolated from peripheral blood, tumour draining blood and bone marrow samples of lung cancer patients will be measured using real-time RT-PCR method. The gene expression will be normalized per microgram of total mRNA.
Measured: 30 days
Secondary outcomes (1)
Cancer specific survival in CTC positive NSCLC patients
The cancer specific survival, overall survival and disease free survival will be measured from the time of diagnosis to the time of event. Two groups of patients will be compared:
A: Patients with the presence of CTCs in peripheral blood, tumour draining blood and bone marrow before NSCLC surgery as described in primary outcome measure.
B: Patients with the absence e of CTCs in peripheral blood, tumour draining blood and bone marrow before NSCLC surgery as described in primary outcome measure.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study startJan 2009
- Primary completionApr 2013
- Study completionDec 2015
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 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marian Hajduch, M.D., Ph.D., The Institute of Molecular and Translational Medicine, Czech Republic
- Investigators
- Marian Hajduch, MD, PhD, Study director, Institute of Molecular and Translational Medicine, Faculty of Medicine and Dentistry, Palacky University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619562
- Sponsor's protocol ID
- NS10285
- Status last verified
- Nov 2022
- First submitted
- 9 Nov 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The anonymized metadata will be publicly available after publishing the results.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Circulating Tumour Cells in Resectable Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT05619562
- Acronym / sponsor ID
- NS10285
- Conditions
- Non Small Cell Lung Cancer, Circulating Tumor Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech RepublicUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Nov 2022 (actual)
- 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.
To determine whether the presence of circulating/disseminated tumour cells (CTCs/DTCs) in the blood and bone marrow of the resectable lung cancer (NSCLC) patients is a negative prognostic factor, and to find correlations with other clinical/pathological disease characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed non-metastatic NSCLC undergoing radical surgery with curative intent.
Key inclusion criteria (1 listed)
- Non-small cell lung cancer, non-metastatic
Key exclusion criteria (1 listed)
- Prior neoadjuvant chemoradiotherapy Prior lung cancer Cancer duplicity
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 |
|---|---|---|
| Device for CTC/DTC detectionThe CTCs/DTCs will be detected and counted in peripheral blood, tumour draining blood and bone marrow samples. | Diagnostic test | – |
Primary outcome
CEA, EGFR, LunX, c-met and EpCAM mRNA positive circulating tumour cells in lung cancer patients
Time frame: 30 days
The absolute gene expression of CEA, EGFR, LunX, c-met and EpCAM mRNA positive circulating tumour cells(CTCs) isolated from peripheral blood, tumour draining blood and bone marrow samples of lung cancer patients will be measured using real-time RT-PCR method. The gene expression will be normalized per microgram of total mRNA.
1 secondary outcome
Cancer specific survival in CTC positive NSCLC patients
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: No. The anonymized metadata will be publicly available after publishing the results.
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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.
Marian Hajduch, MD, PhD study director
Institute of Molecular and Translational Medicine, Faculty of Medicine and Dentistry, Palacky University
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 Non Small Cell Lung Cancer and Circulating Tumor Cell, run by The Institute of Molecular and Translational Medicine, Czech Republic at 1 site in Czechia.
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 1 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: finished, as of the sponsor's last update on 17 Nov 2022. 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CEA, EGFR, LunX, c-met and EpCAM mRNA positive circulating tumour cells in lung cancer patients (time frame: 30 days). 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 17 Nov 2022.