Lung Cancer RecurrentNCT03721133
Recurrent Predictive Power of Circulating Tumor Cells for Non Small Cell Lung Cancer Patients
An observational study of Lung Cancer Recurrent, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
From literature review, circulating tumor cell was demonstrated its possible role in disease relapse. It was rare nit could be identified in all lung cancer patients. In addition, circulating tumor cell usual aggregate to form circulating tumor micro-emboli and caused distant metastases. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer Recurrent
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Dec 2018to 31 Dec 2024
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a resectable malignant or suspicious malignant pulmonary lesion
Who may be able to join
- Non-small cell lung cancer patients with stage I to III
- Patients with resectable suspicious pulmonary malignant lesion
- no pre-operation diagnosis ( patients refused biopsy or difficult for biopsy)
- image survey showed clinical stage I to III
Who cannot join
- Final pathology coexisted with small cell lung cancer component
- Patients who presented as stage IIIb or IV.
- Not received curative intended surgery due to multi-comorbidities.
- Patients who presented in tumor seeding or positive resection in the final pathology
- Patients who received neoadjuvant therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recurrent Predictive Power of Circulating Tumor Cells in Non Small Cell Lung Cancer Patients Who Receive Curative Resection
From literature review, circulating tumor cell was demonstrated its possible role in disease relapse. It was rare nit could be identified in all lung cancer patients. In addition, circulating tumor cell usual aggregate to form circulating tumor micro-emboli and caused distant metastases. Therefore, circulating tumor cell could play a role in detect disease relapse and appropriate treatment could be given more earlier and further prolong patients' survival. However, the detail clinical significance of circulating tumor still remains unknown. The aim of this study was evaluate the clinical significance, including present timing, numbers, and correlation to disease relapse, of circulating tumor cell in lung cancer patients. The investigators want to clarify the clinical significance between circulating tumor cell and clinical presentation of lung cancer in order to establish new prediction model and improve lung cancer patients' survival.
Read the detailed description
Study subject:
Inclusion criteria 1. Patients with clinical stage 1 to 3a non-small lung cancer 2. Patients with a resectable suspicious pulmonary lesion which is difficult for pre-operation tissue prove or refused for pre-operation biopsy 3. Received curative intended tumor resection Exclusion criteria
- Small cell lung cancer component which identified in pathology
- Patients who presented as stage IIIb or IV
- Not received curative intended surgery due to multi-comorbidities
- Patients who presented in tumor seeding or positive resection in pathology confirmation
- Patients who received neoadjuvant therapy
Data collection:
medical record review and blood sampling for circulating tumor cell purification
Timing of blood sampling:
a.Pre-operation, post-operation, post-operation day 1, post-operation day 3 b regular OPD surveillance (3 month-interval) for 3 years
Blood sampling: 20 ml blood that withdrawn from a peripheral vein
Circulating tumor cell purification: two-step procedure
- cell isolation: centrifugation, isolated karyocyte > 10 micrometer
- negative selection: wash out RBC, WBC depletion
- positive selection: purify circulating tumor cell (karyocyte which presented CD 45 negative, Epi-CAM positive, diameter greater 10 micrometer
Result analysis:
Combine the medical record to analyze the relationship between circulating tumor cells and disease relapse
- Conditions
- Lung Cancer Recurrent
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation trend of circulating tumor cell counts
Relationship between variation trend of circulating tumor cells and disease relapse in patients with a suspicious pulmonary lesion after tumor resection
Measured: 1. Circulating tumor cell counts in pre-op, post-op, post-operation day 1 and post-operation day 3 ; 2.need complete 5-years surveillance (disease status confirmation)
Validation of variation trend of circulating tumor cell counts
sequence patient recruitment for validation
Measured: 1. Circulating tumor cell counts in pre-op, post-op, post-operation day 1 and post-operation day 3 ; 2.model establish model (case 1 to 50) versus validation group ( case 51-120) 3. need complete 5-years surveillance (disease status confirmation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start4 Dec 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Hsun Hsieh, MD, Principal investigator, Chang Gung Memorial HospitalYi-Cheng Wu, MD, Principal investigator, Chang Gung Memorial HospitalCheng-Ta Yang, MD, Principal investigator, Chang Gung Memorial HospitalJUI-YING Fu, MD, Principal investigator, Chang Gung Memorial HospitalChingFeng Wu, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721133
- Sponsor's protocol ID
- 201701892B0
- Status last verified
- Mar 2024
- First submitted
- 22 Oct 2018
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fernandes G, Sucena M, Lombardia E, Machado A, Hespanhol V, Queiroga H. Non small cell lung cancer - comparison between clinical and pathological staging. Rev Port Pneumol. 2006 Jul-Aug;12(4):337-57. English, Portuguese.
PubMed 16969567McCann J. PET scans approved for detecting metastatic non-small-cell lung cancer. J Natl Cancer Inst. 1998 Jan 21;90(2):94-6. doi: 10.1093/jnci/90.2.94. No abstract available.
PubMed 9450567Vaz AP, Fernandes G, Souto Moura C, Bastos P, Queiroga H, Hespanhol V. Integrated PET/CT in non small cell lung cancer staging--clinical and pathological agreement. Rev Port Pneumol. 2012 May-Jun;18(3):109-14. doi: 10.1016/j.rppneu.2012.01.004. Epub 2012 Mar 8. English, Portuguese.
PubMed 22405953Wu CY, Fu JY, Wu CF, Hsieh MJ, Liu YH, Wu YC, Yang CT, Tsai YH. Survival Prediction Model Using Clinico-Pathologic Characteristics for Nonsmall Cell Lung Cancer Patients After Curative Resection. Medicine (Baltimore). 2015 Nov;94(45):e2013. doi: 10.1097/MD.0000000000002013.
PubMed 26559298Wu CY, Fu JY, Wu CF, Liu YH, Hsieh MJ, Wu YC, Yang CT, Tsai YH. Pathologic Stage of Nonsmall Cell Lung Cancer Patients Presenting as Resectable Cases After Neoadjuvant Therapy Did Not Predict the Prognosis. Medicine (Baltimore). 2015 Oct;94(40):1. doi: 10.1097/MD.0000000000001700.
PubMed 26448022Wu CF, Fu JY, Yeh CJ, Liu YH, Hsieh MJ, Wu YC, Wu CY, Tsai YH, Chou WC. Recurrence Risk Factors Analysis for Stage I Non-small Cell Lung Cancer. Medicine (Baltimore). 2015 Aug;94(32):e1337. doi: 10.1097/MD.0000000000001337.
PubMed 26266381Wu CF, Wu CY, Fu JY, Wang CW, Liu YH, Hsieh MJ, Wu YC. Prognostic value of metastatic N1 lymph node ratio and angiolymphatic invasion in patients with pathologic stage IIA non-small cell lung cancer. Medicine (Baltimore). 2014 Oct;93(20):e102. doi: 10.1097/MD.0000000000000102.
PubMed 25365403Hsieh CP, Fu JY, Liu YH, Yang CT, Hsieh MJ, Tsai YH, Wu YC, Wu CY. Prognostic factors in resectable pathological N2 disease of non-small cell lung cancer. Biomed J. 2015 Jul-Aug;38(4):329-35. doi: 10.4103/2319-4170.145765.
PubMed 25432594Tognela A, Spring KJ, Becker T, Caixeiro NJ, Bray VJ, Yip PY, Chua W, Lim SH, de Souza P. Predictive and prognostic value of circulating tumor cell detection in lung cancer: a clinician's perspective. Crit Rev Oncol Hematol. 2015 Feb;93(2):90-102. doi: 10.1016/j.critrevonc.2014.10.001. Epub 2014 Oct 12.
PubMed 25459665Tanaka F, Yoneda K, Kondo N, Hashimoto M, Takuwa T, Matsumoto S, Okumura Y, Rahman S, Tsubota N, Tsujimura T, Kuribayashi K, Fukuoka K, Nakano T, Hasegawa S. Circulating tumor cell as a diagnostic marker in primary lung cancer. Clin Cancer Res. 2009 Nov 15;15(22):6980-6. doi: 10.1158/1078-0432.CCR-09-1095. Epub 2009 Nov 3.
PubMed 19887487Pantel K, Speicher MR. The biology of circulating tumor cells. Oncogene. 2016 Mar 10;35(10):1216-24. doi: 10.1038/onc.2015.192. Epub 2015 Jun 8.
PubMed 26050619Yoon SO, Kim YT, Jung KC, Jeon YK, Kim BH, Kim CW. TTF-1 mRNA-positive circulating tumor cells in the peripheral blood predict poor prognosis in surgically resected non-small cell lung cancer patients. Lung Cancer. 2011 Feb;71(2):209-16. doi: 10.1016/j.lungcan.2010.04.017. Epub 2010 May 14.
PubMed 20471712O'Flaherty JD, Gray S, Richard D, Fennell D, O'Leary JJ, Blackhall FH, O'Byrne KJ. Circulating tumour cells, their role in metastasis and their clinical utility in lung cancer. Lung Cancer. 2012 Apr;76(1):19-25. doi: 10.1016/j.lungcan.2011.10.018. Epub 2011 Dec 29.
PubMed 22209049Hou JM, Greystoke A, Lancashire L, Cummings J, Ward T, Board R, Amir E, Hughes S, Krebs M, Hughes A, Ranson M, Lorigan P, Dive C, Blackhall FH. Evaluation of circulating tumor cells and serological cell death biomarkers in small cell lung cancer patients undergoing chemotherapy. Am J Pathol. 2009 Aug;175(2):808-16. doi: 10.2353/ajpath.2009.090078. Epub 2009 Jul 23.
PubMed 19628770Hofman V, Long E, Ilie M, Bonnetaud C, Vignaud JM, Flejou JF, Lantuejoul S, Piaton E, Mourad N, Butori C, Selva E, Marquette CH, Poudenx M, Sibon S, Kelhef S, Venissac N, Jais JP, Mouroux J, Molina TJ, Vielh P, Hofman P. Morphological analysis of circulating tumour cells in patients undergoing surgery for non-small cell lung carcinoma using the isolation by size of epithelial tumour cell (ISET) method. Cytopathology. 2012 Feb;23(1):30-8. doi: 10.1111/j.1365-2303.2010.00835.x. Epub 2011 Jan 6.
PubMed 21210876
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent Predictive Power of Circulating Tumor Cells in Non Small Cell Lung Cancer Patients Who Receive Curative Resection
- ClinicalTrials.gov ID
- NCT03721133
- Acronym / sponsor ID
- 201701892B0
- Conditions
- Lung Cancer Recurrent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Oct 2018 (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.
From literature review, circulating tumor cell was demonstrated its possible role in disease relapse. It was rare nit could be identified in all lung cancer patients. In addition, circulating tumor cell usual aggregate to form circulating tumor micro-emboli and caused distant metastases. Therefore, circulating tumor cell could play a role in detect disease relapse and appropriate treatment could be given more earlier and further prolong patients' survival. However, the detail clinical significance of circulating tumor still remains unknown. The aim of this study was evaluate the clinical significance, including present timing, numbers, and correlation to disease relapse, of circulating tumor cell in lung cancer patients. The investigators want to clarify the clinical significance between circulating tumor cell and clinical presentation of lung cancer in order to establish new prediction model and improve lung cancer patients' survival.
Detailed description
Study subject:
Inclusion criteria 1. Patients with clinical stage 1 to 3a non-small lung cancer 2. Patients with a resectable suspicious pulmonary lesion which is difficult for pre-operation tissue prove or refused for pre-operation biopsy 3. Received curative intended tumor resection Exclusion criteria
- Small cell lung cancer component which identified in pathology
- Patients who presented as stage IIIb or IV
- Not received curative intended surgery due to multi-comorbidities
- Patients who presented in tumor seeding or positive resection in pathology confirmation
- Patients who received neoadjuvant therapy
Data collection:
medical record review and blood sampling for circulating tumor cell purification
Timing of blood sampling:
a.Pre-operation, post-operation, post-operation day 1, post-operation day 3 b regular OPD surveillance (3 month-interval) for 3 years
Blood sampling: 20 ml blood that withdrawn from a peripheral vein
Circulating tumor cell purification: two-step procedure
- cell isolation: centrifugation, isolated karyocyte > 10 micrometer
- negative selection: wash out RBC, WBC depletion
- positive selection: purify circulating tumor cell (karyocyte which presented CD 45 negative, Epi-CAM positive, diameter greater 10 micrometer
Result analysis:
Combine the medical record to analyze the relationship between circulating tumor cells and disease relapse
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a resectable malignant or suspicious malignant pulmonary lesion
Key inclusion criteria (4 listed)
- Non-small cell lung cancer patients with stage I to III
- Patients with resectable suspicious pulmonary malignant lesion
Key exclusion criteria (5 listed)
- Final pathology coexisted with small cell lung cancer component
- Patients who presented as stage IIIb or IV.
- Not received curative intended surgery due to multi-comorbidities.
- Patients who presented in tumor seeding or positive resection in the final pathology
- Patients who received neoadjuvant therapy.
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
Variation trend of circulating tumor cell counts
Time frame: 1. Circulating tumor cell counts in pre-op, post-op, post-operation day 1 and post-operation day 3 ; 2.need complete 5-years surveillance (disease status confirmation)
Relationship between variation trend of circulating tumor cells and disease relapse in patients with a suspicious pulmonary lesion after tumor resection
Validation of variation trend of circulating tumor cell counts
Time frame: 1. Circulating tumor cell counts in pre-op, post-op, post-operation day 1 and post-operation day 3 ; 2.model establish model (case 1 to 50) versus validation group ( case 51-120) 3. need complete 5-years surveillance (disease status confirmation)
sequence patient recruitment for validation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Background: PubMed 16969567Fernandes G, Sucena M, Lombardia E, Machado A, Hespanhol V, Queiroga H. Non small cell lung cancer - comparison between clinical and pathological staging. Rev Port Pneumol. 2006 Jul-Aug;12(4):337-57. English, Portuguese.
- Background: PubMed 9450567McCann J. PET scans approved for detecting metastatic non-small-cell lung cancer. J Natl Cancer Inst. 1998 Jan 21;90(2):94-6. doi: 10.1093/jnci/90.2.94. No abstract available.
- Background: PubMed 22405953Vaz AP, Fernandes G, Souto Moura C, Bastos P, Queiroga H, Hespanhol V. Integrated PET/CT in non small cell lung cancer staging--clinical and pathological agreement. Rev Port Pneumol. 2012 May-Jun;18(3):109-14. doi: 10.1016/j.rppneu.2012.01.004. Epub 2012 Mar 8. English, Portuguese.
- Background: PubMed 26559298Wu CY, Fu JY, Wu CF, Hsieh MJ, Liu YH, Wu YC, Yang CT, Tsai YH. Survival Prediction Model Using Clinico-Pathologic Characteristics for Nonsmall Cell Lung Cancer Patients After Curative Resection. Medicine (Baltimore). 2015 Nov;94(45):e2013. doi: 10.1097/MD.0000000000002013.
- Background: PubMed 26448022Wu CY, Fu JY, Wu CF, Liu YH, Hsieh MJ, Wu YC, Yang CT, Tsai YH. Pathologic Stage of Nonsmall Cell Lung Cancer Patients Presenting as Resectable Cases After Neoadjuvant Therapy Did Not Predict the Prognosis. Medicine (Baltimore). 2015 Oct;94(40):1. doi: 10.1097/MD.0000000000001700.
- Background: PubMed 26266381Wu CF, Fu JY, Yeh CJ, Liu YH, Hsieh MJ, Wu YC, Wu CY, Tsai YH, Chou WC. Recurrence Risk Factors Analysis for Stage I Non-small Cell Lung Cancer. Medicine (Baltimore). 2015 Aug;94(32):e1337. doi: 10.1097/MD.0000000000001337.
- Background: PubMed 25365403Wu CF, Wu CY, Fu JY, Wang CW, Liu YH, Hsieh MJ, Wu YC. Prognostic value of metastatic N1 lymph node ratio and angiolymphatic invasion in patients with pathologic stage IIA non-small cell lung cancer. Medicine (Baltimore). 2014 Oct;93(20):e102. doi: 10.1097/MD.0000000000000102.
- Background: PubMed 25432594Hsieh CP, Fu JY, Liu YH, Yang CT, Hsieh MJ, Tsai YH, Wu YC, Wu CY. Prognostic factors in resectable pathological N2 disease of non-small cell lung cancer. Biomed J. 2015 Jul-Aug;38(4):329-35. doi: 10.4103/2319-4170.145765.
- Background: PubMed 25459665Tognela A, Spring KJ, Becker T, Caixeiro NJ, Bray VJ, Yip PY, Chua W, Lim SH, de Souza P. Predictive and prognostic value of circulating tumor cell detection in lung cancer: a clinician's perspective. Crit Rev Oncol Hematol. 2015 Feb;93(2):90-102. doi: 10.1016/j.critrevonc.2014.10.001. Epub 2014 Oct 12.
- Background: PubMed 19887487Tanaka F, Yoneda K, Kondo N, Hashimoto M, Takuwa T, Matsumoto S, Okumura Y, Rahman S, Tsubota N, Tsujimura T, Kuribayashi K, Fukuoka K, Nakano T, Hasegawa S. Circulating tumor cell as a diagnostic marker in primary lung cancer. Clin Cancer Res. 2009 Nov 15;15(22):6980-6. doi: 10.1158/1078-0432.CCR-09-1095. Epub 2009 Nov 3.
- Background: PubMed 26050619Pantel K, Speicher MR. The biology of circulating tumor cells. Oncogene. 2016 Mar 10;35(10):1216-24. doi: 10.1038/onc.2015.192. Epub 2015 Jun 8.
- Background: PubMed 20471712Yoon SO, Kim YT, Jung KC, Jeon YK, Kim BH, Kim CW. TTF-1 mRNA-positive circulating tumor cells in the peripheral blood predict poor prognosis in surgically resected non-small cell lung cancer patients. Lung Cancer. 2011 Feb;71(2):209-16. doi: 10.1016/j.lungcan.2010.04.017. Epub 2010 May 14.
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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.
Chia-Hsun Hsieh, MD principal investigator
Chang Gung Memorial Hospital
Yi-Cheng Wu, MD principal investigator
Chang Gung Memorial Hospital
Cheng-Ta Yang, MD principal investigator
Chang Gung Memorial Hospital
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 Recurrent, run by Chang Gung Memorial 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 4 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 22 May 2024. 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?
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?
Variation trend of circulating tumor cell counts (time frame: 1. Circulating tumor cell counts in pre-op, post-op, post-operation day 1 and post-operation day 3 ; 2.need complete 5-years surveillance (disease status confirmation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03721133, which also lists 23 linked publications.
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 22 May 2024.