Lung Adenocarcinoma, Stage ICTCs detectionNCT02951897
Application of Detecting Circulating Tumor Cells in the Accurate Treatment of Early Stage Lung Adenocarcinoma
A study testing lobectomy, segmentecomy and chemotherapy（pemetrexed+CISPLATIN） in people with Lung Adenocarcinoma, Stage I and Diagnoses Diseases, run by Third Military Medical University at 1 site in China.
Trial summary
In 2015-2016, 224,390 cases were newly diagnosed with lung cancer in USA. Of all the cases, 83% are non-small cell lung cancer (NSCLC). Currently, the 5-year survival rate of NSCLC patients is 21%, and more than 25% of early stage NSCLC patients, who have undergone surgical treatment, will have a relapse or… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Lung Adenocarcinoma, Stage I, Diagnoses Diseases, Circulating Tumor Cells
- What is being tested?
- lobectomy, segmentecomy and chemotherapy（pemetrexed+CISPLATIN）
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Dec 2019
- Phase
- Interventional
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage I lung adenocarcinoma
Who cannot join
- cases with any new adjuvant treatment prior to surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Daping hospital
Chongqing
Bo Deng, +86-13637782166, deng.bo@dphospital.tmmu.edu.cn
About this study
Official title: Application of Detecting Circulating Tumor Cells in the Accurate Diagnosis and Treatment of Early Stage Lung Adenocarcinoma
In 2015-2016, 224,390 cases were newly diagnosed with lung cancer in USA. Of all the cases, 83% are non-small cell lung cancer (NSCLC). Currently, the 5-year survival rate of NSCLC patients is 21%, and more than 25% of early stage NSCLC patients, who have undergone surgical treatment, will have a relapse or progression.
Circulating tumor cells (CTCs), which shed from the primary tumor into the vasculature or lymphatics, can be regarded as a new prognostic factors of metastatic process. Thus far, CTCs-detection technologies can be divided into epithelial cell adhesion molecule (EpCAM)-based detection methods, e.g., the widely used CellSearch® and Adnatest®,and EpCAM-independent detection methods, e.g., ISET® and ScreenCell®. Herein, the investigators used a newly established approach, i.e., CanPatrolTM to detect CTCs in early stage lung Adenocarcinoma cases.
The investigator aim to explore whether CTCs detection prior to surgery can be contributive to the early diagnosis, or may help to predict the prognosis and guide the treatment strategy of early stage lung Adenocarcinoma.
- Being tested
- lobectomy, segmentecomy, chemotherapy（pemetrexed+CISPLATIN）, Lymphadenectomy, CanPatrolTM to detect CTCs
- Keywords
- circulating tumor cells, lung adenocarcinoma, treatment, early diagnosis
- Medical subject headings
- Adenocarcinoma of Lung, Neoplastic Cells, Circulating, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lobectomyProcedure or surgery
segmentecomyProcedure or surgery
chemotherapy（pemetrexed+CISPLATIN）Drug
LymphadenectomyProcedure or surgery
Lymphadenectomy or lymph node dissection is the surgical removal of one or more groups of lymph nodes. It is almost always performed as part of the surgical management of cancer. In a regional lymph node dissection, some of the lymph nodes in the tumor area are removed; in a radical lymph node dissection, most or all of the lymph nodes in the tumor area are removed.
CanPatrolTM to detect CTCsOther
CanPatrol TM was used to detect CTCs, which is a newly established technology to detect CTCs, containing the following steps: (1) To remove erythrocytes by red blood cell lysis and deplete CD45+ leukocytes in 10ml blood sample using a magnetic bead separation method; (2) To enrich CTCs by 8-μm-diameter-pore calibrated membrane filters; and (3) To identify and characterize CTCs by using RNA-in situ hybridization (ISH), based on the branched DNA (bDNA) signal amplification technology, to detect EMT markers, e.g., cytokeratins(CK) 8, 18 and 19, epithelial cell adhesion molecule (EpCAM), vimentin and twist. The details of classification of CTCs by using CanPatrol TM was depicted in the recently published protocol. Finally, the CTCs were clustered into three subtypes, as per the EMT markers, i.e., epithelial (E-) CTCs, mesenchymal (M-) CTCs and epithelial- mesenchymal (E\&M-) CTCs.
| Study group | Role | What they receive |
|---|---|---|
| IA-CTC-High-enhance | Active comparator | IA lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy plus adjuvant chemotherapy. Postoperative CTC monitoring will be conducted. Receives: Procedure: lobectomy; Drug: chemotherapy（pemetrexed+CISPLATIN）; Procedure: Lymphadenectomy; Other: CanPatrolTM to detect CTCs |
| IA-CTC-High-controls | Placebo comparator | IA lung adenocarcinoma cases with high abundant CTCs prior to operation will only undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted. Receives: Procedure: lobectomy; Procedure: Lymphadenectomy; Other: CanPatrolTM to detect CTCs |
| IA-CTC-low-controls | Placebo comparator | IA lung adenocarcinoma cases with low abundant CTCs prior to operation will only undergo segmentectomy. Postoperative CTC monitoring will be conducted. Receives: Procedure: segmentecomy; Other: CanPatrolTM to detect CTCs |
| IB-CTC-High-enhance | Active comparator | IB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy plus adjuvant chemotherapy. Postoperative CTC monitoring will be conducted. Receives: Procedure: lobectomy; Drug: chemotherapy（pemetrexed+CISPLATIN）; Procedure: Lymphadenectomy; Other: CanPatrolTM to detect CTCs |
| IB-CTC-High-controls | Placebo comparator | IB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted. Receives: Procedure: lobectomy; Procedure: Lymphadenectomy; Other: CanPatrolTM to detect CTCs |
| IB-CTC-low-controls | Placebo comparator | IB lung adenocarcinoma cases with low abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted. Receives: Procedure: lobectomy; Procedure: Lymphadenectomy; Other: CanPatrolTM to detect CTCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: From date of diagnosis until the date of first documented progression or date of cancer related death , whichever came first, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Lung Adenocarcinoma, Stage IStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deng Bo, MD, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951897
- Sponsor's protocol ID
- TMMU-DP-2016-4-25
- Acronym
- CTCs detection
- Status last verified
- Oct 2016
- First submitted
- 25 Oct 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hofman V, Bonnetaud C, Ilie MI, Vielh P, Vignaud JM, Flejou JF, Lantuejoul S, Piaton E, Mourad N, Butori C, Selva E, Poudenx M, Sibon S, Kelhef S, Venissac N, Jais JP, Mouroux J, Molina TJ, Hofman P. Preoperative circulating tumor cell detection using the isolation by size of epithelial tumor cell method for patients with lung cancer is a new prognostic biomarker. Clin Cancer Res. 2011 Feb 15;17(4):827-35. doi: 10.1158/1078-0432.CCR-10-0445. Epub 2010 Nov 23.
PubMed 21098695Bayarri-Lara C, Ortega FG, Cueto Ladron de Guevara A, Puche JL, Ruiz Zafra J, de Miguel-Perez D, Ramos AS, Giraldo-Ospina CF, Navajas Gomez JA, Delgado-Rodriguez M, Lorente JA, Serrano MJ. Circulating Tumor Cells Identify Early Recurrence in Patients with Non-Small Cell Lung Cancer Undergoing Radical Resection. PLoS One. 2016 Feb 25;11(2):e0148659. doi: 10.1371/journal.pone.0148659. eCollection 2016.
PubMed 26913536Sawabata N, Okumura M, Utsumi T, Inoue M, Shiono H, Minami M, Nishida T, Sawa Y. Circulating tumor cells in peripheral blood caused by surgical manipulation of non-small-cell lung cancer: pilot study using an immunocytology method. Gen Thorac Cardiovasc Surg. 2007 May;55(5):189-92. doi: 10.1007/s11748-007-0101-2.
PubMed 17554991Hofman V, Ilie MI, Long E, Selva E, Bonnetaud C, Molina T, Venissac N, Mouroux J, Vielh P, Hofman P. Detection of circulating tumor cells as a prognostic factor in patients undergoing radical surgery for non-small-cell lung carcinoma: comparison of the efficacy of the CellSearch Assay and the isolation by size of epithelial tumor cell method. Int J Cancer. 2011 Oct 1;129(7):1651-60. doi: 10.1002/ijc.25819. Epub 2011 Mar 11.
PubMed 21128227Liu L, Liao GQ, He P, Zhu H, Liu PH, Qu YM, Song XM, Xu QW, Gao Q, Zhang Y, Chen WF, Yin YH. Detection of circulating cancer cells in lung cancer patients with a panel of marker genes. Biochem Biophys Res Commun. 2008 Aug 8;372(4):756-60. doi: 10.1016/j.bbrc.2008.05.101. Epub 2008 Jun 2.
PubMed 18514066Yamashita JI, Kurusu Y, Fujino N, Saisyoji T, Ogawa M. Detection of circulating tumor cells in patients with non-small cell lung cancer undergoing lobectomy by video-assisted thoracic surgery: a potential hazard for intraoperative hematogenous tumor cell dissemination. J Thorac Cardiovasc Surg. 2000 May;119(5):899-905. doi: 10.1016/S0022-5223(00)70084-5.
PubMed 10788810Nair VS, Keu KV, Luttgen MS, Kolatkar A, Vasanawala M, Kuschner W, Bethel K, Iagaru AH, Hoh C, Shrager JB, Loo BW Jr, Bazhenova L, Nieva J, Gambhir SS, Kuhn P. An observational study of circulating tumor cells and (18)F-FDG PET uptake in patients with treatment-naive non-small cell lung cancer. PLoS One. 2013 Jul 5;8(7):e67733. doi: 10.1371/journal.pone.0067733. Print 2013.
PubMed 23861795Yoon 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 20471712Chen X, Wang X, He H, Liu Z, Hu JF, Li W. Combination of circulating tumor cells with serum carcinoembryonic antigen enhances clinical prediction of non-small cell lung cancer. PLoS One. 2015 May 21;10(5):e0126276. doi: 10.1371/journal.pone.0126276. eCollection 2015.
PubMed 25996878Yie SM, Lou B, Ye SR, He X, Cao M, Xie K, Ye NY, Lin R, Wu SM, Xiao HB, Gao E. Clinical significance of detecting survivin-expressing circulating cancer cells in patients with non-small cell lung cancer. Lung Cancer. 2009 Feb;63(2):284-90. doi: 10.1016/j.lungcan.2008.05.024. Epub 2008 Jul 7.
PubMed 18606477Funaki S, Sawabata N, Nakagiri T, Shintani Y, Inoue M, Kadota Y, Minami M, Okumura M. Novel approach for detection of isolated tumor cells in pulmonary vein using negative selection method: morphological classification and clinical implications. Eur J Cardiothorac Surg. 2011 Aug;40(2):322-7. doi: 10.1016/j.ejcts.2010.11.029. Epub 2011 Jan 7.
PubMed 21215651Yin J, Wang Y, Yin H, Chen W, Jin G, Ma H, Dai J, Chen J, Jiang Y, Wang H, Liu Z, Hu Z, Shen H. Circulating Tumor Cells Enriched by the Depletion of Leukocytes with Bi-Antibodies in Non-Small Cell Lung Cancer: Potential Clinical Application. PLoS One. 2015 Aug 28;10(8):e0137076. doi: 10.1371/journal.pone.0137076. eCollection 2015.
PubMed 26317979
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Detecting Circulating Tumor Cells in the Accurate Diagnosis and Treatment of Early Stage Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02951897
- Acronym / sponsor ID
- CTCs detection / TMMU-DP-2016-4-25
- Keywords
- circulating tumor cells, lung adenocarcinoma, treatment, early diagnosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 Nov 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.
In 2015-2016, 224,390 cases were newly diagnosed with lung cancer in USA. Of all the cases, 83% are non-small cell lung cancer (NSCLC). Currently, the 5-year survival rate of NSCLC patients is 21%, and more than 25% of early stage NSCLC patients, who have undergone surgical treatment, will have a relapse or progression.
Circulating tumor cells (CTCs), which shed from the primary tumor into the vasculature or lymphatics, can be regarded as a new prognostic factors of metastatic process. Thus far, CTCs-detection technologies can be divided into epithelial cell adhesion molecule (EpCAM)-based detection methods, e.g., the widely used CellSearch® and Adnatest®,and EpCAM-independent detection methods, e.g., ISET® and ScreenCell®. Herein, the investigators used a newly established approach, i.e., CanPatrolTM to detect CTCs in early stage lung Adenocarcinoma cases.
The investigator aim to explore whether CTCs detection prior to surgery can be contributive to the early diagnosis, or may help to predict the prognosis and guide the treatment strategy of early stage lung Adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| IA-CTC-High-enhance | Active comparator | Procedure: lobectomy, Drug: chemotherapy（pemetrexed+CISPLATIN）, Procedure: Lymphadenectomy, Other: CanPatrolTM to detect CTCsIA lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy plus adjuvant chemotherapy. Postoperative CTC monitoring will be conducted. |
| IA-CTC-High-controls | Placebo comparator | Procedure: lobectomy, Procedure: Lymphadenectomy, Other: CanPatrolTM to detect CTCsIA lung adenocarcinoma cases with high abundant CTCs prior to operation will only undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted. |
| IA-CTC-low-controls | Placebo comparator | Procedure: segmentecomy, Other: CanPatrolTM to detect CTCsIA lung adenocarcinoma cases with low abundant CTCs prior to operation will only undergo segmentectomy. Postoperative CTC monitoring will be conducted. |
| IB-CTC-High-enhance | Active comparator | Procedure: lobectomy, Drug: chemotherapy（pemetrexed+CISPLATIN）, Procedure: Lymphadenectomy, Other: CanPatrolTM to detect CTCsIB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy plus adjuvant chemotherapy. Postoperative CTC monitoring will be conducted. |
| IB-CTC-High-controls | Placebo comparator | Procedure: lobectomy, Procedure: Lymphadenectomy, Other: CanPatrolTM to detect CTCsIB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted. |
| IB-CTC-low-controls | Placebo comparator | Procedure: lobectomy, Procedure: Lymphadenectomy, Other: CanPatrolTM to detect CTCsIB lung adenocarcinoma cases with low abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stage I lung adenocarcinoma
Key exclusion criteria (1 listed)
- cases with any new adjuvant treatment prior to surgery
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 |
|---|---|---|
| lobectomy | Procedure or surgery | IA-CTC-High-controls, IA-CTC-High-enhance, IB-CTC-High-controls, IB-CTC-High-enhance, IB-CTC-low-controls |
| segmentecomy | Procedure or surgery | IA-CTC-low-controls |
| chemotherapy（pemetrexed+CISPLATIN） | Drug | IA-CTC-High-enhance, IB-CTC-High-enhance |
| LymphadenectomyLymphadenectomy or lymph node dissection is the surgical removal of one or more groups of lymph nodes. It is almost always performed as part of the surgical management of cancer. In a regional lymph node dissection, some of the lymph nodes in the tumor area are removed; in a radical lymph node dissection, most or all of the lymph nodes in the tumor area are removed. | Procedure or surgery | IA-CTC-High-controls, IA-CTC-High-enhance, IB-CTC-High-controls, IB-CTC-High-enhance, IB-CTC-low-controls |
| CanPatrolTM to detect CTCsCanPatrol TM was used to detect CTCs, which is a newly established technology to detect CTCs, containing the following steps: (1) To remove erythrocytes by red blood cell lysis and deplete CD45+ leukocytes in 10ml blood sample using a magnetic bead separation method; (2) To enrich CTCs by 8-μm-diameter-pore calibrated membrane filters; and (3) To identify and characterize CTCs by using RNA-in situ hybridization (ISH), based on the branched DNA (bDNA) signal amplification technology, to detect EMT markers, e.g., cytokeratins(CK) 8, 18 and 19, epithelial cell adhesion molecule (EpCAM), vimentin and twist. The details of classification of CTCs by using CanPatrol TM was depicted in the recently published protocol. Finally, the CTCs were clustered into three subtypes, as per the EMT markers, i.e., epithelial (E-) CTCs, mesenchymal (M-) CTCs and epithelial- mesenchymal (E\&M-) CTCs. | Other | IA-CTC-High-controls, IA-CTC-High-enhance, IA-CTC-low-controls, IB-CTC-High-controls, IB-CTC-High-enhance, IB-CTC-low-controls |
Primary outcome
Disease free survival
Time frame: From date of diagnosis until the date of first documented progression or date of cancer related death , whichever came first, assessed up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Background: PubMed 21098695Hofman V, Bonnetaud C, Ilie MI, Vielh P, Vignaud JM, Flejou JF, Lantuejoul S, Piaton E, Mourad N, Butori C, Selva E, Poudenx M, Sibon S, Kelhef S, Venissac N, Jais JP, Mouroux J, Molina TJ, Hofman P. Preoperative circulating tumor cell detection using the isolation by size of epithelial tumor cell method for patients with lung cancer is a new prognostic biomarker. Clin Cancer Res. 2011 Feb 15;17(4):827-35. doi: 10.1158/1078-0432.CCR-10-0445. Epub 2010 Nov 23.
- Background: PubMed 26913536Bayarri-Lara C, Ortega FG, Cueto Ladron de Guevara A, Puche JL, Ruiz Zafra J, de Miguel-Perez D, Ramos AS, Giraldo-Ospina CF, Navajas Gomez JA, Delgado-Rodriguez M, Lorente JA, Serrano MJ. Circulating Tumor Cells Identify Early Recurrence in Patients with Non-Small Cell Lung Cancer Undergoing Radical Resection. PLoS One. 2016 Feb 25;11(2):e0148659. doi: 10.1371/journal.pone.0148659. eCollection 2016.
- Background: PubMed 17554991Sawabata N, Okumura M, Utsumi T, Inoue M, Shiono H, Minami M, Nishida T, Sawa Y. Circulating tumor cells in peripheral blood caused by surgical manipulation of non-small-cell lung cancer: pilot study using an immunocytology method. Gen Thorac Cardiovasc Surg. 2007 May;55(5):189-92. doi: 10.1007/s11748-007-0101-2.
- Background: PubMed 21128227Hofman V, Ilie MI, Long E, Selva E, Bonnetaud C, Molina T, Venissac N, Mouroux J, Vielh P, Hofman P. Detection of circulating tumor cells as a prognostic factor in patients undergoing radical surgery for non-small-cell lung carcinoma: comparison of the efficacy of the CellSearch Assay and the isolation by size of epithelial tumor cell method. Int J Cancer. 2011 Oct 1;129(7):1651-60. doi: 10.1002/ijc.25819. Epub 2011 Mar 11.
- Background: PubMed 18514066Liu L, Liao GQ, He P, Zhu H, Liu PH, Qu YM, Song XM, Xu QW, Gao Q, Zhang Y, Chen WF, Yin YH. Detection of circulating cancer cells in lung cancer patients with a panel of marker genes. Biochem Biophys Res Commun. 2008 Aug 8;372(4):756-60. doi: 10.1016/j.bbrc.2008.05.101. Epub 2008 Jun 2.
- Background: PubMed 10788810Yamashita JI, Kurusu Y, Fujino N, Saisyoji T, Ogawa M. Detection of circulating tumor cells in patients with non-small cell lung cancer undergoing lobectomy by video-assisted thoracic surgery: a potential hazard for intraoperative hematogenous tumor cell dissemination. J Thorac Cardiovasc Surg. 2000 May;119(5):899-905. doi: 10.1016/S0022-5223(00)70084-5.
- Background: PubMed 23861795Nair VS, Keu KV, Luttgen MS, Kolatkar A, Vasanawala M, Kuschner W, Bethel K, Iagaru AH, Hoh C, Shrager JB, Loo BW Jr, Bazhenova L, Nieva J, Gambhir SS, Kuhn P. An observational study of circulating tumor cells and (18)F-FDG PET uptake in patients with treatment-naive non-small cell lung cancer. PLoS One. 2013 Jul 5;8(7):e67733. doi: 10.1371/journal.pone.0067733. Print 2013.
- 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.
- Background: PubMed 25996878Chen X, Wang X, He H, Liu Z, Hu JF, Li W. Combination of circulating tumor cells with serum carcinoembryonic antigen enhances clinical prediction of non-small cell lung cancer. PLoS One. 2015 May 21;10(5):e0126276. doi: 10.1371/journal.pone.0126276. eCollection 2015.
- Background: PubMed 18606477Yie SM, Lou B, Ye SR, He X, Cao M, Xie K, Ye NY, Lin R, Wu SM, Xiao HB, Gao E. Clinical significance of detecting survivin-expressing circulating cancer cells in patients with non-small cell lung cancer. Lung Cancer. 2009 Feb;63(2):284-90. doi: 10.1016/j.lungcan.2008.05.024. Epub 2008 Jul 7.
- Background: PubMed 21215651Funaki S, Sawabata N, Nakagiri T, Shintani Y, Inoue M, Kadota Y, Minami M, Okumura M. Novel approach for detection of isolated tumor cells in pulmonary vein using negative selection method: morphological classification and clinical implications. Eur J Cardiothorac Surg. 2011 Aug;40(2):322-7. doi: 10.1016/j.ejcts.2010.11.029. Epub 2011 Jan 7.
- Background: PubMed 26317979Yin J, Wang Y, Yin H, Chen W, Jin G, Ma H, Dai J, Chen J, Jiang Y, Wang H, Liu Z, Hu Z, Shen H. Circulating Tumor Cells Enriched by the Depletion of Leukocytes with Bi-Antibodies in Non-Small Cell Lung Cancer: Potential Clinical Application. PLoS One. 2015 Aug 28;10(8):e0137076. doi: 10.1371/journal.pone.0137076. eCollection 2015.
- Individual participant dataSharing planned: No
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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?
A study testing lobectomy, segmentecomy and chemotherapy（pemetrexed+CISPLATIN） in people with Lung Adenocarcinoma, Stage I and Diagnoses Diseases, run by Third Military Medical University at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 2 Nov 2016. 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 China. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: From date of diagnosis until the date of first documented progression or date of cancer related death , whichever came first, assessed up to 60 months). 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 NCT02951897, which also lists 12 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 2 Nov 2016.