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Application of Detecting Circulating Tumor Cells in the Accurate Treatment of Early Stage Lung Adenocarcinoma

Application of Detecting Circulating Tumor Cells in the Accurate Diagnosis and Treatment of Early Stage Lung Adenocarcinoma

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02951897
Acronym
CTCs detection
Enrollment
120
Registered
2016-11-01
Start date
2016-04-30
Completion date
2019-12-31
Last updated
2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulating Tumor Cells, Diagnoses Diseases, Lung Adenocarcinoma, Stage I, Treatment

Keywords

circulating tumor cells, lung adenocarcinoma, treatment, early diagnosis

Brief 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 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.

Interventions

PROCEDURElobectomy
PROCEDUREsegmentecomy
DRUGchemotherapy(pemetrexed+CISPLATIN)
PROCEDURELymphadenectomy

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.

OTHERCanPatrolTM to detect CTCs

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.

Sponsors

Third Military Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* stage I lung adenocarcinoma

Exclusion criteria

* cases with any new adjuvant treatment prior to surgery

Design outcomes

Primary

MeasureTime frame
Disease free survivalFrom date of diagnosis until the date of first documented progression or date of cancer related death , whichever came first, assessed up to 60 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026