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

Not Applicable

• Conditions: Lung Adenocarcinoma, Stage I; Diagnoses Diseases; Circulating Tumor Cells; Treatment
• Interventions: Procedure: lobectomy; Procedure: segmentecomy; Drug: chemotherapy（pemetrexed+CISPLATIN）; Procedure: Lymphadenectomy; Other: CanPatrolTM to detect CTCs

• Registration Number: NCT02951897
• Lead Sponsor: Third Military Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Status Verified: 2016-10
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-30
• Last Update Submitted: 2016-10-31
• Study First Posted: 2016-11-01
• Last Update Posted: 2016-11-02
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• stage I lung adenocarcinoma

Exclusion Criteria

• cases with any new adjuvant treatment prior to surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IA-CTC-High-enhance	lobectomy	IA 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-enhance	chemotherapy（pemetrexed+CISPLATIN）	IA 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-enhance	Lymphadenectomy	IA 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-enhance	CanPatrolTM to detect CTCs	IA 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	lobectomy	IA lung adenocarcinoma cases with high abundant CTCs prior to operation will only undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted.
IA-CTC-High-controls	Lymphadenectomy	IA lung adenocarcinoma cases with high abundant CTCs prior to operation will only undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted.
IA-CTC-High-controls	CanPatrolTM to detect CTCs	IA 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	segmentecomy	IA lung adenocarcinoma cases with low abundant CTCs prior to operation will only undergo segmentectomy. Postoperative CTC monitoring will be conducted.
IA-CTC-low-controls	CanPatrolTM to detect CTCs	IA lung adenocarcinoma cases with low abundant CTCs prior to operation will only undergo segmentectomy. Postoperative CTC monitoring will be conducted.
IB-CTC-High-enhance	lobectomy	IB 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-enhance	chemotherapy（pemetrexed+CISPLATIN）	IB 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-enhance	Lymphadenectomy	IB 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-enhance	CanPatrolTM to detect CTCs	IB 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	lobectomy	IB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted.
IB-CTC-High-controls	Lymphadenectomy	IB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted.
IB-CTC-High-controls	CanPatrolTM to detect CTCs	IB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted.
IB-CTC-low-controls	lobectomy	IB lung adenocarcinoma cases with low abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted.
IB-CTC-low-controls	Lymphadenectomy	IB lung adenocarcinoma cases with low abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted.
IB-CTC-low-controls	CanPatrolTM to detect CTCs	IB lung adenocarcinoma cases with low abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted.

Primary Outcome Measures

Name	Time	Method
Disease free survival	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

Trial Locations

Locations (1)

Daping hospital; 🇨🇳 Chongqing, China