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

NCT02951897 | Unknown DMC

• 1 other identifier: TMMU-DP-2016-4-25
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

circulating tumor cells; lung adenocarcinoma; treatment; early diagnosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (6)

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.

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.

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.

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.

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.

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.

Procedure: lobectomy; Procedure: Lymphadenectomy; Other: CanPatrolTM to detect CTCs

Interventions

lobectomy PROCEDURE

IA-CTC-High-controls; IA-CTC-High-enhance; IB-CTC-High-controls; IB-CTC-High-enhance; IB-CTC-low-controls

segmentecomy PROCEDURE

IA-CTC-low-controls

chemotherapy（pemetrexed+CISPLATIN） DRUG

IA-CTC-High-enhance; IB-CTC-High-enhance

Lymphadenectomy PROCEDURE

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.

IA-CTC-High-controls; IA-CTC-High-enhance; IB-CTC-High-controls; IB-CTC-High-enhance; IB-CTC-low-controls

CanPatrolTM to detect CTCs OTHER

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.

IA-CTC-High-controls; IA-CTC-High-enhance; IA-CTC-low-controls; IB-CTC-High-controls; IB-CTC-High-enhance; IB-CTC-low-controls

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stage I lung adenocarcinoma

You may not qualify if:

• cases with any new adjuvant treatment prior to surgery

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Daping hospital

Chongqing, China

RECRUITING

Related Publications (12)

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MeSH Terms

Conditions

Adenocarcinoma of Lung; Neoplastic Cells, Circulating; Disease

Interventions

Anterior Temporal Lobectomy; Lymph Node Excision

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Neurosurgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: November 1, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 2, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)