Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-02-21 @ 3:33 AM
Study NCT ID:
NCT03721133
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-22
First Post:
2018-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recurrent Predictive Power of Circulating Tumor Cells for Non Small Cell Lung Cancer Patients
Sponsor:
Chang Gung Memorial Hospital
Organization:
Study Overview
Official Title:
Recurrent Predictive Power of Circulating Tumor Cells in Non Small Cell Lung Cancer Patients Who Receive Curative Resection
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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
1. Small cell lung cancer component which identified in pathology
2. Patients who presented as stage IIIb or IV
3. Not received curative intended surgery due to multi-comorbidities
4. Patients who presented in tumor seeding or positive resection in pathology confirmation
5. 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
1. cell isolation: centrifugation, isolated karyocyte \> 10 micrometer
2. negative selection: wash out RBC, WBC depletion
3. 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
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
1. Small cell lung cancer component which identified in pathology
2. Patients who presented as stage IIIb or IV
3. Not received curative intended surgery due to multi-comorbidities
4. Patients who presented in tumor seeding or positive resection in pathology confirmation
5. 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
1. cell isolation: centrifugation, isolated karyocyte \> 10 micrometer
2. negative selection: wash out RBC, WBC depletion
3. 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: