The Value Of Circulating Tumor Cells In Patient With NSCLC In Postoperative Recurrence Monitoring

Non-small-cell Lung Carcinoma Clinical Trial

Official title:

The Value Of Circulating Tumor Cells In Patient With NSCLC In Postoperative Recurrence Monitoring

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02647164
• Other study ID #: CTC2015-01
• Status: Not yet recruiting
• Phase: N/A
• First received: December 28, 2015
• Last updated: January 5, 2016
• Start date: January 2016

Study information

• Verified date: September 2015
• Source: GenoSaber
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess the value of circulating tumor cells (CTC)for non-small cell lung cancer in the postoperative recurrence monitoring by comparing the CTCs, CT and tumor markers at different time points.The time of CTC and carcinoembryonic antigen(CEA) detection is baseline, 2~7 days, 3 months, 6 months, 12 months, 24 months, 36 months after the surgery. And the time of CT detection is 6 months, 12 months, 24 months, 36 months after the surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80 years old

• Patients with histologically documented (stage ?/?/?A ) non-small cell lung cancer.

• Patients will undergo surgery.

• Patients with preoperative CTCs =8.5 Units / 3 ml

• Informed consent must be obtained from all patients prior to beginning therapy. Patients should have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Patients with histologically documented not (stage ?/?/?A ) non-small cell lung cancer.

• After the operation review, patients' result of CTC, CT and tumor markers is incomplete at the same point.

• The blood sample isn't collected in predetermined time.

• The blood samples appear hemolysis.

• The blood sample isn't enough.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplastic Cells, Circulating
• Non-small-cell Lung Carcinoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GenoSaber

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating tumor cells will be detected by Immunomagnetic negative screening and targeted PCR method.		3 years	No
Secondary	carcinoembryonic antigen(CEA) concentration will be detected by electrochemical luminescence.		3 years	No
Secondary	Liconography using conventional CT examination results.		3 years	No