Therapeutic and Prognostic Impact of Circulating Tumor Cells in Peripheral Blood in Patients With Non Small-cell Lung Cancer

Circulating Tumor Cells Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01052818
• Other study ID #: INCAN/OfCA204/SO151/CB451/09
• Secondary ID: 87453
• Status: Recruiting
• Phase: N/A
• First received: January 18, 2010
• Last updated: January 18, 2010
• Start date: July 2007

Study information

• Verified date: January 2010
• Source: National Institute of Cancerología
• Contact: Oscar Arrieta, MD
• Phone: (0155)56280400
• Email: ogar[@]servidor.unam.mx
• Is FDA regulated: No
• Health authority: Mexico: National Council of Science and Technology
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to evaluate the association between the number of circulating tumor cells and response to treatment in non small-cell lung cancer patients

Description:

In spite of technological advantages in diagnosis and treatment, lung cancer remains one of the most deadly malignant neoplasias. Moreover, there are no markers for monitoring response to treatment. The objective of the study is to associate the number of circulating tumor cells (CTC) before and after treatment and correlate it with tumor response rate, progression-free survival and overall survival.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histopathologic diagnosis of non small-cell lung cancer

• Clinical stage IV

• ECOG functional status 0 or 1

• No renal function alteration (GFR >50%)

• No hepatic function alteration (ALT and AST less than 2 times its normal value)

• Leucocytes more than 2,000/mcl

• Hemoglobin more than 10mg/dL

• Platelets more than 100,000/mcl

Exclusion Criteria:

Non-advanced disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Circulating Tumor Cells
• Neoplastic Cells, Circulating

Locations

Country	Name	City	State
Mexico	National Institute of Cancerologia	Mexico City	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cancerología

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate, progression-free survival and over-all survival		4 years	No
Secondary	Quantification of CTCs		4 years	No