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

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ClinicalTrials.gov Identifier: NCT01052818
Recruitment Status : Unknown
Verified January 2010 by National Institute of Cancerología.
Recruitment status was:  Recruiting
First Posted : January 20, 2010
Last Update Posted : January 20, 2010
Sponsor:
Information provided by:

Study Description
Brief 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

Condition or disease
Circulating Tumor Cells

Detailed 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.

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : July 2007
Estimated Primary Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Stage IV NSCLC
Stage IV non small-cell lung cancer patients will be recruited for this protocol


Outcome Measures

Primary Outcome Measures :
  1. Response rate, progression-free survival and over-all survival [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Quantification of CTCs [ Time Frame: 4 years ]

Biospecimen Retention:   Samples With DNA
Peripheral blood samples are collected were the cell pellet are collected from centrifugation, lysed by TRIzol method to get RNA. The RNA is retrotranscribed to cDNA in order to quantify cytokeratin (CK) 19, 18 and carcinoembrionic antigen which are markers of epithelial cells presumambly coming form the tumor.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Advanced non small-cell lung cancer
Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01052818


Contacts
Contact: Oscar Arrieta, MD (0155)56280400 ext 832 ogar@servidor.unam.mx

Locations
Mexico
National Institute of Cancerologia Recruiting
Mexico City, Distrito Federal, Mexico, 14080
Contact: Oscar Arrieta, MD    (0155)56280400 ext 832    ogar@servidor.unam.mx   
Principal Investigator: Oscar Arrieta, MD         
Sponsors and Collaborators
National Institute of Cancerología
Investigators
Principal Investigator: Oscar Arrieta, MD National Counsil of Science and Technology
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oscar Arrieta Rodriguez, CONACyT
ClinicalTrials.gov Identifier: NCT01052818     History of Changes
Other Study ID Numbers: INCAN/OfCA204/SO151/CB451/09
87453 ( Other Identifier: National Counsil of Science and Technology )
First Posted: January 20, 2010    Key Record Dates
Last Update Posted: January 20, 2010
Last Verified: January 2010

Keywords provided by National Institute of Cancerología:
Non small-cell lung cancer
Circulating tumor cells
Carcinoembryonic antigen
Cytokeratin

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Neoplastic Cells, Circulating
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes