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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by National Institute of Cancerología.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Cancerología
ClinicalTrials.gov Identifier:
NCT01052818
First received: January 18, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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
Circulating Tumor Cells

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by National Institute of Cancerología:

Primary Outcome Measures:
  • Response rate, progression-free survival and over-all survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quantification of CTCs [ Time Frame: 4 years ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 200
Study Start Date: July 2007
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stage IV NSCLC
Stage IV non small-cell lung cancer patients will be recruited for this protocol

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Oscar Arrieta Rodriguez, CONACyT
ClinicalTrials.gov Identifier: NCT01052818     History of Changes
Other Study ID Numbers: INCAN/OfCA204/SO151/CB451/09, 87453
Study First Received: January 18, 2010
Last Updated: January 18, 2010
Health Authority: Mexico: National Council of Science and Technology

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
Lung Neoplasms
Neoplastic Cells, Circulating
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014