Therapeutic and Prognostic Impact of Circulating Tumor Cells in Peripheral Blood in Patients With Non Small-cell Lung Cancer
Recruitment status was Recruiting
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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 |
- Response rate, progression-free survival and over-all survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- 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 |
|---|
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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 |
Advanced non small-cell lung cancer
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| Contact: Oscar Arrieta, MD | (0155)56280400 ext 832 | ogar@servidor.unam.mx |
| 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 | |
| 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 May 23, 2013