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

NCT01052818 | Unknown

• 2 other identifiers: INCAN/OfCA204/SO151/CB451/0987453
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Circulating Tumor Cells

Keywords

Non small-cell lung cancer; Circulating tumor cells; Carcinoembryonic antigen; Cytokeratin

Outcome Measures

Primary Outcomes (1)

• Response rate, progression-free survival and over-all survival

  4 years

Secondary Outcomes (1)

• Quantification of CTCs

  4 years

Study Arms (1)

Stage IV NSCLC

Stage IV non small-cell lung cancer patients will be recruited for this protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced non small-cell lung cancer

You may qualify if:

• 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

You may not qualify if:

• Non-advanced disease

Sponsors & Collaborators

• National Institute of Cancerología: lead

Study Sites (1)

National Institute of Cancerologia

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Related Publications (1)

• Arrieta O, Pineda B, Muniz-Hernandez S, Flores D, Ordonez G, Borbolla-Escoboza JR, Orta D. Molecular detection and prognostic value of epithelial markers mRNA expression in peripheral blood of advanced non-small cell lung cancer patients. Cancer Biomark. 2014;14(4):215-23. doi: 10.3233/CBM-140394.

  PMID: 24934364 DERIVED

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.

MeSH Terms

Conditions

Neoplastic Cells, Circulating; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Oscar Arrieta, MD

  National Counsil of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar Arrieta, MD

CONTACT

(0155)56280400; ogar@servidor.unam.mx

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 18, 2010
• First Posted: January 20, 2010
• Study Start: July 1, 2007
• Primary Completion: August 1, 2008
• Last Updated: January 20, 2010

Record last verified: 2010-01

Locations

ME (1)