Therapeutic and Prognostic Impact of Circulating Tumor Ce... | NCT01052818

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

NCT01052818

Sponsor

National Institute of Cancerología

Status

Unknown status

Last Update Posted

Jan 20, 2010Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Circulating Tumor Cells

Interventions

Not provided

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
87453	Other Identifier	National Counsil of Science and Technology

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Aug 2008Estimated

Completion Date

Not provided

First Submitted Date

Jan 18, 2010

First Submission Date that Met QC Criteria

Jan 18, 2010

First Posted Date

Jan 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2010

Last Update Posted Date

Jan 20, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stage IV NSCLC		Stage IV non small-cell lung cancer patients will be recruited for this protocol

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response rate, progression-free survival and over-all survival		4 years

Secondary Outcomes

Measure	Description	Time Frame
Quantification of CTCs		4 years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Advanced non small-cell lung cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Oscar Arrieta, MD	Contact	(0155)56280400	832	ogar@servidor.unam.mx

Overall Officials

Name	Affiliation	Role
Oscar Arrieta, MD	National Counsil of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institute of Cancerologia	Recruiting	Mexico City	Mexico City	14080	Mexico

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24934364	Derived	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.

ID	Term
D009360	Neoplastic Cells, Circulating
D002289	Carcinoma, Non-Small-Cell Lung

ID	Term
D009362	Neoplasm Metastasis
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes