Validation of Molecular Diagnostic Thecnologies for Lung Cancer Patients.

NCT03220230 | Completed Results

• 2 other identifiers: X9001083NIRVANA
• Study Type: observational
• Target: 4,240
• Locations: 3 countries
• Sites: 37

Brief Summary

This is a non-interventional multi-center with investigational sites in Chile and Brasil diagnostic study to validate novel diagnostic technologies, such as Next Generation Sequencing (NGS) from both tissue and blood compared to the current gold standard. As a non-interventional study, patients will receive the treatment indicated by their doctor independently of their participation on this study. Many cancer cells look the same under the microscope. But as these cells are studied at the molecular level, some genetic alterations or defects that are more common to certain types of cancer are identified. In some cases, these defects are what make the cells grow and multiply abnormally. Biomarkers are the molecular fingerprints of these genetic defects. By testing a sample of your tumor for biomarkers, doctors can learn if your cancer has one of these defects, and that may point to a specific treatment choice. One of the genetic biomarkers that are believed to cause some cancers to grow is the ALK fusion gene. About 3% to 5% of people with NSCLC may test positive for ALK. ROS1 is a receptor found in 1 to 2% of people with this type of cancer. The present study is designed to advance the molecular testing methodologies to identify ALK+ and ROS1+ NSCLC patients. A positive correlation with these new technologies will mean an efficient, more accurate diagnostic test, which could impact a greater number of cancer patients around world.

Conditions

Lung Neoplasms

Keywords

Next generation sequencing; Lung cancer; target therapies

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Biomarker

  ALK status was measured by NGS- Oncomine focus assay (OFA) and Immuno histo chemistry (IHC) Ventana. Ventana -ALK and NGS-OFA were the assay procedures performed for ALK. The corresponding analysis of a specimen had 2 possible test results including ALK positive and ALK negative. True positives (tp) were defined as NGS-OFA and Ventana positive results, whereas false negatives (fn) were defined as NGS-OFA negative results and IHC-Ventana positive results. False positives (fp) were defined as NGS-OFA positive results and IHC-Ventana negative results. True negatives (tn) were defined as NGS-OFA and IHC Ventana negative results.

  40 months

• Percentage of Concordance (Agreement) Between Ventana and NGS ALK Result

  In this outcome measure, index of concordance with accuracy, sensitivity, specificity, positive predictive value and negative predictive value were measured. Accuracy (Acc): \[tp+tn\]/\[tp+fp+fn+tn\] \*100; Sensitivity (Ss): tp/\[tp+fn\] \*100; Specificity (Sp): tn/\[fp+tn\] \*100; Positive Predictive Value (PPV): tp/\[tp+fp\] \*100; Negative Predictive Value (NPV): tn/\[fn+tn\] \*100.

  40 months

Secondary Outcomes (5)

• Number of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Biomarker by Type of Participants

  40 months

• Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking (Tobacco Use) History

  40 months

• Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Stage and Classification of Biopsy

  40 months

• Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Location

  40 months

• Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender and Age

  40 months

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

Lung cancer patients.

You may qualify if:

• Female or male, 18 years of age or older.
• Patients with histologically or cytological proven diagnosis of NSCLC, pathologically identified as adenocarcinoma.
• Patient naïve in lung cancer treatment
• Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the study prior to enrollment.
• Patients must give consent to the research use of their archived or tumor FFPE tissue, and if available, 2 blood tubes.

You may not qualify if:

• Prior chemotherapy treatment.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (37)

Centro Regional Integrado de Oncologia

Fortaleza, Caera, 60336-550, Brazil

Location

Instituto Goiano de Oncología e Hematologia

Aparecida de Goiana, Goiás, 74915-520, Brazil

Location

Hospital Luxemburgo

Belo Horizonte, Minas Gerais, 30380-472, Brazil

Location

Hospital Felicio Rocho

Belo Horizonte /MG, Minas Gerais, 30110-934, Brazil

Location

Instituto de Cancer de Londrina

Londrina, Paraná, Brazil

Location

Centro de Pesquisa da Universidade Federal de Sao Paulo - UNIFESP

São Paulo, VILA Clementino, 04024-002, Brazil

Location

Fundaçao Pio XII, Hospital do Cancer de Barretos

Barretos, Brazil

Location

Liga Paranaense de Combate ao Cancer Hospital Erasto Gaetner

Curtiba-PR, Brazil

Location

Hospital Sao Lucas da PUCRS

Porto Alegre, Brazil

Location

Irmandade da Santa Casa de Misericordia de Porto Alegre (ISCMPA) - Hospital Santa Rita

Porto Alegre, Brazil

Location

Instituto de Medicina Integral Prof. Fernando Figueira - IMIP

Recife, Brazil

Location

Instituto COI de Pesquisa Educacao e Gestao

Rio de Janeiro, 22793-080, Brazil

Location

Hospital Da Bahia

Salvador, 41820-011, Brazil

Location

Hospital Santa Izabel

Salvador, Brazil

Location

Nucleo de Oncologia da Bahia

Salvador, Brazil

Location

Instituto de Oncologia de Sorocaba - ONCO Clinicas Especializadas SC Ltda

São Paulo, 18035-300, Brazil

Location

A.C. Camargo Cancer Center

São Paulo, Brazil

Location

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São Paulo, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo/SP, 05651-901, Brazil

Location

Hospital Base de Puerto Montt

Port Montt, Los Lagos Region, 5506667, Chile

Location

Hospital Base de Valdivia

Valdivia, Los Lagos Region, 5090145, Chile

Location

Instituto Clinico Oncologico del Sur (ICOS)

Temuco, Ranco, 4810469, Chile

Location

Centro Internacional de Estudios Clinicos

Santiago, RM, 8420383, Chile

Location

Hospital Clinico Universidad de Chile, Seccion de Oncologia

Independencia, Santiago, RM, 8380456, Chile

Location

Hospital Base de Arica

Arica, Chile

Location

Hosp Regional de Concepcion

Concepción, Chile

Location

Universidad Católica del Norte

Coquimbo, Chile

Location

Instituto Nacional Del Torax

Santiago, Chile

Location

Hospital Carlos Alberto Seguin Escobedo

Arequipa, Peru

Location

Hospital Nacional Hipolito Unanue

El Agustino, Peru

Location

Clinica San Felipe

Lima, 11, Peru

Location

Hospital Central de la Fuerza Aerea Peruana

Lima, 18, Peru

Location

Instituto Nacional de Enfermedales Neoplasicas (INEN)

Lima, 34, Peru

Location

Oncosalud

Lima, 41, Peru

Location

Unidad de Investigacion de la Clinica Internacional - Sede San Borja

Lima, 41, Peru

Location

Clínica Quirurgica Santa Maria

Lima, Peru

Location

Centro de Investigación Clínica Trujillo E.I.R.L.

Trujillo, 13001, Peru

Location

Related Links

• To obtain contact information for a study center near you, click here.

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissue whole blood

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

• Ricardo Armisen, MD, PhD

  CEMP Pfizer Chile

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 18, 2017
• Study Start: July 6, 2015
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: November 8, 2019
• Results First Posted: November 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

PE (9); CL (9); BR (19)