Validation of Molecular Diagnostic Thecnologies for Lung Cancer Patients.

NCT03220230

Last updated date
Study Location
Centro Regional Integrado de Oncologia
Fortaleza, Caera, 60336-550, Brazil
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Lung Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Prior chemotherapy treatment.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Lung NeoplasmsA Phase 2, Randomized, Open-Label Study Of Single Agent CI-1033 In Patients With Advanced Non-Small Cell Lung Cancer
NCT00050830
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Greenbrae, California
  5. San Fransisco, California
  6. San Mateo, California
  7. San Pablo, California
  8. Tampa, Florida
  9. Chicago, Illinois
  10. Chicago, Illinois
  11. Park Ridge, Illinois
  12. Skokie, Illinois
  13. Jefferson, Indiana
  14. Crestview Hills, Kentucky
  15. LaGrange, Kentucky
  16. Louisville, Kentucky
  17. Louisville, Kentucky
  18. Louisville, Kentucky
  19. Boston, Massachusetts
  20. Boston, Massachusetts
  21. Ann Arbor, Michigan
  22. Ann Arbor, Michigan
  23. New York, New York
  24. Durham, North Carolina
  25. Cincinnati, Ohio
  26. Cincinnati, Ohio
  27. Cincinnati, Ohio
  28. Columbus, Ohio
  29. Philadelphia, Pennsylvania
  30. Nashville, Tennessee
  31. Nashville, Tennessee
  32. Houston, Texas
  33. Salt Lake City, Utah
  34. Chippewa Falls, Wisconsin
  35. Eau Claire, Wisconsin
  36. Ladysmith, Wisconsin
  37. Marshfield, Wisconsin
  38. Marshfield, Wisconsin
  39. Minocqua, Wisconsin
  40. Rice Lake, Wisconsin
  41. Stevens Point, Wisconsin
  42. Wausau, Wisconsin
  43. Wisconsin Rapids, Wisconsin
  44. Woodruff, Wisconsin
  45. Edmonton, Alberta
  46. Montreal, Quebec
  47. Gauting,
  48. Grosshansdorf,
  49. Heidelberg,
  50. Cork,
  51. Dublin,
  52. Bologna,
  53. Orbassano (Torino),
  54. Amsterdam, NH
  55. Hospitalet de Llobregat, Barcelona
  56. Glasgow,
  57. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Lung NeoplasmsA Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With Chemotherapy
NCT00074854
  1. Greenbrae, California
  2. San Mateo, California
  3. San Pablo, California
  4. Tampa, Florida
  5. Covington, Louisiana
  6. Metairie, Louisiana
  7. Metairie, Louisiana
  8. New Orleans, Louisiana
  9. Boston, Massachusetts
  10. Stony Brook, New York
  11. Philadelphia, Pennsylvania
  12. Gallatin, Tennessee
  13. Hermitage, Tennessee
  14. Lebanon, Tennessee
  15. Murfreesboro, Tennessee
  16. Nashville, Tennessee
  17. Nashville, Tennessee
  18. Nashville, Tennessee
  19. Nashville, Tennessee
  20. Smyrna, Tennessee
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Lung NeoplasmsA Phase 2, Open-Label, Multicenter Study of the GARFT Inhibitor in Patients With Metastatic Non-Small Cell Lung Cancer
NCT00090701
  1. Poway, California
  2. Washington, District of Columbia
  3. Tampa, Florida
  4. New York, New York
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Lung NeoplasmsValidation of Molecular Diagnostic Thecnologies for Lung Cancer Patients.
NCT03220230
  1. Fortaleza, Caera
  2. Aparecida De Goiana, Goias
  3. Belo Horizonte /MG, MG
  4. Belo Horizonte, MG
  5. Londrina, Parana
  6. Sao Paulo, VILA Clementino
  7. Barretos,
  8. Curtiba-PR,
  9. Porto Alegre,
  10. Porto Alegre,
  11. Recife,
  12. Rio de Janeiro,
  13. Salvador,
  14. Salvador,
  15. Salvador,
  16. Sao Paulo,
  17. Sao Paulo,
  18. São Paulo/SP,
  19. São Paulo,
  20. Temuco, Ranco
  21. Puerto Montt, Region DE LOS Lagos
  22. Valdivia, Region DE LOS Lagos
  23. Santiago, RM
  24. Independencia, Santiago, RM
  25. Arica,
  26. Concepcion,
  27. Coquimbo,
  28. Santiago,
  29. Arequipa,
  30. El Agustino,
  31. Lima,
  32. Lima,
  33. Lima,
  34. Lima,
  35. Lima,
  36. Lima,
  37. Trujillo,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Validation of Molecular Diagnostic Thecnologies for Lung Cancer Patients.
Official Title NON INTERVENTIONAL MULTICENTER STUDY, FOR THE VALIDATION OF MOLECULAR DIAGNOSTIC TECHNOLOGIES IN SUBJECTS WITH NON SMALL CELL LUNG CANCER (NSCLC) PROTOCOL N° X9001083
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.

Detailed Description

B. Lung Cancer Non-small cell lung cancer (NSCLC) is a common cause of cancer mortality throughout the world. In 2007, there were 1.5 million new lung cancer cases diagnosed worldwide, including around 733,100 cases in the South American Region.6

Approximately 85% of lung cancer is histologically defined as non small cell and the remaining 14% as small cell. The majority of patients with NSCLC present with inoperable locally advanced (Stage IIIB) or metastatic (Stage IV) disease for which no curative treatment is yet available. In newly diagnosed patients with good performance status, platinum based doublet-combination chemotherapies are associated with a median overall survival (OS) of 7.4 to 9.9 months. 7, 8, 9, 10, 11, 12 Therefore, newer agents with novel mechanisms of action are still desperately needed for this serious life-threatening disease. 15,16

The rapid and efficient identification of key driver genes in non-small-cell lung cancer (NSCLC) is becoming increasingly important.17 Clinical screening efforts have revealed that the most common mutations in lung cancer specimens involve EGFR and KRAS, along with 10 other genes that show a prevalence of mutation in 5% or less of tumors. The ALK gene is rearranged in around 3%-5% of patients with NSCLC and has been the focus of intense basic and clinical research, suggesting that the frequency of the gene rearrangement is similar in Asian and Western patients.

ROS1 is a receptor tyrosine kinase of the insulin receptor family. Chromosomal rearrangements involving the ROS1 gene were originally described in glioblastomas, where ROS1 (chromosome 6q22) is fused to the FIG gene (chromosome 6q22 immediately adjacent to ROS1), 16 and have been shown to be transforming in transgenic mice.17 More recently, ROS1 fusions were identified as potential driver mutations in an NSCLC cell line (HCC78; SLC34A2-ROS1) and an NSCLC patient sample (CD74-ROS1). 18 These fusions led to constitutive kinase activity and were associated with sensitivity in vitro and in vivo to crizotinib. As of December 2013, 16 different variants have been found.16, 17, 18

The present study is designed to advance the molecular testing methodologies to identify ALK+ and ROS1+ NSCLC patients. Advanced next generation sequencing screening methodologies will be used to identify NSCLC patients whose tumors contain a ROS1 gene inversion or translocation or an ALK translocation.

A parallel test for ALK+ by either the Abbott ALK FISH test or the Ventana ALK IHC test is necessary to validate the NGS test in all samples. A parallel test for ROS1+ by either the Kreatech FISH test or the D4D6 ROS1 IHC test may be necessary to validate the NGS test in all samples.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
tumor tissue whole blood
Sampling Method Non-Probability Sample
Study Population Lung cancer patients.
Condition Lung Neoplasms
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 20, 2019)
4240
Original Estimated Enrollment
 (submitted: July 14, 2017)
6000
Actual Study Completion Date October 30, 2018
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Prior chemotherapy treatment.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil,   Chile,   Peru
Removed Location Countries  
 
Administrative Information
NCT Number NCT03220230
Other Study ID Numbers X9001083
NIRVANA ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
Study Chair:Ricardo Armisen, MD, PhDCEMP Pfizer Chile
PRS Account Pfizer
Verification Date October 2019