N/A
N=4,240
Validation of Molecular Diagnostic Thecnologies for Lung Cancer Patients.
Lung Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT03220230 ↗Enrolled (actual)
4,240
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Number of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Biomarker — 45; 1346; 21; 38 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Biomarker |
45; 1346; 21; 38 | — |
| PRIMARY Percentage of Concordance (Agreement) Between Ventana and NGS ALK Result |
95.931; 54.217; 98.464; 68.182; 97.254 | — |
| SECONDARY Number of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Biomarker by Type of Participants |
49; 34 | — |
| SECONDARY Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking (Tobacco Use) History |
9; 32; 31; 11 | — |
| SECONDARY Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Stage and Classification of Biopsy |
2; 3; 1; 1; 7; 7 | — |
| SECONDARY Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Location |
56; 11; 9; 7 | — |
| SECONDARY Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender and Age |
28; 55; 1; 7; 37; 38 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03220230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.