Trial Outcomes & Findings for Validation of Molecular Diagnostic Thecnologies for Lung Cancer Patients. (NCT NCT03220230)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

4240 participants

Primary outcome timeframe

40 months

Results posted on

2019-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	Non-Small Cell Lung Cancer Participants Tissue and blood samples of participants with non-small cell lung cancer (NSCLC) were collected and analyzed to validate new molecular diagnostic technologies (such as Next Generation Sequencing \[NGS\]) and to compare their performance with the available standard tests. Participants were not treated or affected and only participated in the study for the initial samples and clinical parameters collection.
Overall Study STARTED	4240
Overall Study COMPLETED	4240
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Validation of Molecular Diagnostic Thecnologies for Lung Cancer Patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-Small Cell Lung Cancer Participants n=4240 Participants Tissue and blood samples of participants with NSCLC were collected and analyzed to validate new molecular diagnostic technologies (such as NGS) and to compare their performance with the available standard tests. Participants were not treated or affected and only participated in the study for the initial samples and clinical parameters collection.
Age, Continuous	65.998 years STANDARD_DEVIATION 11.495 • n=5 Participants
Sex: Female, Male Female	2011 Participants n=5 Participants
Sex: Female, Male Male	2229 Participants n=5 Participants
Race/Ethnicity, Customized Asian	27 Participants n=5 Participants
Race/Ethnicity, Customized Black	68 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	511 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	3236 Participants n=5 Participants
Race/Ethnicity, Customized Native Indian	10 Participants n=5 Participants
Race/Ethnicity, Customized Other	388 Participants n=5 Participants

PRIMARY outcome

Timeframe: 40 months

Population: Per protocol analysis set included all participants with valid IHC-Ventana and NGS-OFA results.

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.

Outcome measures

Outcome measures
Measure	Non-Small Cell Lung Cancer Participants n=1450 Participants Tissue and blood samples of participants with NSCLC were collected and analyzed to validate new molecular diagnostic technologies (such as NGS) and to compare their performance with the available standard tests. Participants were not treated or affected and only participated in the study for the initial samples and clinical parameters collection.
Number of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Biomarker ALK-true positive	45 Participants
Number of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Biomarker ALK-true negative	1346 Participants
Number of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Biomarker ALK-false positives	21 Participants
Number of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Biomarker ALK-false negative	38 Participants

PRIMARY outcome

Timeframe: 40 months

Population: Per protocol analysis set included all participants with valid IHC-Ventana and NGS-OFA results. Here, "Number analyzed" signifies the number of participants evaluable at specific rows.

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.