An observational study in Carcinoma, Non-Small-Cell Lung, sponsored by The Netherlands Cancer Institute. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-14.
Sponsored by The Netherlands Cancer Institute · Observational
The investigators hypothesize that an early molecular profiling, that includes both tissue and blood-bases analysis, for all NSCLC patients, including stage I-III, will increase diagnostic efficiency. When molecular profiles are available at an earlier stage of disease, more patients will benefit from personalized therapy once needed. This will result in both a better quality of life and outcome.
In this prospective multicentre trial tumours of all patients presenting with NSCLC will be profiled upfront, irrespective of disease stage and pathology using both tissue and blood-based genetic testing. A minimal molecular profiling is depicted but other targets will be included in due time. The study is divided in two parts. In the first part participating centres will have a run-in period of half a year in which molecular profiling is performed as is currently standard of care. This period will be used to measure the impact of increased awareness on the diagnostic process. During the second part of the study a comprehensive upfront profiling according to local standards will take place for all NSCLC patients. Liquid (blood) biopsies will be included in order to increase the diagnostic yield for those patients where tissue biopsies are not adequate. Patients will be treated according to standard of care, or included in clinical studies where appropriate. Re-biopsies (both tissue and liquid) will be advocated at the time of establishing disease progression/disseminated disease, and personalized therapy will be initiated according to the existing data from the molecular profiling.
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's planned enrollment of 1,297 is above the median of 164 across 974 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →The Netherlands Cancer Institute is the lead sponsor of 230 studies on the registry; 66 are open to participants now.
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All patients presenting with NSCLC will be profiled upfront, irrespective of disease stage and pathology using both tissue and blood-based genetic testing
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Liquid (blood) biopsies: 40 ml (maximal 10 times per patient) Tumor biopsy (optional)
The percentage of patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis
Patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis
Time frame: 3 years
Include the test performance of both techniques in different stage of disease
Test performance of both techniques in different stage of disease
Time frame: 3 years
The percentage of patients with a predefined actionable genetic alteration
Patients with a predefined actionable genetic alteration
Time frame: 3 years
The costs
The costs
Time frame: 3 years
The influence of the liquid biopsies on the diagnostic yield of tissue molecular and pathological analysis.
Liquid biopsies on the diagnostic yield of tissue molecular
Time frame: 3 years
Plan to share: No
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →
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