Trials / Unknown
UnknownNCT02894853
Lung Cancer Early Molecular Assessment Trial
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,297 (estimated)
- Sponsor
- The Netherlands Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | Liquid (blood) biopsies and tumor biopsy (optional) | Liquid (blood) biopsies: 40 ml (maximal 10 times per patient) Tumor biopsy (optional) |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2019-06-01
- Completion
- 2019-12-01
- First posted
- 2016-09-09
- Last updated
- 2017-09-14
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT02894853. Inclusion in this directory is not an endorsement.