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NCT03833934 · ClinicalTrials.gov registry record
Study of Plasma NGS for Assessment, Characterization, Evaluation of Patients With ALK Resistance
A clinical trial, sponsored by Addario Lung Cancer Medical Institute.
- Completed
- Registry status
- 62
- Enrollment target
NCT03833934: Completed study, sponsored by Addario Lung Cancer Medical Institute.
NCT03833934 is a clinical trial that has completed, run by Addario Lung Cancer Medical Institute. The registered enrollment target is 62 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03833934 has completed, sponsored by Addario Lung Cancer Medical Institute.
- COMPLETED
- Registry status
- 62 participants
- Enrollment target
Study Summary
ALK-positive lung cancer is a subtype of lung cancer which carries a change in a gene called ALK (anaplastic lymphoma kinase). There are now many drugs for patients with ALK-positive lung cancer that slow cancer growth. However, after some time, just as bacteria evolve resistance to antibiotics, ALK-positive lung cancers evolve ways to avoid the therapies by developing new mutations so the drugs lost their effectiveness. These new mutations can potentially be treated with a different drug. For these new therapies, the range of mutations that can develop at resistance is not well understood. It is now possible to detect the presence of mutations or changes in the genetic structure in lung cancer by analyzing a patient's blood for bits of material shed by tumor. This approach is often called a liquid biopsy. Recently, researchers have shown that looking at tumor molecules through liquid biopsies can provide doctors with some of the same information that tissue biopsies provide. For example, liquid biopsies can be used to detect mutations that cause drug resistance. Obtaining liquid biopsies on patients with ALK-positive lung cancers at resistance to therapy may help better understand the different mutations that develop and guide therapy decisions. In this research study, a blood specimen will be collected and submitted for liquid biopsy analysis at a commercial diagnostic company. This company specializes in analyzing tumor material found in blood. Specifically, it will look for genetic changes in the ALK gene that could help understand why a cancer has developed drug resistance. This research study is for lung cancer patients with ALK-positive lung cancer who had been on a newer ALK targeted treatment (such as ceritinib, alectinib, brigatinib, or lorlatinib) to determine whether they have developed ALK resistance mutations. The investigators will collect a blood sample to examine these mutations. Participants will not have to have a tissue biopsy to participate i
Primary Outcome
To determine the prevalence of the ALK gene fusion in the cohort of patients with ALK-positive NSCLC with progression
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2019-01-23 |
| Est. Completion | 2023-10-31 |
What the finished NCT03833934 record still lists
NCT03833934 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 62 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03833934 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03833934 about?
NCT03833934 is a clinical study titled "Study of Plasma NGS for Assessment, Characterization, Evaluation of Patients With ALK Resistance". ALK-positive lung cancer is a subtype of lung cancer which carries a change in a gene called ALK (anaplastic lymphoma kinase). There are now many drugs for patients with ALK-positive lung cancer that slow cancer growth. However, after some time, just as bacteria evolve resistance to antibiotics, ALK...
What is the current status of trial NCT03833934?
This trial is currently completed. The enrollment target is 62 participants. The study started on 2019-01-23. Estimated completion is 2023-10-31.
Who is sponsoring clinical trial NCT03833934?
This trial is sponsored by Addario Lung Cancer Medical Institute, which has 8 total clinical trials registered on ClinicalTrials.gov.
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