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Trial Title:
Molecular Landscape Analysis and Clinical Implications for NSCLC Patients With Rare Mutations
NCT ID:
NCT05701787
Condition:
NSCLC
NSCLC Stage IV
NSCLC, Recurrent
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
NSCLC
rare mutations
molecular landscape
next-generation sequencing (NGS)
targeted therapy
immunotherapy
chemotherapy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
Lung cancer is the most common primary cancer of the lung and is responsible for the ever
increasing number of cancer-related deaths worldwide. Especially in China, the burden of
lung cancer has been rising rapidly due to its large and growing population.
Histologically, approximately 85% of lung cancers are non-small-cell lung cancer (NSCLC).
Molecular targeted therapy has been shown to dramatically improve the quality of life and
survival outcomes of NSCLC patients. One of the most important targeted drugs in NSCLC
has been the epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs),
while there exists some other rare targetable mutation in NSCLC. Emerging evidence
underlines that, rather than a single point mutation, some rare mutations present with a
wide array of mutations, essentially in NSCLC.
Different rare mutations with NSCLC have divergent clinical and therapeutic implications
with a particular distinction. Therefore, there is an unmet need for more effective
therapies for NSCLC with rare mutations. In summary, identification of genetic
alterations in NSCLC with rare mutations is increasingly essential to perform molecular
diagnostics and individualized treatments. This project aims to create a registry of
patients with NSCLC with rare mutations to further the characterization of molecular
alterations and develop (novel) treatments based on the detection.
Criteria for eligibility:
Study pop:
Participants with NSCLC with rare mutations are with the standard treatment and/or are
enrolled in the clinical trials.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Histologically proven diagnosis of NSCLC with rare mutations including EGFR rare
mutations, ALK fusion, ROS1 fusion, BRAF V600E, cMET exon 14 skipping, KRAS G12C,
RET fusion, NTRK fusion, etc.
- 18 years of age or older
- Ability to understand and the willingness to sign a written informed consent
document
Exclusion Criteria:
- None
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Xiaomin Niu
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaomin Niu
Phone:
021-22200000
Email:
ar_tey@hotmail.com
Facility:
Name:
Xiaomin Niu
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaomin Niu
Phone:
86 21 2220 0000
Phone ext:
3708
Email:
ar_tey@hotmail.com
Start date:
January 1, 2019
Completion date:
December 31, 2029
Lead sponsor:
Agency:
Shanghai Chest Hospital
Agency class:
Other
Source:
Shanghai Chest Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05701787
