NCT03042221招募中不适用
Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Systemic Therapy for Lung Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- protein expression change
研究概览
简要总结
A comparison of baseline tumor characteristics in oncogene-driven cancers to tumor characteristics after early response to Tyrosine Kinase Inhibitor (TKI) targeted treatment will allow identification of early adaptive mechanisms of cell survival. This will facilitate targeting and termination of these survival/ resistance pathways before they develop with rational combinations of therapeutic agents to improve outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Targetable Oncogene - Biopsy Cohort (includes blood draw)
- •Carry a diagnosis of locally advanced or stage IV NSCLC responsive to targeted therapies (per current NCCN guidelines)
- •Aged 18 years or older
- •Have a histologically confirmed diagnosis of NSCLC harboring an activating mutation responsive to targeted therapy (per NCCN guidelines)
- •No prior systemic therapy for locally advanced or metastatic disease.
- •Planned treatment with targeted therapy specific to the oncogene driver mutation.
- •Patients must have at least one site of measurable disease ≥ 2cm.
- •Primary disease site or site of metastatic disease must be amenable to biopsy.
- •Patients must have the ability to understand and willingness to sign an informed consent document.
- •Targetable Oncogene - Blood Draw Only Cohort
- •Carry a diagnosis of locally advanced or stage IV NSCLC responsive to targeted therapy (per NCCN guidelines)
- •Aged 18 years or older
- •Have a histologically confirmed diagnosis of NSCLC harboring an activating mutation responsive to targeted therapy (per NCCN guidelines)
- •No prior systemic therapy or radiotherapy for metastatic lung cancer (surgery alone permitted)
- •Planned treatment with targeted therapy specific to the oncogene driver mutation.
- •Declines repeat biopsy option or does not have tumor site amenable to biopsy.
- •Patients must have the ability to understand and willingness to sign an informed consent document.
- •Immunotherapy Cohort - Blood Draw Only
- •Have a histologically confirmed diagnosis of locally advanced or stage IV NSCLC without a treatable activating mutation that would be amenable to targeted therapy AND planned first line treatment with immunotherapy or chemotherapy plus immunotherapy.
- •Aged 18 years or older
- •No prior systemic therapy or radiation therapy for lung cancer (surgery alone permitted)
- •Patients must have the ability to understand and willingness to sign an informed consent document.
排除标准
- •Targetable Oncogene - Biopsy Cohort (includes blood draw)
- •Concurrent health problem which would preclude tissue biopsy (e.g. hemophilia or other bleeding predisposition).
- •Patients whose only biopsy source would involve sampling an anatomic area that carries an unacceptably high procedural risk (e.g. pericardium or kidney) as deemed by the treating physician or by a proceduralist performing the biopsy.
- •Patients whose only biopsy source involves a sample that may not be evaluable due to insufficient genomic material (such as cerebrospinal or ascitic fluid) as deemed by the treating physician. .
- •Targetable Oncogene Cohort and Immunotherapy Cohort - Blood Draw Only
- •Planned follow up on therapy outside of the University of Colorado Health System
- •Unwillingness to allow for residual clinical biopsy specimens to be utilized in this study.
结局指标
主要结局
protein expression change
时间窗: baseline and 2 weeks (+/- 1 week) for each patient.
change from baseline of protein gene expression profile at 2 weeks as measured by multiplex protein assay (proteins to be assayed include: e-cadherin, vimentin, fibronectin, CD4, CD8, CD14, CD16, CD206, PDL1, and CSF1R)
gene expression changes
时间窗: baseline and 2 weeks (+/- 1 week) for each patient.
change from baseline of tumor gene expression profile at 2 weeks. Global gene expression data will be collected using RNAseq
次要结局
- Depth of Response(Study startup through 36 months)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Identification of Predictive and Prognostic Markers for Lung Cancer With MetastasesPrimary TumorMetastasesLung CancerNCT02301858Janna Berg100
尚未招募
Unknown
Study for the identification of tumor-relevant biomarkers from visceral and subcutaneous adipose tissue of obese and non-obese patients.E66C00-C97Malignant neoplasmsObesityDRKS00034238Johanniter Krankenhaus Bonn50
进行中（未招募）
不适用
An Additional Analysis of Data From the PARADIGM Exploratory Study (NCT02394834) in Patients With Advanced/Recurrent Colorectal CancerColorectal CancerNCT05030493Takeda787
撤回
不适用
Molecular Markers in Cancers and Precancers (MOCA)Precancerous LesionHealthyCancerNCT05257707Centre Hospitalier Universitaire de Besancon300
进行中（未招募）
不适用
Novel Biomarkers in the Neoplastic Progression of Barrett's EsophagusBarrett EsophagusEsophageal NeoplasmGastroesophageal RefluxNCT00431756Johns Hopkins University600