A Pilot Study of Nanochip Technology for Monitoring Treatment Response and Detection of Relapse in Patients With Diffuse Large B-Cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Treatment response
研究概览
简要总结
This trial studies how well nanochip technology (immuno-tethered lipoplex nanoparticle [ILN] biochip) works in monitoring treatment response and in detecting relapse in participants with diffuse large B-cell lymphoma. Finding genetic markers for diffuse large B-cell lymphoma may help identify participants with this disease and help predict the outcome of treatment. It is not yet known how well ILN biochip-based testing monitors treatment response or detects relapse in participants with diffuse large B-cell lymphoma.
详细描述
PRIMARY OBJECTIVES:
I. Determine whether ILN biochip can be used to detect molecular marker(s) to monitor treatment response in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL).
II. Determine whether ILN biochip can promote early detection of disease relapse in patients with DLBCL.
OUTLINE:
Participants' blood samples undergo ILN biochip testing at diagnosis, before and after every course of chemotherapy, every 3 months for 2 years, and at relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed treatment naive DLBCL. Subtypes including high grade B-cell lymphoma, not otherwise specified (NOS) and de-novo DLBCL including germinal center B-cell type (GCB) and non-GCB subtypes.
- •Intent to receive entire care (treatment and follow-up) at Ohio State University (OSU).
- •Receiving treatment with curative intent.
- •Receiving planned 6 cycles of chemotherapy.
- •Ability to consent.
排除标准
- •Transformed lymphomas.
- •DLBCL with leukemic presentation.
- •Primary central nervous system (CNS) lymphoma.
- •Participating in other clinical trial/ receiving experimental therapy.
- •Patients with a "currently active" second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, or confound data interpretation.
- •Pregnancy (positive serum or urine pregnancy test) or breast feeding.
研究组 & 干预措施
Diagnostic (ILN biochip testing)
Participants' blood samples undergo ILN biochip testing at diagnosis, before and after every course of chemotherapy, every 3 months for 2 years, and at relapse.
干预措施: Molecular Nanotechnology (Procedure)
结局指标
主要结局
Treatment response
时间窗: Up to 2 years
The association of the expression measured by immuno-tethered lipoplex nanoparticle (ILN) biochip and quantitative reverse transcription polymerase chain reaction (qRT-PCR) will be displayed by scatter plot. Receiver operating characteristic (ROC) curves and corresponding area under the curves (AUCs) will be calculated and compared. With these data collected serially over time, patterns will be explored graphically using trace plots showing the trend across treatment for each individual participant.
Early detection of relapse
时间窗: Up to 2 years
Changes in expression between baseline and relapse will be summarized with descriptive statistics and explored graphically.
次要结局
未报告次要终点
研究者
Beth Christian
Principal Investigator
Ohio State University Comprehensive Cancer Center