Molecular Characterization of Solid Tumors and Lymphomas to Optimize the Drug Development Process and Patients Enrollment in Early Phase Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Accrual rate in early phase clinical trials
研究概览
简要总结
Prospective, single centre, non-interventional exploratory research project that will be conducted on biological material and health-related personal data collected.
详细描述
Single center, two-parts pilot, prospective study to assess the role of molecular tumor profiling in supporting patient enrollment in early phase clinical trials.
Part A: patients with solid tumors or lymphomas (n=40) who are potential candidates for early phase clinical trials will be offered to have their more recent archival tumor tissue analyzed for the presence of somatic genomic alterations with the pan-cancer NGS Ion TorrentTM OncomineTM Comprehensive Assay v3 platform.
Part B: patients who have been enrolled in early phase clinical trials (estimated number: 16-18) will have their archival tumor tissue assessed with HTG EdgeSeq Oncology Biomarker Panel Assay for RNA-Seq to explore gene expression signatures and blood collected and stored to create a repository of samples (¨liquid biopsy¨) for future research with the aim to investigate the mutational profile of ctDNA at baseline and the acquisition of new mutations at the time of disease progression as a consequence of treatment exposure.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Male or female patients age at least 18 years.
- •Patients with histological diagnosis of advanced solid tumor or lymphoma who are potential candidates for early phase clinical trials.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- •Live expectancy of at least 6 months.
- •Availability of FFPE archival tumor tissue from previous surgery or diagnostic biopsy adequate for molecular analysis.
- •Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure.
- •Willing and able to comply with study procedures
排除标准
- •Presence of any clinical (e.g. concomitant disease, clinically significant symptoms, or non-clinical (psychological or social) conditions that would not make the patient eligible for enrolment in an early phase clinical trial.
- •Any other active malignancy (other than the one for which the subject is being assessed for trial option) that is progressing or requiring active treatment with the exception of basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of any site.
结局指标
主要结局
Accrual rate in early phase clinical trials
时间窗: Two years
Number of patients with available molecular profile enrolled per year
次要结局
- Clinical Outcome(Two years)
- Rate of stored samples(Two years)
- Number of successful NGS-based DNA analysis performed on archival tissue(Two years)
- Number of NGS-based RNA-seq samples analyzed(Two years)