The Added Value of Tissue or Liquid Biopsy NGS Profiling in Advanced Solid Tumor Treatment Decisions: The Belgian PRECISION Study of the BSMO in Collaboration With the Cancer Center of Sciensano.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 550
- 试验地点
- 14
- 主要终点
- Distribution of ESCAT Actionability Levels Identified by Comprehensive Genomic Profiling
研究概览
简要总结
A total of 550 patients with metastatic solid tumors or primary CNS malignancy will be recruited on a first come first serve basis at one of the 14 participating centers : UZL, UZG, Imelda, ZAZ, AZ Klina, CHU Liège, GHdC, CHU UCL Namur, IJB, UZB, CUSL, UZA, VITAZ and Jessa Zh..
> 500 patients with tissue available will undergo CGP centrally at UZ Leuven (Roche AVENIO Tumor Tissue CGP kits, Novaseq platform).
> 50 patients without tissue available will undergo liquid biopsy testing at Foundation Medicine (FoundationOne Liquid CDx).
The sequencing data generated by UZ Leuven laboratory will then be further analysed (secondary and tertiary analysis) by one of the eight laboratories participating in the study: UZL, UZG, IJB, CUSL, IPG, UZA, Jessa zh. and CHU Liège.
详细描述
GeNeo 2.0 Study PRIMARY OBJECTIVE AND ENDPOINTS
To describe the genomic landscape of advanced solid tumors and primary CNS cancer as evaluated by CGP of tumor or ctDNA (for all included patients and tumor types separate). To do so, following calculations will be performed :
- Prevalence of ESCAT level 1, 2, 3 or 4 alterations based on MTB discussion of Roche AVENIO Tumor Tissue CGP kit results.
- Prevalence of ESCAT level 1, 2, 3 or 4 alterations based on MTB discussion of Foundation One Liquid CDx results.
- Prevalence of genomic alterations according to altered gene, type of variant of tumor type.
GeNeo 2.0 Study SECONDARY OBJECTIVES AND ENDPOINTS
- To describe the number of patients receiving a treatment recommendation by the MTB.
- To describe the uptake of the MTB recommendations.
- To evaluate the treatment recommendations proposed by the MTB.
- To evaluate the reasons for discordance between the actual treatment and MTB recommendation.
- To evaluate the turnaround time of tumor CGP and ctDNA testing.
- To evaluate the technical success rate of tumor CGP and ctDNA testing.
- To evaluate the impact of CGP on patient referral and trial inclusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Adult patient (minimum 18 years) able to provide written informed consent for GeNeo 2.
- •ECOG Performance status ≤2
- •Patients with advanced solid tumors or primary CNS tumors that are candidates for systemic anticancer therapy and open for enrollment in a potential downstream therapeutic trial. Enrollment in early treatment lines is strongly encouraged Tumor cohorts of breast cancer and lung cancer will be prioritized, with a minimum cap of 100 for each tumor type. Recruitment for all other tumor type cohorts will be capped at a maximum of 40 patients per tumor type. The MTB can decide on prematurely closing or extending tumor type cohorts based on treatment recommendations, clinical trial landscape or downstream treatment options. Enrollment of patients early in the advanced treatment setting will be strongly encouraged.
- •Patients should have archived tissue available from a metastatic (preferred) or primary lesion biopsy for comprehensive profiling. The tissue should not be more than 2 years-old and fixed in 10% neutral buffered formalin. Tumor cell content should be >20%
排除标准
- •Life expectancy of ≤12 weeks according to the local investigator
- •Clinically significant hematopoietic, renal and/or hepatic dysfunction, according to the local investigator, which would make them ineligible for MGTO therapy
- •Patients unwilling to comply with GeNeo 2.0 protocol data collection, data sharing and other study procedures
- •Patients unwilling to provide informed consent and comply with study procedures.
结局指标
主要结局
Distribution of ESCAT Actionability Levels Identified by Comprehensive Genomic Profiling
时间窗: Through study completion, an average of 1 year.
Participants with at least one molecular tumor board recommendation were classified according to the highest ESCAT level identified following comprehensive genomic profiling. ESCAT Level I represents alterations with established clinical utility whereas Levels II-IV represent progressively lower levels of clinical evidence. The reported results will count the number of participants for each ESCAT level group.
Distribution of Genomic Alteration Types Identified by Comprehensive Genomic Profiling
时间窗: Through study completion, an average of 1 year.
The reported values represent the prevalence of genomic alterations according to altered gene, type of variant of tumor type.
次要结局
- Number of patients receiving a treatment recommendation(Through study completion, an average of 1 year.)
- % of uptake of the MTB recommendations(Through study completion, an average of 1 year.)
- Treatment recommendations quality.(Through study completion, an average of 1 year.)
- Participants whose treatment differed from the Molecular Tumor Board recommendation(Through study completion, an average of 1 year.)
- Participants with turnaround time within 28 days(Through study completion, an average of 1 year.)