The Belgian Molecular Profiling Program of Metastatic Cancer for Clinical Decision and Treatment Assignment - Precision 1
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 10
- 主要终点
- Percentage of patients enrolled in genomics-driven clinical trials and in the PRECISION 2 clinical trial.
研究概览
简要总结
PRECISION 1 will enroll patients with metastatic solid tumors. The local PI will verify if the candidate patient fits the inclusion/ exclusion criteria.
The participant will sign the PRECISION 1 informed consent. NGS data will be collected from local panel testing on DNA extracted from tissue samples or plasma.
Data will be collected from further molecular testing performed at the different laboratories: select rearrangements (fusion genes and translocations) by RT PCR, FISH or NGS; copy number variations of selected genes via the NGS platform (if possible) or using FISH or other technologies such as SNP arrays in case the NGS technology is incapable of giving this information.
Results will be stored in the Precision Belgium section of the Healthdata database.
Data on germline variants will also be collected in the Healthdata database whenever this information is available.
The cooperating clinical investigator will decide with the patient the treatment strategy, -guided by the best interest of the patient and the availability of respective options :
- " Empirical " available approved treatment (for example chemotherapy, immunotherapy)
- Genotype-driven standard of care
- Inclusion in a genotype-matched clinical trial (includes signing of trial-specific IC)
- Inclusion in PRECISION 2 if options 2/3 not available. Irrespective of treatment choice, the patient will be followed by the collaborating clinician and will have follow-up data collected every 6 months for determination of disease status and survival endpoints.
Clinical data will be collected and stored in the Healthdata database. Genomic data (somatic and germline whenever available) and clinical data (tumor type and stage, number of previous lines, treatment choice, response rate, PFS on chosen and previous treatments, ...) will be uploaded on the Healthdata platform and can be consulted via password-protected web access by the local PI at each participating center. European regulation protecting patient privacy will apply ("GDPR").
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with metastatic solid tumors that are candidates for systemic therapy (early lines are preferred).
- •Patient showing an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤
- •Patients able to provide written informed consent prior to enrollment into a subsequent clinical trial.
- •Patients agrees to provide NGS data (somatic and/or germline) as well as clinical data baseline and during follow-up.
排除标准
- •Life expectancy of less than 12 weeks.
- •Inability to comply with protocol procedures.
- •Known presence of severe hematopoietic, renal, and/or hepatic dysfunction (according to the local PI).
- •Targeted gene sequencing on DNA extracted from decalcified bone biopsies is not accepted.
结局指标
主要结局
Percentage of patients enrolled in genomics-driven clinical trials and in the PRECISION 2 clinical trial.
时间窗: 18 months
Clinical benefit rate as defined by survival and/or objective response rate and rate of stable disease lasting more than 6 months with genomics-driven therapy in non-approved indications
时间窗: 18 months
Percentage of patients with "actionable" driven mutations.
时间窗: 18 months
次要结局
未报告次要终点