NCT02507947撤回不适用
SPECTAmel: Screening Patients With Melanoma Tumors for Efficient Clinical Trial Access
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of screened patients
研究概览
简要总结
SPECTAmel is a standardized, quality-assured molecular screening platform for tumor characterization and storage of human biological material (HBM) for the purpose of integrating new biomarkers into clinical trials and optimizing access of patients to therapeutic biomarker-driven clinical trials. HBM and clinical/pathological data are collected from consenting patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Pathologically confirmed melanoma of any stage (the steering committee will decide on which stage to include at any particular time point during this trial, this will be communicated appropriately to all participating sites)
- •Mandatory availability of adequate human biological material (HBM): FFPE tissue sample from the primary tumor, recurrent tumor, metastasis, obtained at the time of primary surgery/biopsy; minimal amount requested is detailed in the HBM guidelines; if feasible, inclusion of samples taken at any recurrence diagnosed during follow-up is strongly encouraged but optional;
- •Age ≥ 18 years;
- •At least three months life-expectancy;
- •Written informed consent according to ICH/GCP and national/local regulations;
- •Absence of any active malignancy, except pT1-2 prostatic cancer Gleason score < 6, or carcinoma in situ of the cervix, in the 5 years before study entry;
- •Absence of exclusion criteria like active hepatitis B/C or HIV, second malignancies, no severe organ dysfunction or other comorbidities that may prevent inclusion into clinical trials.
- •Central confirmation of human biological material (HBM) adequacy for step 2:
- •Centrally performed confirmation of tumor tissue adequacy in terms of quality/ quantity for central screening.
排除标准
- •active hepatitis B/C or HIV
- •second malignancies
- •severe organ dysfunction or other comorbidities
结局指标
主要结局
Number of screened patients
时间窗: 5 years
Number of downstream clinical trials;
时间窗: 5 years
Number of patients enrolled in the downstream therapeutic trials
时间窗: 5 years
Number of exploratory/future research projects
时间窗: 5 years
次要结局
未报告次要终点
研究者
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