SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,975
- 试验地点
- 255
- 主要终点
- To establish a quality assured platform to improve the understanding of tumor biology and cancer patients care
研究概览
简要总结
SPECTA is a quality assured platform for collecting clinicopathologically annotated biological material, imaging data, operative images, environmental assessment, questionnaires as well as patient-reported outcomes from cancer patients to support biospecimen-based translational research and clinical cancer research, including biomarker discovery to improve the understanding of tumor biology and cancer patients care.
详细描述
Patients are recruited in the platform for the research purpose of 5 downstream projects. For more information, please have a look at the "Groups and cohorts" section.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologically confirmed selected tumor types (at site or centrally);
- •Mandatory availability of adequate human biological material (HBM);
- •Centrally performed confirmation of HBM adequacy in terms of quality and quantity for SPECTA downstream project requirements;
- •Age ≥ 12 years;
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
- •Written informed consent according to applicable legal and ethical requirements;
排除标准
- 未提供
研究组 & 干预措施
RP-1828 IMMUcan (CLOSED for recruitment since August 2024)
The goal is to generate broad molecular and cellular profiling data of the tumour and its microenvironment from cancer patients integrated with clinical data, to understand how the immune system and tumours interact, and the impact of current therapeutic interventions.
Tumor types: Thorax, Head and Neck, Breast, Gastrointestinal, Genito Urinary
干预措施: RP-1828 IMMUcan (Genetic)
RP-1759 AYA/TYA (CLOSED for recruitment since December 2021)
The pilot study will be focusing on young adults (12 to 29 years old) with rare cancer to understand better the biology of the tumor in this specific population, and compare it to children and adults with similar disease, as well as to improve the inclusion of young adults into clinical trials.
Tumor type: CNS
干预措施: RP-1759 AYA/TYA (Genetic)
RP-1843 Arcagen (CLOSED for recruitment since November 2022)
This is a collaborative project between EORTC and EURACAN to perform molecular characterisation of rare cancers patients, using Foundation Medicine tests. The goal of this project is to get a better understanding of the genomic landscape of rare cancers and potentially help define possibilities for targeted treatments/clinical trials for this population.
Tumor types: all 10 EURACAN domains
干预措施: RP-1843 Arcagen (Genetic)
RP-1920 BioRadon
The primary objective is to assess the correlation between the molecular profiles of NSCLC patients and indoor radon concentration, measured with an alpha-particle detector (a standardized and validated way of measuring indoor radon).
Tumor type: Thorax
干预措施: RP-1920 BioRadon (Genetic)
2148 MRD
The main objective of the 2148 Minimal Residual Disease Assessment project is to assess the potential of circulating tumor DNA (ctDNA) as a surrogate marker of recurrence by studying its positive predictive value (PPV). This will help determine how accurately ctDNA can predict cancer recurrence.
Tumour types: Head and Neck, Melanoma
干预措施: 2148 MRD (Genetic)
结局指标
主要结局
To establish a quality assured platform to improve the understanding of tumor biology and cancer patients care
时间窗: 5 years
material (including imaging data) as well as patient-reported outcomes from patients with cancer diagnosis to support biospecimen-based translational research and biomarker discovery to improve the understanding of tumor biology and cancer patients care.
次要结局
- To investigate the molecular pathways related to the development of specific tumors from a biological point of view;(5 years)
- To perform biospecimen and data based high quality research aiming to better understand the biology of cancer, and/or how it is currently managed and/or how to better diagnose and treat it in the future;(5 years)
- To investigate the effect of cancer treatment on the tumor, microenvironment and patients globally;(5 years)
- To collect large series of homogeneous clinical data to analyse the disease course and treatment performed;(5 years)
- To investigate the prevalence and validate the prognostic or predictive value of novel biomarkers in cancers;(5 years)
- To perform biospecimen and data based high quality research aiming to facilitate the discovery of new test for tumor biomarkers or facilitate the establishment of validated tests for tumor biomarkers;(5 years)
- To identify patients with molecular alterations in their tumor that can be matched to biomarker-driven clinical trials, to facilitate enrollment of cancer patients in biomarker-driven clinical trials.(5 years)