The Theranostic Value of STARD3 in Colorectal Cancer: The STAR Study: a Monocentric Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Frequency of overexpression of STARD3 in both early and advanced CRC patients
研究概览
简要总结
This study aims at verifying the overexpression of STARD3 in both early and advanced CRC patients derived tissues, to identify the pathways underpinning tumorigenesis and cancer progression in which STARD3 is involved. Moreover its role as a dynamic biomarker of treatment response and its part in treatment sensitivity will be explored.
详细描述
Colorectal cancer (CRC) is one of the most prevalent and deadly tumours in both men and women worldwide. An RNAi screening on 214 potential oncogenes described by the TCGA was performed and STARD3 was identified as potential theranostic target in mCRC. Considering the effects on cell viability and the druggability, STARD3 represents a strong candidate as a valid diagnostic and therapeutic target for mCRC patients.
In recent years, organoids have become a research hotspot, showing a significant potential in the biological analysis of tumours. Patient derived organoids could be a viable platform to test clinically available drugs and/or promising new molecules to explore tumour sensitivity in an ex-vivo model.
This is a longitudinal observational study on CRC patients derived tissues to verify the overexpression of STARD3 in both early and advanced CRC patients, to identify the pathways underpinning tumorigenesis and cancer progression in which STARD3 is involved through the development of cancer derived organoids, to explore its role as a dynamic biomarker of treatment response and to demonstrate its part in treatment sensitivity measured in tumour derived organoids compared to drug sensitivity observed in real-world patients.
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
- •Histologically confirmed diagnosis of colorectal cancer, independently from diagnosis stage.
- •Age ≥18 years.
- •Signed informed consent form.
- •Availability of tissue and blood samples stored at the Institutional Biobank for research purposes.
排除标准
- •Patients for which the tumour biobanking process could compromise the diagnostic assessments.
- •Pregnancy or breast-feeding.
- •History of concomitant or previous malignancy in the previous 5 years, except for adequately treated cutaneous squamous cell carcinoma or surgically removed in situ cervical carcinoma.
结局指标
主要结局
Frequency of overexpression of STARD3 in both early and advanced CRC patients
时间窗: at enrolment
Frequency of STARD3 overexpression in both early and advanced CRC patients
次要结局
- Relation between presence of STARD3 overexpression and Overall survival (OS(from enrolment to at least 5 years)
- Difference in the mean variation of STARD3 level in patients receiving oncologic treatment, evaluated from start of treatment to the first revaluation and to disease progression(from enrolment to at least 5 years)
- Presence of STARD3 overexpression as a prognostic factor(from enrolment to at least 5 years)
- Relation between presence of STARD3 overexpression and progression-free survival (PFS)(from enrolment to at least 5 years)
- Concordance between the presence of selected molecular alterations on primary tumour tissues and organoids(up to 5 years)
- relation between variation of STARD3 overexpression and progression-free survival (PFS)(from enrolment to at least 5 years)
- Demonstrate treatment sensitivity measured in tumour derived organoids(up to 5 years)
- Relation between treatment sensitivity measured in tumour derived organoids and treatment sensitivity in patients(up to 5 years)
- Frequencies of overexpression or downregulation of selected genes alteration related to STARD3 overexpression(up to 5 years)
- Variation of STARD3 as a prognostic factor(from enrolment to at least 5 years)
- Relation between variation of STARD3 overexpression and Overall survival (OS)(from enrolment to at least 5 years)