The Theranostic Value of STARD3 in Colorectal Cancer: The STAR Study
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- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
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- Состояния в реестре: Colorectal Cancer. Базовые параметры: от 18 лет · Все.
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- Италия
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Официальное название
The Theranostic Value of STARD3 in Colorectal Cancer: The STAR Study: a Monocentric Observational Study
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Frequency of overexpression of STARD3 in both early and advanced CRC patients [Срок оценки: at enrolment]
Вторичные конечные точки (11)
- Frequencies of overexpression or downregulation of selected genes alteration related to STARD3 overexpression [Срок оценки: up to 5 years]
- Presence of STARD3 overexpression as a prognostic factor [Срок оценки: from enrolment to at least 5 years]
- Variation of STARD3 as a prognostic factor [Срок оценки: from enrolment to at least 5 years]
- Relation between presence of STARD3 overexpression and progression-free survival (PFS) [Срок оценки: from enrolment to at least 5 years]
- relation between variation of STARD3 overexpression and progression-free survival (PFS) [Срок оценки: from enrolment to at least 5 years]
- Relation between presence of STARD3 overexpression and Overall survival (OS [Срок оценки: from enrolment to at least 5 years]
- Relation between variation of STARD3 overexpression and Overall survival (OS) [Срок оценки: 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 [Срок оценки: from enrolment to at least 5 years]
- Demonstrate treatment sensitivity measured in tumour derived organoids [Срок оценки: up to 5 years]
- Relation between treatment sensitivity measured in tumour derived organoids and treatment sensitivity in patients [Срок оценки: up to 5 years]
- Concordance between the presence of selected molecular alterations on primary tumour tissues and organoids [Срок оценки: up to 5 years]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 1 центр
- Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS — Aviano
Идентификаторы
NCT: NCT06136949 · CRO-2023-14