The Theranostic Value of STARD3 in Colorectal Cancer: The STAR Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Theranostic Value of STARD3 in Colorectal Cancer: The STAR Study: a Monocentric Observational Study
Overview
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.
Detailed description
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.
Primary outcome measures
- Frequency of overexpression of STARD3 in both early and advanced CRC patients [Time frame: at enrolment]
Secondary outcome measures (11)
- Frequencies of overexpression or downregulation of selected genes alteration related to STARD3 overexpression [Time frame: up to 5 years]
- Presence of STARD3 overexpression as a prognostic factor [Time frame: from enrolment to at least 5 years]
- Variation of STARD3 as a prognostic factor [Time frame: from enrolment to at least 5 years]
- Relation between presence of STARD3 overexpression and progression-free survival (PFS) [Time frame: from enrolment to at least 5 years]
- relation between variation of STARD3 overexpression and progression-free survival (PFS) [Time frame: from enrolment to at least 5 years]
- Relation between presence of STARD3 overexpression and Overall survival (OS [Time frame: from enrolment to at least 5 years]
- Relation between variation of STARD3 overexpression and Overall survival (OS) [Time frame: 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 [Time frame: from enrolment to at least 5 years]
- Demonstrate treatment sensitivity measured in tumour derived organoids [Time frame: up to 5 years]
- Relation between treatment sensitivity measured in tumour derived organoids and treatment sensitivity in patients [Time frame: up to 5 years]
- Concordance between the presence of selected molecular alterations on primary tumour tissues and organoids [Time frame: up to 5 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS — Aviano
Identifiers
NCT: NCT06136949 · CRO-2023-14