Clinical trial NCT06136949: The Theranostic Value of STARD3 in Colorectal Cancer: The STAR Study
Official title: The Theranostic Value of STARD3 in Colorectal Cancer: The STAR Study: a Monocentric Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Lead sponsor: Centro di Riferimento Oncologico - Aviano
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive CRC patients with available tumour tissue biopsies (primary surgery or diagnostic endoscopy) stored in the Institutional Biobank will be enrolled. Available biopsies collected from 1st January 2012 to 31st December 2027 will be considered.

Brief summary: 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.

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.

Primary outcomes:
measure: Frequency of overexpression of STARD3 in both early and advanced CRC patients
timeFrame: at enrolment
Secondary outcomes:
measure: Frequencies of overexpression or downregulation of selected genes alteration related to STARD3 overexpression
timeFrame: up to 5 years
measure: Presence of STARD3 overexpression as a prognostic factor
timeFrame: from enrolment to at least 5 years
measure: Variation of STARD3 as a prognostic factor
timeFrame: from enrolment to at least 5 years
measure: Relation between presence of STARD3 overexpression and progression-free survival (PFS)
timeFrame: from enrolment to at least 5 years
measure: relation between variation of STARD3 overexpression and progression-free survival (PFS)
timeFrame: from enrolment to at least 5 years
measure: Relation between presence of STARD3 overexpression and Overall survival (OS
timeFrame: from enrolment to at least 5 years
measure: Relation between variation of STARD3 overexpression and Overall survival (OS)
timeFrame: from enrolment to at least 5 years
measure: 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
timeFrame: from enrolment to at least 5 years
measure: Demonstrate treatment sensitivity measured in tumour derived organoids
timeFrame: up to 5 years
measure: Relation between treatment sensitivity measured in tumour derived organoids and treatment sensitivity in patients
timeFrame: up to 5 years
measure: Concordance between the presence of selected molecular alterations on primary tumour tissues and organoids
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
state: Pordenone
Study officials:
affiliation: Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
name: Vincenzo Canzonieri, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: