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NCT Number: NCT06136949

The Theranostic Value of STARD3 in Colorectal Cancer: The STAR Study

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Aviano, Pordenone, 33081, Italy

Location status: Recruiting

Location contact

Vincenzo Canzonieri, MD, PhD

CONTACT

[email protected]

0434659618

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Frequency of overexpression of STARD3 in both early and advanced CRC patients

    Time frame: at enrolment

    Frequency of STARD3 overexpression in both early and advanced CRC patients

Secondary outcomes

  1. Frequencies of overexpression or downregulation of selected genes alteration related to STARD3 overexpression

    Time frame: up to 5 years

    Frequencies of overexpression or downregulation of selected genes alteration related to STARD3 overexpression. This analysis will be carried out in organoids cancer model

  2. Presence of STARD3 overexpression as a prognostic factor

    Time frame: from enrolment to at least 5 years

    relation between presence of STARD3 overexpression (dichotomic variable) and disease-free survival (DFS) defined as time between enrollment and objective tumor progression using Kaplan Meyer method

  3. Variation of STARD3 as a prognostic factor

    Time frame: from enrolment to at least 5 years

    STARD3 expression could change over the time and affect disease-free survival (DFS). Relation between variation of STARD3 overexpression (dichotomic variable) and DFS (defined as time between enrollment and objective tumor progression) will be accessed with Kaplan Meyer method.

  4. Relation between presence of STARD3 overexpression and progression-free survival (PFS)

    Time frame: from enrolment to at least 5 years

    relation between presence of STARD3 overexpression (dichotomic variable) and progression-free survival (PFS) defined as time between enrollment and objective tumor progression or death whichever comes first, using Kaplan Meyer method

  5. relation between variation of STARD3 overexpression and progression-free survival (PFS)

    Time frame: from enrolment to at least 5 years

    relation between variation of STARD3 overexpression (dichotomic variable) and progression-free survival (PFS) defined as time between enrollment and objective tumor progression or death whichever comes first, using Kaplan Meyer method

  6. Relation between presence of STARD3 overexpression and Overall survival (OS

    Time frame: from enrolment to at least 5 years

    relation between presence of STARD3 overexpression (dichotomic variable) and Overall survival (OS) defined as time between enrollment and death, using Kaplan Meyer method

  7. Relation between variation of STARD3 overexpression and Overall survival (OS)

    Time frame: from enrolment to at least 5 years

    Relation between variation of STARD3 overexpression (dichotomic variable) and Overall survival (OS) defined as time between enrollment and death, using Kaplan Meyer method

  8. 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

    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

  9. Demonstrate treatment sensitivity measured in tumour derived organoids

    Time frame: up to 5 years

    Description of IC50 value (inhibitory concentration 50) for each drug tested on tumour-derived organoids

  10. Relation between treatment sensitivity measured in tumour derived organoids and treatment sensitivity in patients

    Time frame: up to 5 years

    Relation between IC50 (inhibitory concentration 50) calculated for each drug tested on patients' tumour-derived organoids and PFS of patients defined as time between enrollment and objective tumor progression or death whichever comes first. Relation will be measured with Hazard Ratio (HR)

  11. Concordance between the presence of selected molecular alterations on primary tumour tissues and organoids

    Time frame: up to 5 years

    Concordance between the presence of selected molecular alterations on primary tumour tissues and organoids, frequencies will be reported and Cohen's Kappa will be calculated.

Study contacts

Contact information is provided by the study sponsor or research team.

Vincenzo Canzonieri, MD, PhD

CONTACT

[email protected]

0434 659 618

Sponsors and collaborators

Lead sponsor

Centro di Riferimento Oncologico - Aviano

Other

Registry information

Official study title

The Theranostic Value of STARD3 in Colorectal Cancer: The STAR Study: a Monocentric Observational Study

Acronym: STAR

Important dates

Study start
2023
Primary completion
2032
Study completion
2032
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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