The Theranostic Value of STARD3 in Colorectal Cancer: The STAR Study
ConditionColorectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentro di Riferimento Oncologico - Aviano
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Frequency of overexpression of STARD3 in both early and advanced CRC patients
Frequency of STARD3 overexpression in both early and advanced CRC patients
Time frame
at enrolmentSecondary outcomes
1
Frequencies of overexpression or downregulation of selected genes alteration related to STARD3 overexpression
Frequencies of overexpression or downregulation of selected genes alteration related to STARD3 overexpression. This analysis will be carried out in organoids cancer model
Time frame
up to 5 years2
Presence of STARD3 overexpression as a prognostic factor
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
Time frame
from enrolment to at least 5 years3
Variation of STARD3 as a prognostic factor
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.
Time frame
from enrolment to at least 5 years4
Relation between presence of STARD3 overexpression and progression-free survival (PFS)
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
Time frame
from enrolment to at least 5 yearsSponsors and contacts
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Source ClinicalTrials.gov