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Trial Title:
The Theranostic Value of STARD3 in Colorectal Cancer: The STAR Study
NCT ID:
NCT06136949
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Vincenzo Canzonieri, MD, PhD
Phone:
0434659618
Email:
vcanzonieri@cro.it
Start date:
May 22, 2023
Completion date:
December 31, 2032
Lead sponsor:
Agency:
Centro di Riferimento Oncologico - Aviano
Agency class:
Other
Source:
Centro di Riferimento Oncologico - Aviano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06136949
