Colorectal CancerSTARNCT06136949
The Theranostic Value of STARD3 in Colorectal Cancer: The STAR Study
An observational study of Colorectal Cancer, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 22 May 2023to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
Aviano, Pordenone, 33081
Vincenzo Canzonieri, MD, PhD, 0434659618, vcanzonieri@cro.it
About this study
Official title: The Theranostic Value of STARD3 in Colorectal Cancer: The STAR Study: a Monocentric Observational 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.
Read the 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.
- Conditions
- Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of overexpression of STARD3 in both early and advanced CRC patients
Frequency of STARD3 overexpression in both early and advanced CRC patients
Measured: at enrolment
Secondary outcomes (11)
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
Measured: up to 5 years
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
Measured: from enrolment to at least 5 years
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.
Measured: from enrolment to at least 5 years
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
Measured: from enrolment to at least 5 years
relation between variation of STARD3 overexpression and progression-free survival (PFS)
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
Measured: from enrolment to at least 5 years
Relation between presence of STARD3 overexpression and Overall survival (OS
relation between presence of STARD3 overexpression (dichotomic variable) and Overall survival (OS) defined as time between enrollment and death, using Kaplan Meyer method
Measured: from enrolment to at least 5 years
Relation between variation of STARD3 overexpression and Overall survival (OS)
Relation between variation of STARD3 overexpression (dichotomic variable) and Overall survival (OS) defined as time between enrollment and death, using Kaplan Meyer method
Measured: 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
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
Measured: from enrolment to at least 5 years
Demonstrate treatment sensitivity measured in tumour derived organoids
Description of IC50 value (inhibitory concentration 50) for each drug tested on tumour-derived organoids
Measured: up to 5 years
Relation between treatment sensitivity measured in tumour derived organoids and treatment sensitivity in patients
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)
Measured: up to 5 years
Concordance between the presence of selected molecular alterations on primary tumour tissues and organoids
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.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start22 May 2023
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincenzo Canzonieri, MD,PhD, Principal investigator, Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136949
- Sponsor's protocol ID
- CRO-2023-14
- Acronym
- STAR
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Theranostic Value of STARD3 in Colorectal Cancer: The STAR Study: a Monocentric Observational Study
- ClinicalTrials.gov ID
- NCT06136949
- Acronym / sponsor ID
- STAR / CRO-2023-14
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincenzo Canzonieri, MD,PhD principal investigator
Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Canzonieri, MD, PhD (0434 659 618, vcanzonieri@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of overexpression of STARD3 in both early and advanced CRC patients (time frame: at enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.