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

NCT06136949 | Recruiting

• 1 other identifier: CRO-2023-14
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

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

  at enrolment

Secondary Outcomes (11)

• Frequencies of overexpression or downregulation of selected genes alteration related to STARD3 overexpression

  up to 5 years

• Presence of STARD3 overexpression as a prognostic factor

  from enrolment to at least 5 years

• Variation of STARD3 as a prognostic factor

  from enrolment to at least 5 years

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

  from enrolment to at least 5 years

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

  from enrolment to at least 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (1)

Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Aviano, Pordenone, 33081, Italy

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Vincenzo Canzonieri, MD,PhD

  Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincenzo Canzonieri, MD, PhD

CONTACT

0434 659 618; vcanzonieri@cro.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 18, 2023
• Study Start: May 22, 2023
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

IT (1)