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Analysis of MicroRNA Expression and Microbiome Composition During the Diagnostic-Therapeutic Pathway of Patients With Colorectal Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This multicenter prospective interventional study will evaluate stool and saliva microRNA expression and microbiome composition in patients with histologically confirmed colon or rectal cancer during key phases of the diagnostic and therapeutic pathway. The study aims to confirm and refine molecular signatures associated with colorectal cancer, assess the diagnostic and prognostic potential of salivary biomarkers, and characterize dynamic molecular changes during treatment and follow-up

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Histologically confirmed colon or rectal cancer on endoscopic biopsy

• Any T stage, any N stage, M0-M1, candidate for surgical intervention

• Colon tumors with indication for surgical resection with curative intent, including right hemicolectomy, left hemicolectomy, transverse colon resection, colectomy, or total proctocolectomy

• Rectal tumors with indication for upfront surgery or neoadjuvant chemoradiotherapy

• Written informed consent signed before any study procedure

• Age between 18 and 75 years

Locations
Other Locations
Italy
Unit of Surgical Oncology - Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
RECRUITING
Candiolo
Contact Information
Primary
Felice Borghi, MD
felice.borghi@ircc.it
0119933580
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 2500
Treatments
Experimental: Prospective Biomarker Collection Cohort
Participants with histologically confirmed colon or rectal cancer will undergo protocol-defined longitudinal collection of stool and saliva samples during the diagnostic and therapeutic pathway. At the sponsor center, FFPE tissue and blood/plasma samples may also be collected. Clinical data and diet/lifestyle questionnaire data will be prospectively recorded
Related Therapeutic Areas
Sponsors
Leads: Fondazione del Piemonte per l'Oncologia

This content was sourced from clinicaltrials.gov