MIMICC Study in Patients With Colorectal Cancer

Официальное название

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

Обзор

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

Подробное описание

MIMICC is a multicenter prospective interventional academic study sponsored by Fondazione del Piemonte per l'Oncologia - IRCCS Istituto di Candiolo. Approximately 2,500 patients with histologically proven colon or rectal cancer will be enrolled. Biological samples will include stool and saliva collected at protocol-defined time points during the diagnostic and therapeutic pathway; at the sponsor center, FFPE tissue and blood/plasma samples may also be collected for additional molecular analyses. The study will investigate microbiome composition and miRNA expression profiles at diagnosis, after neoadjuvant treatment when applicable, at surgery, during postoperative follow-up, during systemic treatment, and at recurrence. Clinical, dietary, and lifestyle data will be integrated with molecular data to identify and refine biomarkers for diagnosis, prognosis, treatment response, surgical complications, and recurrence risk. Initial sample collection will be performed for approximately 4 months at the sponsor center before extension to the collaborating centers.

Вмешательства

• Другое Prospective Biological Sample Collection and Longitudinal Molecular Profiling
  Protocol-defined collection of stool and saliva samples at diagnosis/baseline, after neoadjuvant treatment when applicable, at surgery after bowel preparation, at the time of anastomotic leak when applicable, 30 days after surgery, at day 0 of chemotherapy when applicable, at the end of chemotherapy, and at recurrence. At the sponsor center, FFPE tissue and blood/plasma samples may also be collected. Molecular analyses include microbiome profiling, miRNA sequencing, and mutational profiling on F
• Другое Diet and Lifestyle Assessment
  Administration of the EPIC food frequency questionnaire and the WCRF diet/lifestyle score at diagnosis and approximately 1 year later, with integration of BMI and physical activity data.

Первичные конечные точки

• Diagnostic accuracy of fecal microbiome and fecal microRNA molecular signatures [Срок оценки: At diagnosis/baseline, before surgery or at least 30 days after bowel preparation for colonoscopy]
• Diagnostic and prognostic performance of salivary microbiome and microRNA molecular signatures [Срок оценки: From baseline sample collection through follow-up, up to 2 years]
• Longitudinal change in stool and saliva microbiome and microRNA profiles [Срок оценки: From diagnosis/baseline through recurrence or up to 2 years after enrollment]
• Integrated colorectal cancer microbiome/microRNA atlas dataset [Срок оценки: From enrollment through study completion, up to 4 years]

Вторичные конечные точки (7)

• Molecular signatures in patients receiving neoadjuvant treatment [Срок оценки: From baseline to end of neoadjuvant treatment, up to 6 months]
• Biomarker profiles in participants with microsatellite instability-high tumors [Срок оценки: From baseline through end of standard treatment and follow-up, up to 2 years]
• Effect of bowel preparation on fecal microbiome and microRNA profiles [Срок оценки: From preoperative/pre-intervention baseline to intraoperative sample collection]
• Biomarker profiles associated with early-onset colorectal cancer [Срок оценки: At diagnosis/baseline]
• Microbiome and microRNA profiles associated with anastomotic leak [Срок оценки: From surgery to first documented anastomotic leak, assessed during postoperative follow-up up to 30 days after surgery]
• Association of diet, body mass index, and physical activity with microbiome and microRNA profiles [Срок оценки: From diagnosis to approximately 1 year after diagnosis]
• Tumor mutational profile in FFPE tissue [Срок оценки: From tissue collection during routine diagnostic or surgical procedures through study completion, up to 4 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Tis/T1 lesions or lesions almost completely resected by endoscopic polypectomy/EMR/ESD
• Use of immunosuppressive or immunomodulatory drugs within the previous 6 months
• Current or previous diagnosis of other solid or hematologic malignancies
• Inability or refusal to provide informed consent
• Inability or refusal to be followed at the study institution/network

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Италия · 1 центр

• Unit of Surgical Oncology - Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Can — Candiolo

Идентификаторы

NCT: NCT07494201 · 005-FPO25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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