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IMMUNOlogical Microenvironment in REctal Adenocarcinoma Treatment.

NCT04917263 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 544

Last updated 2021-06-08

No results posted yet for this study

Summary

Background The current management on rectal cancer based on TNM staging has some limitations. In locally advanced rectal cancer after neoadjuvant therapy the persistence of a complete response to therapy cannot be accurately predicted by the simple tumor regression grade. The current guidelines recommend the complete rectal resection with a total mesorectal excision. The implications for patients' quality of life are evident even in case of sphincter sparing surgery. Moreover, in both cases the cancer sample available for the analysis can be small or inexistent. Hypothesis The main hypothesis underlying our research is that the aggressiveness of rectal cancer is determined by the complex interactions between the malignant cells and their immune microenvironment. The second hypothesis is that relevant trace of this cross talk between tumor cells and immune microenvironment can be detected in the normal mucosa surrounding the cancer according to the concept of field cancerization.

Aims The aim of this project is to analyze the healthy rectal mucosa surrounding the cancer to identify traces of immunosurveillance mechanisms and of field cancerization and to use them to obtain a composite prognostic test to predict recurrence after complete response at neoadjuvant therapy in case of locally advanced rectal cancer.

Experimental Design This prognostic test will be constructed on the combinatory analysis of the transcriptome, immune and epithelial cells cross-talk, immune checkpoints and miRNA expression in normal rectal mucosa surrounding cancer. The project aim is to identify, among locally advanced rectal cancer, those with sustained complete response to neoadjuvant chemo/radiotherapy. The study is articulated in two steps. In step A, we will retrospectively analyze archival tissue samples in order to identify the most performing biomarkers; in step B, we will validate the prognostic performance of the markers identified in phase I through a prospective analysis of rectal mucosa specimen.

Conditions

Interventions

DIAGNOSTIC_TEST

Immunohistochemistry, Flow citometry, Trascriptome analysis

we will perform immunohistochemistry, flow cytometry, transcriptomic analysis, mRNA microarray and mutational profiling

Sponsors & Collaborators

  • Associazione Italiana per la Ricerca sul Cancro

    collaborator OTHER

  • Azienda Ospedaliera di Padova

    collaborator OTHER

  • Istituto Oncologico Veneto IRCCS

    collaborator OTHER

  • Azienda ULSS 3 Serenissima

    collaborator OTHER

  • Azienda Ulss 2 Marca Trevigiana

    collaborator OTHER

  • University of Padova

    lead OTHER

Principal Investigators

  • Marco Scarpa, MD, PhD · Clinica Chirurgica I, Azienda Ospedale Università di Padova

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04917263 on ClinicalTrials.gov