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Cola

Secondary surgery is performed in patients with pejorative histopathologic feature(s) of the tumor.

Immunoscore Colon is an in-vitro diagnostic test, allowing the quantification of CD3 and CD8 positive cells in formalin-fixed paraffin-embedded (FFPE) tissue samples of primary colon cancer.

The test uses immunohistochemistry, digital pathology techniques and a dedicated image analysis software to determine CD3+ and CD8 + cell densities in the tumor ant in the invasive margin of the tumor.

Immunoscore Colon Test

Touria El Aamri

Yvann Frigout

Franck PAGÈS, MD

Franck Pagès, MD

The overall aim of this study is to determine whether the Immunoscore associated with histopathological features of endoscopically resected stage T1 colorectal tumors is predictive of locoregional lymph node invasion, in order to better select patients eligible for an organ preservation strategy.

The frequency of stage T1 superficial colorectal cancer (CRC) is around 15% and its incidence increases. In France, T1 superficial CCR is mostly treated with endoscopic submucosal dissection (ESD), offering potentially curative, organ-preserving treatment. The presence of pejorative histological criteria (eg. poor differentiation, budding, lymphovascular invasion), detected in about 50% of the tumors, leads to a secondary colectomy or rectal resection with postoperative complications and significant digestive, urological, and sexual functional sequelae. Strikingly, secondary surgical resection is performed in excess in 70 to 80% of the cases, given that no tumor is evidence in the colon and draining lymph nodes. Organ preservation (no secondary surgery) could be offered to a larger number of patients if biomarkers could complete the histological evaluation to better predict metastatic extension to lymph nodes.

Our team showed that the type, density, and location of immune cells in CRC strongly correlated with patients' survival at all disease stages. Our team created an "Immunoscore" (IS) assay, based on CD3+ and cytotoxic CD8+ T-cell densities determined by digital pathology in the tumor and its invasive margin. The robustness and prognostic performance of IS was validated in CRC . Sub-analysis of T1 tumors was not possible (only 31 cases) and tumor specimens did not result from endoscopic resection.

The objective of the study is to determine whether the Immunoscore associated with histopathological features of endoscopically resected stage T1 colorectal tumors is predictive of locoregional lymph node invasion, in order to better select patients eligible for an organ preservation strategy.

Personalized Medicine in Early Stage Colorectal Cancer: Organ Preservation and Immune Benefit

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol could be shared for the purpose of a metaanalysis.

Impact of Immunoscore stratification on lymph node invasion rate in patients with secondary surgery

Impact of Immunoscore stratification combined to Histological risk factors on lymph node invasion rate

Assessment of Immunological features measured by RNA sequencing on tumor samples.

Assessment of molecular profile of the tumor by transcriptomic profile measured by RNAseq. CMS classification will be determined

National Cancer Institute, France

Ministry of Health, France

Assistance Publique - Hôpitaux de Paris

Carcinoma

Adenocarcinoma

Colonic Neoplasms

Immunoscore® is a tissue-based immune test that measures the host's immune response at the site of the tumor. It is performed on formalin-fixed paraffin-embedded (FFPE) tumor tissue samples from resections of localized colon cancer. The test uses whole slide imaging and artificial intelligence algorithms for assessment of the type, density, and location of T cells in FFPE tumor sections to determine an individual Immunoscore® for each patient.

Camila M Moniz, PhD

Ingrid P Barbosa

Lucila S Rocha, MD

Mariana B Siqueira, MD

Paulo M Hoff, PhD

Fernando A Soares, PhD

The proposed study is a bidirectional analytical study, composed of a retrospective and a prospective cohorts. Patients with stage II - III colorectal cancer undergoing oncological surgery will be analyzed. The study will include a convenience sample of 100 individuals. Fifty cases will be included retrospectively and fifty prospectively.

The study aims to evaluate the benefit of using the Immunoscore test as a predictor of recurrence in patients with operated stage II-III colon tumors. It will also be evaluated the impact on oncologic decision and costs.

Colorectal cancer resection surgical biospecimen

Role of Immunoscore® in Stage II-III Colorectal Cancer

Impact of Immunoscore stratification on tumor recurrence at 2 years

Impact of Immunoscore stratification on DFS at 5 years

Impact of Immunoscore stratification on OS at 5 years

Impact of Immunoscore stratification on DFS in right and left tumors at 3 years

Impact of Immunoscore stratification on OS in right and left tumors at 3 years

Percentage of patients who had an indication for adjuvant therapy through the evaluation of medical prescriptions

Correlation of Immunoscore stratification with the KRAS, NRAS and BRAF status

Difference in monetary value due to Immuno Score stratification and chemotherapy indication

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Personalized Medicine in Early Stage Colorectal Cancer: Organ Preservation and Immune Benefit	NCT06251726	Colorectal Canc...	Immunoscore Col...	18 Years -	Assistance Publique - Hôpitaux de Paris
Role of Immunoscore® in Stage II-III Colorectal Cancer	NCT05422547	Colon Adenocarc...	Immunoscore Col...	-	D'Or Institute for Research and Education

Spots Global Cancer Trial Database for immunoscore colon test