Colorectal Cancer
Conditions
Keywords
Immunoscore, Tumor biomarkers, Organ preservation, Endoscopic submucosal dissection
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTImmunoscore Colon Test
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.
Sponsors
National Cancer Institute, France
Ministry of Health, France
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (\>18 years old) * patient with Stage T1 colorectal tumor * treated by endoscopic resection between 2014 and 2019 in one of the participating sites * sample of the resected tumor available for central analysis
Exclusion criteria
* Other Synchronous cancer * Synchronous CRC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lymph node invasion rate | time of histological examination of the surgical specimen | Impact of Immunoscore stratification on lymph node invasion rate in patients with secondary surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lymph node invasion rate | time of histological examination of the surgical specimen | Impact of Immunoscore stratification combined to Histological risk factors on lymph node invasion rate |
| Microenvironnement Immunologic parameters | Up to 3 years | Assessment of Immunological features measured by RNA sequencing on tumor samples. |
| Molecular profile of the tumor | Up to 3 years | Assessment of molecular profile of the tumor by transcriptomic profile measured by RNAseq. CMS classification will be determined |
Countries
France
Contacts
Primary ContactTouria El Aamri
Backup ContactYvann Frigout
Outcome results
None listed