Personalized Medicine in Early Stage Colorectal Cancer: Organ Preservation and Immune Benefit
- Conditions
- Colorectal Cancer
- Interventions
- Diagnostic Test: Immunoscore Colon Test
- Registration Number
- NCT06251726
- Lead Sponsor
- Assistance Publique - H么pitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 310
- 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
- Other Synchronous cancer
- Synchronous CRC
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort of patients with stage T1 CRC treated by primary endoscopic resection. Immunoscore Colon Test Secondary surgery is performed in patients with pejorative histopathologic feature(s) of the tumor.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Microenvironnement Immunologic parameters Up to 3 years Assessment of Immunological features measured by RNA sequencing on tumor samples.
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
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
Trial Locations
- Locations (1)
AP-HP - h么pital europ茅en Georges-Pompidou
馃嚝馃嚪Paris, France