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Trial Title:
Personalized Medicine in Early Stage Colorectal Cancer: Organ Preservation and Immune Benefit
NCT ID:
NCT06251726
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Immunoscore
Tumor biomarkers
Organ preservation
Endoscopic submucosal dissection
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Immunoscore Colon Test
Description:
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.
Arm group label:
Cohort of patients with stage T1 CRC treated by primary endoscopic resection.
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.
Criteria for eligibility:
Study pop:
French multi-institutional cohort of patients with stage T1 CRC treated by primary
endoscopic resection
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AP-HP - hôpital européen Georges-Pompidou
Address:
City:
Paris
Zip:
75015
Country:
France
Contact:
Last name:
Franck PAGÈS, MD
Start date:
April 2024
Completion date:
December 2024
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute, France
Agency class:
Other
Collaborator:
Agency:
Ministry of Health, France
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06251726
