Clinical Trials Logo

Clinical Trial Summary

The primary objective of COLON-IM is to describe colorectal tissue microenvironment (neutrophils infiltrate) of patients with benign or malignant colorectal lesion (from stage I to III according to Tumor Node Metastasis (TNM)/ Union for International Cancer Control (UICC) classification).


Clinical Trial Description

Colorectal cancers (CRC) are the most common gastrointestinal cancers in Western countries (both Europe and the US) ; they are both associated with significant morbidity and mortality. The 5-year survival is around 63.5% (including all stages). Sporadic colon cancers make up 85% of all colorectal adenocarcinoma. Preneoplastic lesions accumulate alterations in genes that regulate cell growth.

Patients suffering from CRC have a modified intestinal flora compared to healthy people. A specified microbiota profiled combined to genetic and immunological characteristics should be involved in colorectal carcinogenesis. Recent data have showed that responses to immunotherapies are associated with presence of certain bacteria in intestinal flora which potentially boost immune antitumor response.

Immunotherapy is highly efficient in tumors with high mutation load and Microsatellite Instability-High (MSI-H). MSI-H tumors represent 15% of local colorectal tumors. Today, it is important to understand all immune agents roles in colorectal carcinogenesis in order to describe new interesting immune checkpoints to target.

Tumor cells and tissues can escape immune surveillance and immune defense by several mechanisms. All immune cells subtypes present in the tumor, at the invasive tumor front and/or in tertiary lymphoid structures constitute the "immune context". The immune microenvironment has been shown to play a crucial role in disease progression, maintenance and resistance to therapy. All immune cells could play a pro-tumor or an anti-tumor role. For example, lymphocyte infiltrate is described as a prognostic factor in colorectal cancer : a tool (Immunoscore) has been validated as prognostic tool and it provides independent and superior prognostic value to TNM classification. This immune classification measures the host immune response at the tumor site and helps to guide treatment strategies.

Adaptative immunity is well known ; however, innate immunity should also play an early role during carcinogenesis. Role of neutrophils in the tumor microenvironment remains controversial, with evidence for both pro- and anti-tumor roles.Tumour-associated neutrophils (TANS) have an antitumorigenic in early stage of carcinogenesis or a protumorigenic functions in metastatic stage. Evidences indicate that neutrophils manifest functional plasticity during oncogenic process. Neutrophil-to-lymphocyte ratio is associated with patient prognosis ; a high ratio seems to be associated with poor prognostic.

Intestinal microbiota and immune infiltrate play key roles in colorectal microenvironment. Their interdependent interaction and their impacts on colorectal neoplasia and treatments are not well known. The primary objective of COLON-IM is to describe colorectal tissue microenvironment of patients with benign or malignant colorectal lesion (from stage I to III according to TNM/UICC classification). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03841799
Study type Observational
Source Centre Leon Berard
Contact Gwenaelle GARIN
Phone 04 26 55 68 24
Email gwenaelle.garin@lyon.unicancer.fr
Status Not yet recruiting
Phase
Start date March 2019
Completion date September 2022

See also
  Status Clinical Trial Phase
Recruiting NCT02963831 - A Phase 1/2 Study to Investigate the Safety, Biologic and Anti-tumor Activity of ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Recruiting NCT03167125 - Participatory Research to Advance Colon Cancer Prevention N/A
Recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Enrolling by invitation NCT03181334 - The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation N/A
Active, not recruiting NCT02876224 - Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors Phase 1
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A
Completed NCT01266564 - An Observational Study of Avastin (Bevacizumab) in Patients With Colorectal Cancer N/A
Recruiting NCT02857270 - A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer Phase 1
Withdrawn NCT00005030 - SCH 66336 Before Surgery in Treating Patients With Colorectal Cancer That Has Metastasized to the Liver Phase 1
Recruiting NCT03530267 - Aflibercept and 5-FU vs. FOLFOX as 1st Line Treatment for Elderly or Frail Elderly Patients With Met. Colorectal Cancer Phase 2
Recruiting NCT03422432 - Prophylactic HIPEC for Colorectal Cancers at High Risk of Developing Peritoneal Metastases N/A
Recruiting NCT03555149 - A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC) Phase 1/Phase 2
Recruiting NCT03214939 - Autologous Antigen-activated Dendritic Cells in the Treatment of Patients With Colorectal Cancer Early Phase 1
Active, not recruiting NCT01688232 - The Immunoscore as a Prognostic Marker for Patients With a Colorectal Cancer N/A
Recruiting NCT03602677 - Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage N/A
Active, not recruiting NCT00578721 - Trial of Aspirin and Arginine Restriction in Colorectal Cancer Phase 2
Recruiting NCT02386826 - INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme Phase 1
Terminated NCT02277093 - Pacritinib to Inhibit JAK/STAT Signaling in Refractory Colorectal Cancer Phase 2
Not yet recruiting NCT03083951 - Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL) Phase 4