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Prognostic Value of the Lymphocytic Infiltrate in Colon Cancers (TIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02557061
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : October 10, 2016
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:

Colorectal cancer (CRC) is one of the most common cancers in France (36,000 new cases / year) and nearly 16,000 people die each year from this disease. The lymph node involvement of the surgical specimen is today the main tool on which is based the adjuvant treatment decision after curative surgical resection. The study of new predictive factors to identify patients at risk for developing a local or metastatic recurrence is therefore a major challenge.

It is now clear that the immune system plays a role in the control of tumor's development, and it was shown that there was a correlation between the presence of a CD3+ T-lymphocyte infiltrate in colorectal cancers and patient survival. Preliminary studies suggest an important role of regulatory T-lymphocyte in the modulation of the antitumor immune response. The aim of our study is to follow a cohort of patients operated for colon cancer with curative intent to highlight the prognostic characteristics of the tumoral infiltrate by various lymphocyte populations (particularly T-lymphocytes but also B-lymphocytes and regulatory lymphocytes). It will be performed a preoperative analysis of blood circulating lymphocytes with antibodies specific for different cell populations (CD3, CD4, CD8, CD56, CD16, CD19, CD2) and stage of activation (CD25, CD69, HLA-DR ) or differentiation (CD24, CD38, CD27, CD103, CD62L, CCR7, CD45RA / RO, IgD). The presence of regulatory T-lymphocytes will also be analyzed. It will be performed on tumor sample a Tissue Microarrays for immunohistochemical study to determine the presence of different lymphocyte populations. We systematically study the markers CD68 (monocytes / macrophages), CD56 (NK cells), CD20 and CD79a (B cells / plasma cells), CD3 (T cells), CD8 (cytotoxic T), CD4 (helper T) FoxP3 (regulatory T), cytotoxicity of CD8 markers (Fas ligand, perforin and granzyme) and MHC I (antigen presentation) to explore the innate and adaptive immune responses. For each section, the different zones will be analyzed (center and invasive margin and healthy tissue). The main objective of the study is the influence of the tumor infiltration rate by CD3 + T cells on disease free survival at 2-years in patients with non-metastatic colon cancer resection. The secondary objective is to search a correlation between the rate of T-lymphocytes on preoperative blood sample and on tumor sample.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: Colorectal surgery (resection) Biological: Blood sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prognostic Value of the Lymphocytic Infiltrate in Colon Cancers
Study Start Date : April 2009
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Experimental: Patient with colorectal cancer
Colorectal surgery (resection) and blood sampling are done for patient with colorectal cancer
Procedure: Colorectal surgery (resection)
Colorectal surgery (resection) is done for patient with colorectal cancer

Biological: Blood sampling
Pre-operative blood sampling is done for patient with colorectal cancer

Primary Outcome Measures :
  1. Number of patients with tumor infiltrate by T-lymphocytes (CD3+) [ Time Frame: Day 1 ]
  2. Number of alive patients [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Rate of preoperative blood T-lymphocytes [ Time Frame: day 1 before resection ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient is male or female, and > 18 years of age
  • Patients with nonmetastatic colon cancer histologically proven (stage I, II or III).
  • Patients with curative resection (R0).
  • Patient has agreed to participate by giving written informed consent
  • Patient affiliated to the social security system

Exclusion Criteria:

  • Pregnant or without effective contraception and reproductive age.
  • Patients with synchronous metastatic disease at preoperative assessment (including at least an abdominal ultrasound and chest X-ray (or thoraco-abdominopelvic CT).
  • Patient taking immunosuppressive therapy.
  • Patient with lymphoid hematological disease.
  • Patients with rectal cancer defined by tumor accessible to finger and requiring preoperative radiotherapy (except tumor of upper rectum or rectosigmoid or rectal tumor operated without preoperative radiotherapy)
  • Patient under guardianship.
  • Patient misunderstanding spoken and written French.
  • Patient unable to submit to monitoring study for geographical, social or psychological reasons.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02557061

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Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
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Principal Investigator: David SEFRIOUI, MD Rouen University Hospital
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Responsible Party: University Hospital, Rouen Identifier: NCT02557061    
Other Study ID Numbers: 2008/118/HP
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases