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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Colorectal surgery (resection)
Blood sampling
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rouen University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with colorectal cancer

Arm Description

Colorectal surgery (resection) and blood sampling are done for patient with colorectal cancer

Outcomes

Primary Outcome Measures

Number of patients with tumor infiltrate by T-lymphocytes (CD3+)
Number of alive patients

Secondary Outcome Measures

Rate of preoperative blood T-lymphocytes

Full Information

First Posted
September 21, 2015
Last Updated
October 7, 2016
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT02557061
Brief Title
Prognostic Value of the Lymphocytic Infiltrate in Colon Cancers
Acronym
TIL
Official Title
Prognostic Value of the Lymphocytic Infiltrate in Colon Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient with colorectal cancer
Arm Type
Experimental
Arm Description
Colorectal surgery (resection) and blood sampling are done for patient with colorectal cancer
Intervention Type
Procedure
Intervention Name(s)
Colorectal surgery (resection)
Intervention Description
Colorectal surgery (resection) is done for patient with colorectal cancer
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Description
Pre-operative blood sampling is done for patient with colorectal cancer
Primary Outcome Measure Information:
Title
Number of patients with tumor infiltrate by T-lymphocytes (CD3+)
Time Frame
Day 1
Title
Number of alive patients
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Rate of preoperative blood T-lymphocytes
Time Frame
day 1 before resection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David SEFRIOUI, MD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

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Prognostic Value of the Lymphocytic Infiltrate in Colon Cancers

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