Prognostic Value of the Lymphocytic Infiltrate in Colon Cancers

Colorectal Cancer Clinical Trial

— TIL  

Official title:

Prognostic Value of the Lymphocytic Infiltrate in Colon Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02557061
• Other study ID #: 2008/118/HP
• Status: Completed
• Phase: N/A
• First received: September 21, 2015
• Last updated: October 7, 2016
• Start date: April 2009
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with tumor infiltrate by T-lymphocytes (CD3+)		Day 1	No
Primary	Number of alive patients		2 years	Yes
Secondary	Rate of preoperative blood T-lymphocytes		day 1 before resection	No