Costimulatory and -inhibitory molecules on tumor-infiltrating lymphocytes from colorectal carcinoma and its metastases

Recruiting

• Conditions: bowel cancer; colorectal carcinoma; 10017991

• Registration Number: NL-OMON43140
• Lead Sponsor: Stichting Leveronderzoek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 677

Inclusion Criteria

Adult colorectal carcinoma (CRC) patients that will undergo surgery for CRC or its metastases

Exclusion Criteria

Patients who refuse blood donation/participation in the study
Patients with a severe immunocompromised condition, or patients taking immunosuppressive medication

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are:<br /><br>1) Frequencies and absolute numbers of different lymphocyte populations that<br /><br>together compose the tumor-infiltrating lymphocyte pool<br /><br>2) Expression of costimulatory and co-inhibitory molecules on TIL versus<br /><br>lymphocytes isolated from tumor-free tissue versus circulating lymphocytes<br /><br>3) Effect of blocking co-inhibitory molecules or stimulating costimulatory<br /><br>molecules expressed by TIL on their function (proliferation and cytokine<br /><br>production) in ex vivo culture experiments</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Depending on the co-inhibitory molecules detected on TIL, immunohistochemistry<br /><br>will be performed on residual formalin-fixed paraffin-embedded tumor tissue<br /><br>that is regularly stored to identify the expression of the ligands of these<br /><br>co-inhibitory molecules (e.g. PDL-1+2, GAL-9) on tumor (infiltrating) cells. If<br /><br>possible, lymph node (when part of excision preparation) will be analyzed.</p><br>