The Prognostic Impact Of The Neutrophil To Lymphocyte Ratio In Patients With Locally Advanced Rectal Cancer

Not yet recruiting

• Conditions: the Prognostic Value of Pre-treatment NLR in Patients With Locally Advenced Rectal Cancer and Post-treatment

• Registration Number: NCT05673343
• Lead Sponsor: Assiut University

Brief Summary

In this study, we aim to investigate the prognostic value of pre-treatment NLR in patients with locally advenced rectal cancer and post-treatment

Detailed Description

Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide.\[1\] Rectal cancer accounts for 30% to 35% of CRCs\[2\], Between 5% and 10% of patients with rectal cancer present with locally advanced rectal cancer (LARC),\[3\] Useful and practical prognostic biomarkers obtained before treatment are anticipated to predict the outcome after main treatment. Such biomarkers will help in planning strategies for adjustment of postoperative adjuvant therapy.\[4\]

Inflammation-induced markers play an important role in tumorigenesis and tumor progression. More evidences had reported systemic inflammation-based biomarkers could be used to predict tumor behavior.\[4\] Two convenient and economic measures of systemic inflammation, neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), that reflect the interaction between inflammation and host immune status, making them potential prognostic factors for various types of cancers. Increased NLR has been advocated to be an independent prognostic factor for poor survival outcomes in pancreatic cancer, CRC, and gastric cancer \[5-6\].

In this study, we aim to investigate the prognostic value of pre-treatment NLR in patients with locally advenced rectal cancer and post-treatment

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-04
• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-01-04
• Last Update Submitted: 2023-01-04
• Study First Posted: 2023-01-06
• Last Update Posted: 2023-01-06
• Primary Completion: 2024-01-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients aged 18-year-old or more 2-Histopathologically proved to be rectal carcinoma. 3- locally advanced stage II and stage III according to AJCC TNM staging 8th edition 4- fit for concurrent chemoradiation therapy (CCRT) with adequate organ function.

5- Performance status 0-1 according to ECOG PS

Exclusion Criteria

• 1- metastatic disease 2- Younger than 18 year old 3-Any other malignancy 4-There is contraindication for CCRT

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
disease free-survival	2-5 yrs	defined as the time from the day of disease diagnosis until the day of disease failure.

Secondary Outcome Measures

Name	Time	Method
overall survival (OS	2-5 years	defined as the time from the day of disease diagnosis until the date of death.