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NCT05893667 Clinical Trial

Evaluation of Inflammatory Markers in LARC Patients

Locally Advanced Rectal Cancer Clinical Trial

Official title:
Evaluation of Pretreatment Inflammatory Markers in Predicting Response to nCRT and Prognosis in LARC Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05893667
Other study ID # HPedroHispano
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date May 1, 2023

Study information
Verified date June 2023
Source Hospital Pedro Hispano
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Introduction: In locally advanced rectal cancers (LARC), TNM staging is far from optimal. We aimed to investigate the value of previously described circulating biomarkers as predictors of prognosis. Methods: Retrospective analysis of 245 LARC patients diagnosed between January 2010 and December 2022, who underwent neoadjuvant chemoradiotherapy and surgery at two centers. A Cox regression and Kaplan-Meier analysis were performed.

Recruitment information / eligibility
Status Completed
Enrollment 245
Est. completion date May 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - patients diagnosed pathologically with rectal adenocarcinomas, located within 12cm from the anal verge (measured by MRI), clinically staged T3-4 and/or N+ and treated with neoadjuvant chemoradiotherapy (nCRT) followed by radical surgery Exclusion Criteria: - evidence of distant metastasis at diagnosis, emergent or palliative surgery, local excision or "watch and wait" approach and evidence of inflammatory or hematological disorders

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Inflammatory markers
analysis of inflammatory scores

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital Pedro Hispano

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival Disease-free survival 5 years
Secondary Pathological response through Ryan Tumor Regression Grade TRG 1-5; 1- no viable cancer cells; 5- no fibrosis, with extensive residual disease at study completion, average of 5 years
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