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Completed

NCT Number: NCT05893667

Evaluation of Inflammatory Markers in LARC Patients

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.

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Key information

Conditions

Locally Advanced Rectal Cancer

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inflammatory markers

Diagnostic Test

analysis of inflammatory scores

Primary outcomes

  1. Overall survival Disease-free survival

    Time frame: 5 years

Secondary outcomes

  1. Pathological response through Ryan Tumor Regression Grade

    Time frame: at study completion, average of 5 years

    TRG 1-5; 1- no viable cancer cells; 5- no fibrosis, with extensive residual disease

Sponsors and collaborators

Lead sponsor

Hospital Pedro Hispano

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2022
Study completion
2023
First posted
Jun 8, 2023
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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