Evaluation of Inflammatory Markers in LARC Patients

• Sponsor: Hospital Pedro Hispano (Other)
• Overall Status: Completed
• CT.gov ID: NCT05893667
• Collaborator: (none)
• Enrollment: 245
• Actual Duration (Months): 159.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Rectal Cancer	Diagnostic Test: Inflammatory markers

Study Design

• Study Type: Observational
• Actual Enrollment: 245 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Evaluation of Pretreatment Inflammatory Markers in Predicting Response to nCRT and Prognosis in LARC Patients
• Actual Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Dec 1, 2022
• Actual Study Completion Date: May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
High levels of inflammatory scores	Diagnostic Test: Inflammatory markers; analysis of inflammatory scores
Low levels of inflammatory scores	Diagnostic Test: Inflammatory markers; analysis of inflammatory scores

Outcome Measures

Primary Outcome Measures

1. Overall survival Disease-free survival [5 years]

Secondary Outcome Measures

1. Pathological response through Ryan Tumor Regression Grade [at study completion, average of 5 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hospital Pedro Hispano

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marina Morais, Principal Investigator, Hospital Pedro Hispano
• ClinicalTrials.gov Identifier: NCT05893667
• Other Study ID Numbers: HPedroHispano
• First Posted: Jun 8, 2023
• Last Update Posted: Jun 12, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Jun 12, 2023