NCT05893667

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

12.9 years

First QC Date

May 17, 2023

Last Update Submit

June 8, 2023

Conditions

Locally Advanced Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival Disease-free survival

    5 years

Secondary Outcomes (1)

  • Pathological response through Ryan Tumor Regression Grade

    at study completion, average of 5 years

Study Arms (2)

High levels of inflammatory scores

Diagnostic Test: Inflammatory markers

Low levels of inflammatory scores

Diagnostic Test: Inflammatory markers

Interventions

Inflammatory markersDIAGNOSTIC_TEST

analysis of inflammatory scores

High levels of inflammatory scoresLow levels of inflammatory scores

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

as in inclusion criteria

You may qualify if:

  • 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

You may not qualify if:

  • evidence of distant metastasis at diagnosis, emergent or palliative surgery, local excision or "watch and wait" approach and evidence of inflammatory or hematological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2023

First Posted

June 8, 2023

Study Start

January 1, 2010

Primary Completion

December 1, 2022

Study Completion

May 1, 2023

Last Updated

June 12, 2023

Record last verified: 2023-06