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Multicenter Observational Study Taulí-T1 Classification for the Management of pT1 Rectal Adenocarcinoma

NCT06218108 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 317

Last updated 2024-01-23

No results posted yet for this study

Summary

BACKGROUND: Rectal cancer is the sixth most common neoplasm in Spain. In the early stages (pT1-N0), the treatment of choice is transanal endoscopic microsurgery. Treatment may be expanded to radical surgery if there are poor prognostic factors for the presence of metastatic lymph nodes and a risk of recurrence (up to 29%). The most determining histopathological factor is the degree of submucosal invasion. There are different classical classifications to assess this invasion, which pose difficulties in establishing objective and reproducible measurements. Casalots et al. propose a new classification (Taulí-T1) based on the measurement of residual healthy submucosa (hrSB), hypothesizing that a greater amount of healthy submucosa correlates with a better prognosis. Results show less healthy submucosa in the recurrence group, with a trend towards statistical significance (p=0.09).

OBJECTIVE: To compare the Taulí-T1 classification with conventional quantitative classifications (Kitajima, Ueno) and qualitative classifications (sm1, sm2, and sm3 by Kudo and Kikuchi).

METHODOLOGY: A multicenter observational retrospective cohort study comparing the Taulí-T1 classification with classical classifications in 317 patients with stage pT1 rectal adenocarcinoma, following the STROBE guidelines. The main variable is the measurement of tumor invasion in µm through hrSB, compared to the invasion of quantitative (Kitajima and Ueno) and qualitative (Kudo and Kikuchi) classical classifications. Concordance will be assessed with the intraclass correlation coefficient for quantitative variables and Cohen's weighted kappa for qualitative variables, with a 95% confidence interval and p\<0.005.

Conditions

  • Rectal Cancer Stage I

Interventions

DIAGNOSTIC_TEST

Taulí-T1 versus conventional classifications

All the slides of each case will be reviewed, selecting the one that contains the most invasive section, and this will be digitized to take measurements in micrometers with greater precision. To measure the degree of infiltration, the measurement of residual healthy submucosa (hrSB) will be used, which is the distance between the point of greatest infiltration and the muscularis propria. The total thickness of the submucosa in the tumor area will also be measured, taking as a reference the muscularis of the mucosa or, in its absence, the surface of the lesion, to calculate the percentage of infiltration of the submucosa. This percentage will be calculated as the inverse percentage of invasion with respect to the hrSB: (total thickness of the submucosa - hrSB / total thickness of the submucosa) x 100. The qualitative categories will be obtained: sm1 (\< 33.3%), sm2 (33.3% - 66.6%) and sm3 (\> 66.6%). Measurements will be also taken in micrometers for the conventional classifications.

Sponsors & Collaborators

  • Corporacion Parc Tauli

    lead OTHER

Principal Investigators

  • Xavier Serra-Aracil, MD, PhD · Corporacio Parc Tauli. Parc Tauli University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2025-10-06
Completion
2026-01-05

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06218108 on ClinicalTrials.gov