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

NCT06218108 | Unknown

• 1 other identifier: TAUTEM-pT1
• Study Type: observational
• Target: 317
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

T1 Rectal Adenocarcinoma; Early invasive rectal adenocarcinoma; TEM; Submucosal invasion; Prognosis of T1 rectal adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Taulí-T1 versus conventional classifications

  Compare the Taulí-T1 classification versus the conventional quantitative methods (Kitajima, Ueno) and qualitative ones (sm1, sm2 and sm3 of Kudo and Kikuchi), to classify the stage pT1 rectal adenocarcinomas.

  30 days

Interventions

Taulí-T1 versus conventional classifications DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort of patients diagnosed with rectal cancer who underwent surgery using transanal endoscopic surgery technique (TME, TEO or TAMIS) and histopathologically diagnosed with stage pT1 rectal adenocarcinoma. Patients who have received prior neoadjuvant treatment (radiotherapy and/or chemotherapy) will also be included, but both histological findings and their recurrence and survival data will be analyzed separately.

You may qualify if:

• Rectal adenocarcinoma.
• Histopathologically diagnosed with stage pT1.
• Patients treated with transanal endoscopic surgery technique (TME, TEO or TAMIS).
• Patients who have received prior neoadjuvant treatment (radiotherapy and/or chemotherapy).
• Over 18 years.

You may not qualify if:

• Patients treated with other surgical techniques other than transanal endoscopic surgery.
• Tumors other than adenocarcinoma.
• Locations other than rectum.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Hospital Universitario Parc Tauli de Sabadell

Sabadell, Barcelona, 08208, Spain

RECRUITING

Related Publications (2)

• Casalots A, Serra-Aracil X, Mora-Lopez L, Garcia-Nalda A, Pericay C, Ferreres JC, Navarro-Soto S. T1 Rectal Adenocarcinoma: a Different Way to Measure Tumoral Invasion Based on the Healthy Residual Submucosa with Its Prognosis and Therapeutic Implications. J Gastrointest Surg. 2021 Oct;25(10):2660-2667. doi: 10.1007/s11605-021-04948-9. Epub 2021 Feb 24.

  PMID: 33629231 BACKGROUND

• Gener-Jorge C, Ferreres Pinas JC, Moreno Garcia AB, Melgar Rivera DS, Casalots A, Nonell A, Espina B, Caro-Tarrago A, Serra-Aracil X. Interobserver agreement of the Tauli-pT1 classification in rectal pT1 adenocarcinoma. Int J Colorectal Dis. 2025 Sep 17;40(1):201. doi: 10.1007/s00384-025-04996-6.

  PMID: 40957973 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Histological samples

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Xavier Serra-Aracil, MD, PhD

  Corporacio Parc Tauli. Parc Tauli University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier Serra-Aracil, MD, PhD

CONTACT

34-93-723-1010; jserraa@tauli.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Colorectal Research Group

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 23, 2024
• Study Start: October 2, 2023
• Primary Completion: October 6, 2025
• Study Completion: January 5, 2026
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)