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

Rectal Cancer Stage I Clinical Trial

— TAUTEM-pT1  

Official title:

Multicenter Observational Study on the Taulí-T1 Classification for Staging, Prognosis, and Management of pT1 Rectal Adenocarcinoma (TAUTEM-pT1 Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06218108
• Other study ID #: TAUTEM-pT1
• Status: Recruiting
• Start date: October 2, 2023
• Est. completion date: January 5, 2026

Study information

• Verified date: January 2024
• Source: Corporacion Parc Tauli
• Contact: Xavier Serra-Aracil, MD, PhD
• Phone: 34-93-723-1010
• Email: jserraa[@]tauli.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

HYPOTHESIS: Taulí-T1 classification will have greater clinical utility to classify the stage pT1 rectal adenocarcinomas compared with conventional classifications.

OBJECTIVE: The main objective of the study is to compare the Taulí-T1 classification versus the conventional quantitative methods (Kitajima, Ueno) and qualitative ones (sm1, sm2 and sm3 of Kudo and Kikuchi), through a multicenter cohort study of the TAUTEM group.

STUDY DESIGN:

Multicenter observational retrospective cohort study that compares the Taulí-T1 classification with the classic classifications for stage pT1 of rectal adenocarcinoma.

The study participants will be 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. To calculate the sample size, an alpha error of 0.05 was used with a confidence level of 95%, with a precision of 0.05 and an estimate of the prevalence of pT1 recurrence of 29%. A sample of 317 patients will be required.

The main variable to be studied is the measurement of tumor invasion in µm by measuring the healthy residual submucosa (hrSB) with the Taulí-T1 classification, in comparison with the measurement of invasion of the classic quantitative (Kitajima and Ueno) and qualitative classifications (Kudo and Kikuchi).

The secondary variables to be assessed are: demographic and macroscopic data of the tumor and histopathological variables (tumor morphology, measurement of the submucosa in the area of the lesion and in the healthy area, presence or absence of muscularis mucosa and muscularis propria, assessment of resection margins, histological differentiation degree, presence of adenocarcinoma on adenoma, presence of poor prognostic factors -lymphatic, perineural and vascular invasion, tumor budding-). Surgical data will also be collected (type of surgery, location of the tumor and distance from the anal margin, integrity of the specimen) and clinical data (neoadjuvant treatment, recurrences, appearance of lymphadenopathy, survival).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 317
• Est. completion date: January 5, 2026
• Est. primary completion date: October 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients treated with other surgical techniques other than transanal endoscopic surgery.

• Tumors other than adenocarcinoma.

• Locations other than rectum.

Related Conditions & MeSH terms

• Adenocarcinoma
• Rectal Cancer Stage I

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Parc Tauli de Sabadell	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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