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

January 11, 2024 updated by: Xavier Serra-Aracil, Corporacion Parc Tauli

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Observational

Enrollment (Estimated)

317

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xavier Serra-Aracil, MD, PhD
  • Phone Number: 21490 34-93-723-1010
  • Email: jserraa@tauli.cat

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Hospital Universitario Parc Tauli de Sabadell
        • Contact:
          • Xavier Serra-Aracil, MD, PhD
          • Phone Number: 21490 937 231 010‬
          • Email: jserraa@tauli.cat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Taulí-T1 versus conventional classifications
Time Frame: 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Investigators

  • Principal Investigator: Xavier Serra-Aracil, MD, PhD, Corporacio Parc Tauli. Parc Tauli University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2023

Primary Completion (Estimated)

October 6, 2025

Study Completion (Estimated)

January 5, 2026

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Estimated)

January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAUTEM-pT1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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