Rectal Cancer Stage ITAUTEM-pT1NCT06218108
Multicenter Observational Study Taulí-T1 Classification for the Management of pT1 Rectal Adenocarcinoma
An observational study of Rectal Cancer Stage I, run by Corporacion Parc Tauli at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer Stage I
- What is being tested?
- Taulí-T1 versus conventional classifications
- How many people
- 317 participants
- Where
- 1 siteSpain
- Study dates
- 2 Oct 2023to 5 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients treated with other surgical techniques other than transanal endoscopic surgery.
- Tumors other than adenocarcinoma.
- Locations other than rectum.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Parc Tauli de Sabadell
Sabadell, Barcelona, 08208
Xavier Serra-Aracil, MD, PhD, 937 231 010 ext. 21490, jserraa@tauli.cat
About this study
Official title: 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.
Read the 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).
- Conditions
- Rectal Cancer Stage I
- Being tested
- Taulí-T1 versus conventional classifications
- Keywords
- T1 Rectal Adenocarcinoma, Early invasive rectal adenocarcinoma, TEM, Submucosal invasion, Prognosis of T1 rectal adenocarcinoma
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taulí-T1 versus conventional classificationsDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start2 Oct 2023
- Primary completion6 Oct 2025 (estimated)
- Study completion5 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal Cancer Stage IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 317 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier Serra-Aracil, Corporacion Parc Tauli
- Investigators
- Xavier Serra-Aracil, MD, PhD, Principal investigator, Corporacio Parc Tauli. Parc Tauli University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218108
- Sponsor's protocol ID
- TAUTEM-pT1
- Acronym
- TAUTEM-pT1
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33629231Gener-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.
PubMed 40957973
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Observational Study on the Taulí-T1 Classification for Staging, Prognosis, and Management of pT1 Rectal Adenocarcinoma (TAUTEM-pT1 Study)
- ClinicalTrials.gov ID
- NCT06218108
- Acronym / sponsor ID
- TAUTEM-pT1 / TAUTEM-pT1
- Conditions
- Rectal Cancer Stage I
- Keywords
- T1 Rectal Adenocarcinoma, Early invasive rectal adenocarcinoma, TEM, Submucosal invasion, Prognosis of T1 rectal adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 317 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 6 Oct 2025 (estimated)
- Study completion
- 5 Jan 2026 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients treated with other surgical techniques other than transanal endoscopic surgery.
- Tumors other than adenocarcinoma.
- Locations other than rectum.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taulí-T1 versus conventional classificationsAll 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. | Diagnostic test | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 33629231Casalots 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.
- Derived from this study: PubMed 40957973Gener-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Serra-Aracil, MD, PhD principal investigator
Corporacio Parc Tauli. Parc Tauli University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer Stage I, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier Serra-Aracil, MD, PhD (34-93-723-1010 ext. 21490, jserraa@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taulí-T1 versus conventional classifications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06218108, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.