Comparing new classification methods for early rectal cancer management
Multicenter Observational Study on the Taulí-T1 Classification for Staging, Prognosis, and Management of pT1 Rectal Adenocarcinoma (TAUTEM-pT1 Study)
Corporacion Parc Tauli · NCT06218108
This study is testing a new way to classify early rectal cancer to see if it can better predict outcomes for patients who have had surgery for this type of cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 317 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Corporacion Parc Tauli (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Sabadell, Barcelona) |
| Trial ID | NCT06218108 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the Taulí-T1 classification for managing pT1 rectal adenocarcinoma by comparing it with traditional classification methods. The study will involve a multicenter cohort of patients who have undergone transanal endoscopic surgery and have been histopathologically diagnosed with stage pT1 rectal adenocarcinoma. The primary focus is on measuring the healthy residual submucosa to determine its correlation with prognosis and recurrence rates. The study will analyze data from 317 patients to assess the effectiveness of the new classification in predicting outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with histopathologically diagnosed pT1 rectal adenocarcinoma who have undergone transanal endoscopic surgery.
Not a fit: Patients with rectal tumors other than adenocarcinoma or those treated with surgical techniques other than transanal endoscopic surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic accuracy and treatment strategies for patients with early-stage rectal cancer.
How similar studies have performed: While this approach is based on existing classifications, the specific Taulí-T1 classification is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Sabadell, Barcelona
- Hospital Universitario Parc Tauli de Sabadell — Sabadell, Barcelona, Spain (RECRUITING)
Study contacts
- Principal investigator: Xavier Serra-Aracil, MD, PhD — Corporacio Parc Tauli. Parc Tauli University Hospital
- Study coordinator: Xavier Serra-Aracil, MD, PhD
- Email: jserraa@tauli.cat
- Phone: 34-93-723-1010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rectal Cancer Stage I, T1 Rectal Adenocarcinoma, Early invasive rectal adenocarcinoma, TEM, Submucosal invasion, Prognosis of T1 rectal adenocarcinoma