Clinical trial · Observational
DataBase for Analysis of Rectal Cancer Oncological Results
Multicenter Retrospective Trial for Analysis of Oncological Results of Patients with Primary Rectal Cancer Operated on Between 2013-2019
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The data will be obtained from 10 tertiary centers located in Poland (Cracow - coordinating center, Warsaw - 3 centers, Sosnowiec, Szczecin, Bydgoszcz, Lublin, Gdansk, Poznan) and 5 foreign centers. The analyses will include patients with rectal cancer operated on between 2013-2019. A database in MS Excel is prepared that consists of following data: * Type of neoadjuvant treatment (if any) * Time-interval between the end of neoadjuvant treatment and surgery * Type of surgery * Staging of rectal cancer i.e. (y)pTNM * Number of retrieved lymph nodes * Number of lymph nodes with metastases * R classification (R0, R1, R2) * Preoperative medications (metformin, statins, NSAIDs, anticoagulants) * Recurrence date and type (local, systemic, both diagnosed at the same time) * Date of death or date of last follow-up visit The aims of the study are following: 1. Establishing whether neoadjuvant treatment (PSCR or chemoradiotherapy) influences number of retrieved lymph nodes in rectal cancer 2. Establishing whether time-interval between the end of PSCR and surgery influences lymph node yield 3. Establishing the prognostic value of lymph node ratio - validation of the previously calculated cutoff point at the level of 0.41 4. Determining independent prognostic factors in rectal cancer - in particular related to medications taken before the operation, metformin and anti diabetic drugs in the first place
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disease-free Survival | — | UNRESOLVED | — |
| Lymph Node Metastases | — | UNRESOLVED | — |
| Metformin | — | UNRESOLVED | — |
| Overall Survival | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Rectal cancer
- description
- Patients with primary rectal cancer operated on between 2013 and 2019.
- interventionNames
- Drug: Metformin
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 3 years
- description
- Overall survival of analysed patients
Secondary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 3 years
- description
- Disease-free survival of analysed patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Primary rectal cancer confirmed histologically * Age ≥ 18 Exclusion Criteria: * Recurrent rectal cancer * Oncological radicalization after previous local excision of rectal cancer
References
Publications (0)
Data not yet available