MedTrace Logo

DataBase for Analysis of Rectal Cancer Oncological Results

NCT04947020 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2443

Last updated 2025-02-25

No results posted yet for this study

Summary

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

Interventions

DRUG

Metformin

Metformin use before operation due to previously diagnosed diabetes.

Sponsors & Collaborators

  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Radoslaw Pach, PhD · Jagiellonian University

  • Antoni Szczepanik, PhD · Jagiellonian University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-12-30
Completion
2024-12-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04947020 on ClinicalTrials.gov