Fact CheckerSign in

NCT04947020Completed

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 · Last updated 25 Feb 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Observational
Enrollment
2443 (actual)
First submitted
24 Jun 2021
Start date
1 Aug 2021
Primary completion date
30 Dec 2022
Lead sponsor
Jagiellonian University
NCT number
NCT04947020

What you commit to

  • Study type: Observational
  • Participants enrolled: 2443
  • From 1 Aug 2021 to the primary completion date, 30 Dec 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Oncological radicalization after previous local excision of rectal cancer

Other illness

  • Recurrent rectal cancer

Who the study is looking for

  • Primary rectal cancer confirmed histologically
  • Age ≥ 18

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
1st Department of General Surgery
Coordinator of this site? Confirm its status
KrakowPolandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.