DataBase for Analysis of Rectal Cancer Oncological Results

NCT04947020 | Completed DMC

• 1 other identifier: BARO Trial
• Study Type: observational
• Target: 2,443
• Locations: 1 country
• Sites: 1

Brief 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:
• Establishing whether neoadjuvant treatment (PSCR or chemoradiotherapy) influences number of retrieved lymph nodes in rectal cancer
• Establishing whether time-interval between the end of PSCR and surgery influences lymph node yield
• Establishing the prognostic value of lymph node ratio - validation of the previously calculated cutoff point at the level of 0.41
• 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

Rectal Cancer; Metformin; Overall Survival; Lymph Node Metastases; Disease-free Survival

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival of analysed patients

  3 years

Secondary Outcomes (1)

• Disease-free survival

  3 years

Other Outcomes (2)

• Lymph node yield

  3 years

• Lymph node ratio

  3 years

Study Arms (1)

Rectal cancer

Patients with primary rectal cancer operated on between 2013 and 2019.

Drug: Metformin

Interventions

Metformin DRUG

Metformin use before operation due to previously diagnosed diabetes.

Also known as: Avamina, Etform, Formetic, Glucophage, Metfogamma, Metformax, Siofor, Symformin

Rectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with primary rectal cancer operated on between 2013 and 2019.

You may qualify if:

• Primary rectal cancer confirmed histologically
• Age ≥ 18

You may not qualify if:

• Recurrent rectal cancer
• Oncological radicalization after previous local excision of rectal cancer

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

1st Department of General Surgery

Krakow, Malopolska, 31-501, Poland

Location

MeSH Terms

Conditions

Rectal Neoplasms; Lymphatic Metastasis

Interventions

Metformin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Radoslaw Pach, PhD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

• Antoni Szczepanik, PhD

  Jagiellonian University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 1, 2021
• Study Start: August 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)