BMI and Lymph Node Count in Colorectal Cancer

NCT06334926 | Completed DMC

• 1 other identifier: EK 18-002-VK
• Study Type: observational
• Target: 1,192
• Locations: 1 country
• Sites: 1

Brief Summary

Background and aim: Colorectal Cancer (CRC) is one of the most frequent cancer entities in the western world. It is known that obesity is one of the major risk factors for CRC. In contrast, mild obesity seems to have a positive effect on postoperative outcome, which is known as the "obesity paradox". Also, the number of resected lymph nodes (LN) during surgery is very important for correct staging. The aim of the present project is to evaluate the impact of BMI and LN-yield on long term overall survival (OS) of CRC patients treated with curative intent. Methods: Patients treated for CRC between 1998 and 2011 at the Klinik Favoriten in Vienna, Austria were analyzed in this retrospective single-center cohort analysis concerning OS.

Conditions

The Aim of This Study is to Determine the Influence of BMI and Lymph Node Status on OS in CRC Patients in the Long Term

Keywords

colorectal cancer, survival, prognostic factors, body mass index, obesity paradox, lymph node count

Outcome Measures

Primary Outcomes (1)

• overall survival

  The aim of the present project is to evaluate the impact of BMI and LN-yield on long term overall survival (OS) of CRC patients treated with curative intent.

  median follow up of 11.3 years

Study Arms (2)

Colon cancer patients

Retrospective data analysis of the subgroup of patients suffering from colon carcinoma

Other: no intervention, retrospective data analysis

Rectal cancer patients

Retrospective data analysis of the subgroup of patients suffering from rectal carcinoma

Other: no intervention, retrospective data analysis

Interventions

no intervention, retrospective data analysis OTHER

not applicable, retrospective data analysis

Colon cancer patients; Rectal cancer patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who had surgery at the department of surgery at the Klinik Favoriten between 1998 and 2011 were analyzed. 1192 patients met the inclusion criteria were therefore pseudonymized and recorded in a newly developed database.

You may qualify if:

• colorectal carcinoma
• treated at the Klinik Favoriten between 1998 and 2011
• elective or acute surgical setting
• curative intent
• older than 18 years

You may not qualify if:

• other carcinoma (anal, metastases, ...)
• treated before 1998 or after 2011
• palliative intent
• younger than 18 years

Sponsors & Collaborators

• Klinikum Floridsdorf: lead
• Medical University of Vienna: collaborator
• Klinik Favoriten: collaborator
• Salzkammergut Klinikum Vöcklabruck: collaborator

Study Sites (1)

Klinik Floridsdorf

Vienna, 1210, Austria

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Tamara Braunschmid, MD

  Klinik Floridsdorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 11 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: December 1, 2017
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)