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NCT Number: NCT05452382

Surgical Outcome and Predictors of Overall Survival of Stage I-III Appendiceal Adenocarcinoma

A few studies investigated the predictors of overall survival in appendiceal adenocarcinoma. A SEER database analysis of 1404 patients with appendiceal adenocarcinoma found that older age, T4 tumors, N1-2 stage, poorly differentiated carcinoma, and distant metastasis were significantly predictive of poorer survival. Another small single-center study including 49 appendiceal cancer patients reported female gender and low-grade adenocarcinoma to be associated with increased overall survival. However, these previous analyses did not take into account some important prognosticators of survival such as patients' comorbidities and functional status, pathologic parameters such as lymphovascular invasion, and adjuvant systemic treatment. Therefore, we used the National Cancer Database (NCDB) to conduct a comprehensive analysis of the predictors of overall survival after surgical treatment of stage I-III appendiceal adenocarcinoma.

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Key information

Conditions

Appendiceal Cancer Appendiceal Neoplasms Cecal Diseases Cecal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Flroida

Weston, Florida, 33331, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with non-metastatic appendiceal adenocarcinoma who underwent surgical resection

Exclusion criteria

  • Patients with other pathologic types of appendiceal cancer
  • Patients with clinical stage IV or unknown stage
  • Patients who did not undergo surgery, underwent local excision, or had unknown/non-specified surgery

Treatment and study plan

Partial colecctomy

Procedure

Segmental resection of appendiceal adenocarcinoma including terminal ileum and cecum

Hemicolectomy

Procedure

Formal right hemicolectomy including terminal ileum, cecum, and ascending colon

Primary outcomes

  1. Overall survival

    Time frame: 60 months

    Percent of patients who were alive at five years of follow-up

Secondary outcomes

  1. Positive resection margins

    Time frame: Immediate postoperative

    the rate of surgical margins infiltrated by malignancy

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Collaborators

  • Cleveland Clinic Florida

Registry information

Official study title

Surgical Outcome and Predictors of Overall Survival of Stage I-III Appendiceal Adenocarcinoma; a National Cancer Database Analysis

Important dates

Study start
2005
Primary completion
2019
Study completion
2022
First posted
Jul 11, 2022
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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