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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05115877
Other study ID # 031.HPB.2020.R
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 7, 2021
Est. completion date May 17, 2024

Study information

Verified date April 2023
Source Methodist Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will be a retrospective, registry study collecting data of patients who were diagnosed with benign or malignant gastrointestinal diseases. Data will be collected from patient's chart retrospectively once the patients have completed proper treatment follow up with physicians' practice.


Description:

It is reported in the literature that the treatment of any gastrointestinal disease process, whether benign or malignant, continues to be a huge challenge. For example, patients with gastrointestinal cancer continue to be diagnosed at an advanced stage with medical and surgical options that are improving in terms of outcome measurements but with much more room for improvement. The goal is to continue to review our treatment outcomes to further improve overall survival, overall symptom control, mortality and morbidity. The main aim of this study is to evaluate and compare the outcomes from our treatment of benign or malignant gastrointestinal diseases through medical chart review. There is a need to understand and improve the current diagnosis and treatment algorithm for gastrointestinal pathologies. Continued evaluation and study is imperative to ensure that national guidelines are improving to enhance patient cure and/or recovery.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1000
Est. completion date May 17, 2024
Est. primary completion date May 17, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients diagnosed and treated for gastrointestinal diseases, benign or malignant from 2005 to 2030. - Age =18 years Exclusion Criteria: - Patients that are not diagnosed with or treated for gastrointestinal diseases - Age <18 years

Study Design


Locations

Country Name City State
United States Methodist Richardson Medical Center Richardson Texas

Sponsors (1)

Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival from day of diagnosis or procedure to death date Jan 2005 - Jan 2030
Primary Overall symptom Difficulty swallowing, Heartburn, Regurgitation, Chest pain, Weight Loss, Quality of life Jan 2005 - Jan 2030
Primary Mortality death or life Jan 2005 - Jan 2030
Primary Morbidity yes or no to individual disease Jan 2005 - Jan 2030
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