NCT03606317

Brief Summary

The objective is to perform a retrospective chart review of patients with cachexia related to cancer in patients treated at UT Southwestern Medical Center and Parkland Hospital to evaluate the prognosis and practice patterns in management of cachexia and associated symptoms.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Nov 2013

Longer than P75 for all trials

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Nov 2013Mar 2027

Study Start

First participant enrolled

November 26, 2013

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

13.3 years

First QC Date

May 18, 2018

Last Update Submit

April 17, 2026

Conditions

Keywords

Lung and gastrointestinal malignancies

Outcome Measures

Primary Outcomes (1)

  • Prognosis and practice patterns in the management of cachexia and its associated symptoms.

    This study involves no treatment or invasive procedures. The chart review will attempt to characterize lung and gastrointestinal cancer related cachexia including both primary treatment and treatment at the time of recurrence. Interventions in cachectic patients for weight control including nutritional support and supplements, pain control, anti-inflammatory medications, and appetite stimulants will be tracked along with clinical markers, including weight and laboratory values.

    10 years

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects medical charts will be identified in the medical record data warehouses with diagnosis of lung or gastrointestinal cancer during the above time frame. Data from charts will be entered into a password protected excel spreadsheet. The charts will be identified by name, medical record number, and date of birth. These are all patients treated by all hospitals and clinics affiliated with the Parkland and UT Southwestern Health Systems. At the time of study, many of the patients will have expired but some will be alive and in the regional North Texas area. Thus, given the fact the majority of patients will have expired at the time of this study and the minimal risk nature of this retrospective chart review, we could not reasonably conduct this research with a full waiver of consent.

You may qualify if:

  • Medical charts representing patients with a diagnosis of lung or gastrointestinal cancer with a tissue diagnosis from 1/1/2005 and onward treated at UT Southwestern or Parkland.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cachexia

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Study Officials

  • Linda A Gilmore

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 18, 2018

First Posted

July 30, 2018

Study Start

November 26, 2013

Primary Completion (Estimated)

March 18, 2027

Study Completion (Estimated)

March 18, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04