QOL and Sarcopenia in Patients With Ascites

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT05726747
Status
Recruiting
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Conditions

  • Ascites Hepatic
  • Ascites, Malignant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Quality of Life surveys — DIAGNOSTIC_TEST
    QoL and sarcopenia assessments

Study Details

Clinical data regarding quality of life in patients with refractory ascites is limited and preceded the development of newer questionnaires that may be more robust. One primary objective of this study is to study changes in quality in life in a prospective fashion using newer general and ascites-specific quality of life survey instruments specific to benign and malignant etiologies. Sarcopenia is a condition that is prevalent in cancer and cirrhosis. Current data is retrospective and associative, evaluating heterogeneous patient populations at different stages within the timeline of refractory ascites. The other primary objective of this study is to study sarcopenia in a prospective fashion and to understand its kinetics once a patient develops refractory ascites. Prospectively-obtained measures of deterioration in patient-reported outcomes and in muscle mass will form the basis for the next stage of investigation of interventions to mitigate these declines.

Key Dates

Start date
May 23, 2023
Status verified
Aug 2025
Primary completion
Apr 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
70 participants (estimated)

Primary Outcome Measure

Health-Related Quality of Life scores as measured by the PROMIS-10 questionnaire [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pennsylvania Perelman School of MedicinePhiladelphiaPennsylvania19104
Matthew Hung, MD
[email protected]
631-258-3849

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By research site
University of Pennsylvania Perelman School of Medicine· Philadelphia, PA

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