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RECRUITINGNCT05726747

QOL and Sarcopenia in Patients With Ascites

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...

Lead sponsor: Abramson Cancer Center at Penn Medicine•1 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Michael C Soulen, MD

CONTACT

2154218647 [email protected]

Kathleen Thomas, MS

CONTACT

215-746-0352 [email protected]

Sponsors

Lead Sponsor

Abramson Cancer Center at Penn Medicine

Patients with refractory ascites defined as requiring \>1 paracentesis within a 6 week period will be prospectively enrolled. The Patient-Reported Outcomes Measurement Information System (PROMIS-10) and ascites-specific (Ascites Q and Edmonton Symptom Assessment System: Ascites Modification) quality of life questionnaires will be obtained at baseline, then at 1-, 2-, 4- and 6 months. Sarcopenia will be assessed by muscle area measurement from a single CT image at the L4 level at baseline, 2- and 6 months.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•1. Age \>/=18
•2. Eastern Cooperative Oncology Group (ECOG) performance score \< 3
•3. Refractory ascites due to cirrhosis or malignancy, requiring more than 1 therapeutic paracentesis in a 6 week period within 3 months of enrollment.
•4. Capable of giving informed consent

Exclusion Criteria

•1. Life expectancy less than 3 months
•2. Unable to participate in neuropsychological tests/questionnaires
•3. Pregnant or nursing women. .

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 29, 2025Terms

Trial snapshot

StatusRECRUITING

Phase—

Enrollment70

Start dateMay 2023

Last updatedAug 29, 2025

Condition

Ascites Hepatic Ascites, Malignant

Locations shown

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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