Serum-Ascites Albumin Gradient Analysis in Cancer Patients in Palliative Care (AGASA-SP)

March 12, 2018 updated by: Institut Paoli-Calmettes
Current recommendations do not recommend the concomitant administration of albumin after ascites puncture in patients with ascites neoplasia unlike cirrhotic ascites. The etiology of ascites in cancer patients is multifactorial, particularly by hepatic invasion that can lead to ascites loaded with albumin. Ascites punctures therefore lead to undernutrition, recurrent early ascites by decreasing the oncotic pressure by hypo albuminemia and a state of anasarca affecting the quality of life.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

According to the recommendations, each ascites fluid must be sent for biochemical and bacteriological analysis.

Demonstrate the high gradient proportion (percent only, no threshold of significance required). The literature has already validated the importance of supplementing albumen with cirrhotic ascites. Demonstrating that some cancer patients have high gradients, this will be enough to make the practitioner think to supplement.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bouches Du Rhone
      • Marseille, Bouches Du Rhone, France, 13009
        • Recruiting
        • Institut Paoli Calmettes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All HDJ, UAI, and the 3 medical oncology departments patients who have ascites puncture may be included.

Description

Inclusion Criteria:

  • Patient over 18 years of age followed for a solid cancer in a palliative metastatic situation who had a puncture of ascites.

Exclusion Criteria:

  • Minor patient
  • Known cirrhosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
solid cancer in a palliative situation with ascites
Patient over the age of 18, followed for a solid cancer in a palliative metastatic situation, having had a puncture of ascites.
Diagnostic test: cirrhotic albumin
Ascites puncture
Diagnostic test: serum albumin
blood punctures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum-Ascites Albumin Gradient Prevalence
Time Frame: 3 months
Elevated Serum-Ascites Albumin Gradient Prevalence in Palliative Cancer Patients
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metastatic sites
Time Frame: 3 months
Number of Metastatic sites of patients with a high gradient.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Aurélien PROUX, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2017

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 13, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGASA-SP-IPC 2017-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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