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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03463655
Recruitment Status : Unknown
Verified March 2018 by Institut Paoli-Calmettes.
Recruitment status was:  Recruiting
First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Solid Cancer in a Palliative Situation With Ascites Diagnostic Test: cirrhotic albumin Diagnostic Test: serum albumin

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 Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serum-Ascites Albumin Gradient Analysis in Cancer Patients in Palliative Care
Actual Study Start Date : December 21, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Serum-Ascites Albumin Gradient Prevalence [ Time Frame: 3 months ]
    Elevated Serum-Ascites Albumin Gradient Prevalence in Palliative Cancer Patients


Secondary Outcome Measures :
  1. Metastatic sites [ Time Frame: 3 months ]
    Number of Metastatic sites of patients with a high gradient.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463655


Contacts
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Contact: Aurélien PROUX 0491227643 PROUXA@ipc.unicancer.fr

Locations
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France
Institut Paoli Calmettes Recruiting
Marseille, Bouches Du Rhone, France, 13009
Contact: Dominique GENRE, MD    33 4 91 22 37 78    drci.up@ipc.unicancer.fr   
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
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Principal Investigator: Aurélien PROUX Institut Paoli-Calmettes
More Information
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Publications:
Guide pratique des soins palliatifs Edition A.P.E.S. (2008)

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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT03463655    
Other Study ID Numbers: AGASA-SP-IPC 2017-004
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Paoli-Calmettes:
palliative
solid tumor
ascites
Additional relevant MeSH terms:
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Ascites
Pathologic Processes