NCT03463655

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

March 5, 2018

Last Update Submit

March 12, 2018

Conditions

Solid Cancer in a Palliative Situation With Ascites

Keywords

palliativesolid tumorascites

Outcome Measures

Primary Outcomes (1)

  • Serum-Ascites Albumin Gradient Prevalence

    Elevated Serum-Ascites Albumin Gradient Prevalence in Palliative Cancer Patients

    3 months

Secondary Outcomes (1)

  • Metastatic sites

    3 months

Study Arms (1)

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 albuminDiagnostic Test: serum albumin

Interventions

cirrhotic albuminDIAGNOSTIC_TEST

Ascites puncture

solid cancer in a palliative situation with ascites
serum albuminDIAGNOSTIC_TEST

blood punctures

solid cancer in a palliative situation with ascites

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • Minor patient
  • Known cirrhosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, 13009, France

RECRUITING

Related Publications (3)

  • Carrier P, Jacques J, Debette-Gratien M, Legros R, Sarabi M, Vidal E, Sautereau D, Bezanahary H, Ly KH, Loustaud-Ratti V. [Non-cirrhotic ascites: pathophysiology, diagnosis and etiology]. Rev Med Interne. 2014 Jun;35(6):365-71. doi: 10.1016/j.revmed.2013.12.001. Epub 2014 Jan 6. French.

    PMID: 24406314BACKGROUND

  • Guide pratique des soins palliatifs Edition A.P.E.S. (2008)

    BACKGROUND

  • Ayantunde AA, Parsons SL. Pattern and prognostic factors in patients with malignant ascites: a retrospective study. Ann Oncol. 2007 May;18(5):945-9. doi: 10.1093/annonc/mdl499. Epub 2007 Feb 13.

    PMID: 17298959BACKGROUND

MeSH Terms

Conditions

Ascites

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Aurélien PROUX

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurélien PROUX

CONTACT

0491227643PROUXA@ipc.unicancer.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 13, 2018

Study Start

December 21, 2017

Primary Completion

March 1, 2018

Study Completion

April 1, 2018

Last Updated

March 13, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)