Serum-Ascites Albumin Gradient Analysis in Cancer Patients in Palliative Care

NCT ID: NCT03463655

Last Updated: 2018-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-21

Study Completion Date

2018-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Cancer in a Palliative Situation With Ascites

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

cirrhotic albumin

Intervention Type DIAGNOSTIC_TEST

Ascites puncture

serum albumin

Intervention Type DIAGNOSTIC_TEST

blood punctures

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cirrhotic albumin

Ascites puncture

Intervention Type DIAGNOSTIC_TEST

serum albumin

blood punctures

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aurélien PROUX

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aurélien PROUX

Role: CONTACT

0491227643

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dominique GENRE, MD

Role: primary

33 4 91 22 37 78

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24406314 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 17298959 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AGASA-SP-IPC 2017-004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.