Solid Cancer in a Palliative Situation With AscitesAGASA-SPNCT03463655
Serum-Ascites Albumin Gradient Analysis in Cancer Patients in Palliative Care
An observational study of Solid Cancer in a Palliative Situation With Ascites, run by Institut Paoli-Calmettes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancer in a Palliative Situation With Ascites
- What is being tested?
- cirrhotic albumin and serum albumin
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 21 Dec 2017to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All HDJ, UAI, and the 3 medical oncology departments patients who have ascites puncture may be included.
Who may be able to join
- Patient over 18 years of age followed for a solid cancer in a palliative metastatic situation who had a puncture of ascites.
Who cannot join
- Minor patient
- Known cirrhosis
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut Paoli Calmettes
Marseille, Bouches Du Rhone, 13009
Dominique GENRE, MD, 33 4 91 22 37 78, drci.up@ipc.unicancer.fr
About this study
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.
Read the 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.
- Being tested
- cirrhotic albumin, serum albumin
- Keywords
- palliative, solid tumor, ascites
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cirrhotic albuminDiagnostic test
Ascites puncture
serum albuminDiagnostic test
blood punctures
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: cirrhotic albumin; Diagnostic Test: serum albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum-Ascites Albumin Gradient Prevalence
Elevated Serum-Ascites Albumin Gradient Prevalence in Palliative Cancer Patients
Measured: 3 months
Secondary outcomes (1)
Metastatic sites
Number of Metastatic sites of patients with a high gradient.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start21 Dec 2017
- Primary completionMar 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Solid Cancer in a Palliative Situation With AscitesStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélien PROUX, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463655
- Sponsor's protocol ID
- AGASA-SP-IPC 2017-004
- Acronym
- AGASA-SP
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24406314Guide pratique des soins palliatifs Edition A.P.E.S. (2008)
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.
PubMed 17298959
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum-Ascites Albumin Gradient Analysis in Cancer Patients in Palliative Care
- ClinicalTrials.gov ID
- NCT03463655
- Acronym / sponsor ID
- AGASA-SP / AGASA-SP-IPC 2017-004
- Keywords
- palliative, solid tumor, ascites
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| solid cancer in a palliative situation with ascites | – | Diagnostic Test: cirrhotic albumin, Diagnostic Test: serum albuminPatient over the age of 18, followed for a solid cancer in a palliative metastatic situation, having had a puncture of ascites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All HDJ, UAI, and the 3 medical oncology departments patients who have ascites puncture may be included.
Key inclusion criteria (1 listed)
- Patient over 18 years of age followed for a solid cancer in a palliative metastatic situation who had a puncture of ascites.
Key exclusion criteria (2 listed)
- Minor patient
- Known cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cirrhotic albuminAscites puncture | Diagnostic test | solid cancer in a palliative situation with ascites |
| serum albuminblood punctures | Diagnostic test | solid cancer in a palliative situation with ascites |
Primary outcome
Serum-Ascites Albumin Gradient Prevalence
Time frame: 3 months
Elevated Serum-Ascites Albumin Gradient Prevalence in Palliative Cancer Patients
1 secondary outcome
Metastatic sites
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Background: PubMed 24406314Carrier 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.
- BackgroundGuide pratique des soins palliatifs Edition A.P.E.S. (2008)
- Background: PubMed 17298959Ayantunde 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélien PROUX principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Cancer in a Palliative Situation With Ascites, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurélien PROUX (0491227643, PROUXA@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum-Ascites Albumin Gradient Prevalence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03463655, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.