AscitesNCT03205748
Evaluation of Different Etiologies of Obscure Ascites
An observational study of Ascites, run by Assiut University at 1 site in Egypt.
Trial summary
Ascites refers to fluid that accumulates within the peritoneal cavity. Although ascites is most commonly observed in patients with cirrhosis and resulting portal hypertension (approximately 85% of cases), 7% to 10% of patients with ascites develop secondary to a malignancy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ascites
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2017to Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients will be recruited from Departments of Internal Medicine, Assiut university tertiary hospital.
Who may be able to join
- Patients with ascites
- serum ascites albumin gradient >1.1.
Who cannot join
- ascitic fluid serum ascites albumin gradient <1.1.
- Haemorrgaic ascites;
- chylous ascites
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut Faculty of Medicine
Asyut
Ahmed Abbas, MD, 00201003385183, bmr90@hotmail.com
About this study
Official title: Evaluation of Different Etiologies of Obscure Ascites: Clinical, Laboratory, and Laparoscopic Study.
Ascites refers to fluid that accumulates within the peritoneal cavity. Although ascites is most commonly observed in patients with cirrhosis and resulting portal hypertension (approximately 85% of cases), 7% to 10% of patients with ascites develop secondary to a malignancy
- Conditions
- Ascites
- Medical subject headings
- Ascites
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with malignant ascites
according to laboratory and clinical criteria
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Aug 2017
- Primary completionAug 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AscitesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205748
- Sponsor's protocol ID
- OA
- Status last verified
- Nov 2017
- First submitted
- 29 Jun 2017
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Etiologies of Obscure Ascites: Clinical, Laboratory, and Laparoscopic Study.
- ClinicalTrials.gov ID
- NCT03205748
- Acronym / sponsor ID
- OA
- Conditions
- Ascites
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 2 Jul 2017 (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.
Ascites refers to fluid that accumulates within the peritoneal cavity. Although ascites is most commonly observed in patients with cirrhosis and resulting portal hypertension (approximately 85% of cases), 7% to 10% of patients with ascites develop secondary to a malignancy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients will be recruited from Departments of Internal Medicine, Assiut university tertiary hospital.
Key inclusion criteria (2 listed)
- Patients with ascites
- serum ascites albumin gradient >1.1.
Key exclusion criteria (3 listed)
- ascitic fluid serum ascites albumin gradient <1.1.
- Haemorrgaic ascites;
- chylous ascites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The percentage of patients with malignant ascites
Time frame: 1 month
according to laboratory and clinical criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
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Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites
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Ascites
Not yet recruitingObservational study
Development and Validation of a TIPS Prognostic Model
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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.
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 Ascites, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 3 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 29 Nov 2017. 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 Egypt. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients with malignant ascites (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2017.