Refractory Malignant AscitesBEVASCITENCT02891369
Analysis of Patients Treated With Bevacizumab Intraperitoneal for the Treatment of Refractory Malignant Ascites
An observational study of Refractory Malignant Ascites, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The refractory malignant ascites is a complication of advanced stages of many cancer types. It is characterized clinically by abdominal pressure sensation, shortness of breath and pelvic pain. Thus, it contributes to decreased quality of life for these patients in palliative care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Refractory Malignant Ascites
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to May 2015
- 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: Patients admitted with Refractory Malignant Ascites and wgho received bevacizumab intraperitoneal (IP) injection
Who may be able to join
- All assigns patients received at least one injection of bevacizumab intraperitoneal within GHPSJ between 01/01/2007 and 31/12/2014
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: Retrospective Analysis of Patients Treated With Bevacizumab in GHPSJ Intraperitoneal for the Treatment of Refractory Malignant Ascites
The refractory malignant ascites is a complication of advanced stages of many cancer types. It is characterized clinically by abdominal pressure sensation, shortness of breath and pelvic pain. Thus, it contributes to decreased quality of life for these patients in palliative care.
Conventional treatment is based on paracentesis of ascites. The progression of the disease leads to increased production of ascites requiring more frequent paracentesis. Main therapeutic alternatives are constituted by the controversial use of diuretics and the use of an antibody inhibiting the activity of the Vascular Endothelial Growth Factor (VEGF): bevacizumab. Catumaxomab, a monoclonal antibody anti-EpCAM and CD3, developed for the treatment of refractory malignant ascites showed no sufficient clinical benefit.
Read more
VEGF is overexpressed in many tumors. VEGF causes an increase in capillary permeability and capillary filtration surface generating increased protein extravasation. These phenomena are responsible for an increase of the volume of ascites product. Thus the use of inhibitors of VEGF, such as bevacizumab, could reduce the production of ascites.
The efficacy of bevacizumab to decrease the volume of ascites product was demonstrated on small animals in intraperitoneal administration.
Studies in humans are few and the doses used are not consistent from one study to another.
Read the detailed description
Main objective / secondary:
The objective of this study is to describe the population, adverse effects, the volume of ascites product and time between paracentesis in patients receiving bevacizumab in intraperitoneal through a refractory malignant ascites.
Methodology :
This is a retrospective study mono centric and non-interventional. data collected
- Name,
- date of birth,
- dates and numbers injection of bevacizumab doses
- side effects,
- type of cancer, TNM classification,
- ascites volume collected during paracentesis prior to the introduction of IP bevacizumab,
- frequency of paracentesis before the introduction of IP bevacizumab,
- ascites volume collected during paracentesis after the introduction of IP bevacizumab,
- frequency after paracentesis after the introduction of IP bevacizumab,
- albumin
- Number of lines of chemotherapy received
- Treatment monotherapy or in combination with other chemotherapies
- WHO Stadium in each course
- Date of death supports
- Data collection from CHIMIO® software DxCare® and non-computerized patient records.
- Series anonymized patient data on Excel®
Circulation mode and data processing and not opposition patient The anonymous data are entered on a computer file and centralized within the pharmacy department by the investigator of the Groupe Hospitalier Saint Joseph Paris, Carole METZ, to be processed locally.
For the statistical analysis, quantitative variables are expressed by their mean, standard deviations, their minimum and maximum values as appropriate. The variables will be expressed in numbers and percentages. Descriptive data analyzes, correlations between the study variables and more specific tests to determine the prognostic value of variable can be used.
This is a single-center retrospective cohort within the GHPSJ. Patients are aware of the potential use of their data in their files for medical research by information contained in the handbook of the institution for patients.
Development of the study:
- The list of patients who received bevacizumab injection is obtained from the CHIMIO® software.
- The data collected is validated by a multidisciplinary way oncologists and pharmacists.
- Collection and analysis of data by the internal pharmacy from computerized patient records (DxCare®) or not computerized.
- Conditions
- Refractory Malignant Ascites
- Being tested
- No intervention. Descriptive study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. Descriptive studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the ascites volume
Assessment of the ascites volume (mL) collected during paracentesis prior to the introduction of IP bevacizumab
Measured: 1 Hour before introduction of bevacizumab
Secondary outcomes (2)
Assessment of the TNM classification of the cancer
type of cancer, TNM
Measured: Day1
Assessment of the number of paracentis happened
frequency after paracentesis after the introduction of IP bevacizumab
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startFeb 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Malignant AscitesStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meryam JARDIN, PharmD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891369
- Sponsor's protocol ID
- BEVASCITE
- Acronym
- BEVASCITE
- Status last verified
- Sep 2016
- First submitted
- 1 Sep 2016
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Patients Treated With Bevacizumab in GHPSJ Intraperitoneal for the Treatment of Refractory Malignant Ascites
- ClinicalTrials.gov ID
- NCT02891369
- Acronym / sponsor ID
- BEVASCITE / BEVASCITE
- Conditions
- Refractory Malignant Ascites
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 Sep 2016 (estimated)
- 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.
The refractory malignant ascites is a complication of advanced stages of many cancer types. It is characterized clinically by abdominal pressure sensation, shortness of breath and pelvic pain. Thus, it contributes to decreased quality of life for these patients in palliative care.
Conventional treatment is based on paracentesis of ascites. The progression of the disease leads to increased production of ascites requiring more frequent paracentesis. Main therapeutic alternatives are constituted by the controversial use of diuretics and the use of an antibody inhibiting the activity of the Vascular Endothelial Growth Factor (VEGF): bevacizumab. Catumaxomab, a monoclonal antibody anti-EpCAM and CD3, developed for the treatment of refractory malignant ascites showed no sufficient clinical benefit.
VEGF is overexpressed in many tumors. VEGF causes an increase in capillary permeability and capillary filtration surface generating increased protein extravasation. These phenomena are responsible for an increase of the volume of ascites product. Thus the use of inhibitors of VEGF, such as bevacizumab, could reduce the production of ascites.
The efficacy of bevacizumab to decrease the volume of ascites product was demonstrated on small animals in intraperitoneal administration.
Studies in humans are few and the doses used are not consistent from one study to another.
Detailed description
Main objective / secondary:
The objective of this study is to describe the population, adverse effects, the volume of ascites product and time between paracentesis in patients receiving bevacizumab in intraperitoneal through a refractory malignant ascites.
Methodology :
This is a retrospective study mono centric and non-interventional. data collected
- Name,
- date of birth,
- dates and numbers injection of bevacizumab doses
- side effects,
- type of cancer, TNM classification,
- ascites volume collected during paracentesis prior to the introduction of IP bevacizumab,
- frequency of paracentesis before the introduction of IP bevacizumab,
- ascites volume collected during paracentesis after the introduction of IP bevacizumab,
- frequency after paracentesis after the introduction of IP bevacizumab,
- albumin
- Number of lines of chemotherapy received
- Treatment monotherapy or in combination with other chemotherapies
- WHO Stadium in each course
- Date of death supports
- Data collection from CHIMIO® software DxCare® and non-computerized patient records.
- Series anonymized patient data on Excel®
Circulation mode and data processing and not opposition patient The anonymous data are entered on a computer file and centralized within the pharmacy department by the investigator of the Groupe Hospitalier Saint Joseph Paris, Carole METZ, to be processed locally.
For the statistical analysis, quantitative variables are expressed by their mean, standard deviations, their minimum and maximum values as appropriate. The variables will be expressed in numbers and percentages. Descriptive data analyzes, correlations between the study variables and more specific tests to determine the prognostic value of variable can be used.
This is a single-center retrospective cohort within the GHPSJ. Patients are aware of the potential use of their data in their files for medical research by information contained in the handbook of the institution for patients.
Development of the study:
- The list of patients who received bevacizumab injection is obtained from the CHIMIO® software.
- The data collected is validated by a multidisciplinary way oncologists and pharmacists.
- Collection and analysis of data by the internal pharmacy from computerized patient records (DxCare®) or not computerized.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted with Refractory Malignant Ascites and wgho received bevacizumab intraperitoneal (IP) injection
Key inclusion criteria (1 listed)
- All assigns patients received at least one injection of bevacizumab intraperitoneal within GHPSJ between 01/01/2007 and 31/12/2014
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| No intervention. Descriptive study | Other | – |
Primary outcome
Assessment of the ascites volume
Time frame: 1 Hour before introduction of bevacizumab
Assessment of the ascites volume (mL) collected during paracentesis prior to the introduction of IP bevacizumab
2 secondary outcomes
Assessment of the TNM classification of the cancer
Time frame: Day1
Assessment of the number of paracentis happened
Time frame: Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Meryam JARDIN, PharmD principal investigator
Fondation Hôpital Saint-Joseph
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 Refractory Malignant Ascites, run by Fondation Hôpital Saint-Joseph 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 1 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: finished, as of the sponsor's last update on 14 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the ascites volume (time frame: 1 Hour before introduction of bevacizumab). 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 14 Aug 2018.