Upper Gastrointestinal BleedingNCT02508883
Evaluation of Prognostic Scores in Patients With Upper Gastrointestinal Bleeding and Cancer
An observational study of Upper Gastrointestinal Bleeding, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
This is a prospective and observational study to evaluate oncologic patients that presented upper gastrointestinal bleeding with the use of some prognostic scores. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- How many people
- 243 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2015to Jun 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients referred to the Endoscopy Unit of ICESP because of upper gastrointestinal bleeding will be included consecutively, according to the selection criteria mentioned below. The analysis of our recent data base allows us to estimate an accrual of about 300 patients at the end of 1 year of study.
Who may be able to join
- Confirmed diagnosis of malignant neoplasm of any site, either located inside or outside of GI tract;
- Current evidence of bleeding in the last 48 hours, either by presenting hematemesis and/or melena, with or without hemodynamic instability. Patients with hematochezia or bright red blood per rectum due to a site of bleeding in upper GI tract will also be included.
Who cannot join
- Age < 18 years-old;
- Suspicion or confirmation of pregnancy.
- Patients with no evidence of malignant neoplasm after curative surgery or oncologic therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Among the Scores of Glasgow-Blacthford, Rockall and AIMS65 for the Prediction of Rebleeding and Mortality in Patients With Cancer and Upper Gastrointestinal Bleeding
This is a prospective and observational study to evaluate oncologic patients that presented upper gastrointestinal bleeding with the use of some prognostic scores.
Read the detailed description
Background: Cancer incidence is rising worldwide, therefore complications of this condition, such as bleeding, are also expected to be more frequently seen.
Tumoral bleeding is usually difficult to control and the bleeding episode may represent the end stage of the malignant disease. In this context, it is relevant to study the performance of prognostic scores to prediction of clinical outcomes in patients with cancer.
Objective: To evaluate and compare the performance of prognostic scores to predict clinical outcomes in a group of patients with cancer of any site that has presented a recent episode of upper gastrointestinal bleeding (UGIB).
Design: Prospective and observational study. Setting: Cancer Institute of São Paulo; University of são Paulo. Patients: All patients with cancer referred to the Endoscopy Unit because of upper gastrointestinal bleeding will be included consecutively.
Main Outcome Measurements: need and amount of blood transfusions administered, need for endoscopic therapy, surgery, rebleeding, and mortality at 30 days.
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- Cancer, hemorrhage, endoscopy, gastrointestinal hemorrhage
- Medical subject headings
- Gastrointestinal Hemorrhage, Neoplasms, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Upper gastrointestinal bleeding | patients with cancer who presented or were admitted in the emergency room, wards or intensive care units of the Cancer Institute of São Paulo (ICESP), with a recent episode of upper gastrointestinal bleeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood transfusions administered
The need and amount of blood transfusions administered
Measured: 30 days
Endoscopic therapy
Hemostatic endoscopic therapy will be performed if there are findings of active or recent bleeding, under conscious or deep sedation after hemodynamic stabilization and oral fasting
Measured: 30 days
Surgery
need for surgery to control tumour bleeding
Measured: participants will be followed for the duration of hospital stay, an expected average of 30 days
rebleeding
episodes of rebleeding
Measured: 30 days
mortality
mortality
Measured: 30 days
Secondary outcomes (1)
Finding the cut-off value of highest sensitivity and specificity of Rockall, Glasgow-Blatchford and AIMS65 scores employing the receiver operating curve (ROC).
find the cut-off value of highest sensitivity and specificity of Rockall, Glasgow-Blatchford and AIMS65 scores for discriminant selection of a low-risk group, if one exists, among patients with recent upper gastrointestinal bleeding and cancer with confirmed diagnosis, located inside or outside the GI tract, who could be managed on an outpatient basis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal BleedingStudies 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
- Prospective
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fauze Maluf-Filho, MD, PHD, Principal investigator, Cancer Institute of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508883
- Sponsor's protocol ID
- NP621/14
- Status last verified
- Oct 2016
- First submitted
- 29 May 2015
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Among the Scores of Glasgow-Blacthford, Rockall and AIMS65 for the Prediction of Rebleeding and Mortality in Patients With Cancer and Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT02508883
- Acronym / sponsor ID
- NP621/14
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- Cancer, hemorrhage, endoscopy, gastrointestinal hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Jul 2015 (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.
This is a prospective and observational study to evaluate oncologic patients that presented upper gastrointestinal bleeding with the use of some prognostic scores.
Detailed description
Background: Cancer incidence is rising worldwide, therefore complications of this condition, such as bleeding, are also expected to be more frequently seen.
Tumoral bleeding is usually difficult to control and the bleeding episode may represent the end stage of the malignant disease. In this context, it is relevant to study the performance of prognostic scores to prediction of clinical outcomes in patients with cancer.
Objective: To evaluate and compare the performance of prognostic scores to predict clinical outcomes in a group of patients with cancer of any site that has presented a recent episode of upper gastrointestinal bleeding (UGIB).
Design: Prospective and observational study. Setting: Cancer Institute of São Paulo; University of são Paulo. Patients: All patients with cancer referred to the Endoscopy Unit because of upper gastrointestinal bleeding will be included consecutively.
Main Outcome Measurements: need and amount of blood transfusions administered, need for endoscopic therapy, surgery, rebleeding, and mortality at 30 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upper gastrointestinal bleeding | – | –patients with cancer who presented or were admitted in the emergency room, wards or intensive care units of the Cancer Institute of São Paulo (ICESP), with a recent episode of upper gastrointestinal bleeding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred to the Endoscopy Unit of ICESP because of upper gastrointestinal bleeding will be included consecutively, according to the selection criteria mentioned below. The analysis of our recent data base allows us to estimate an accrual of about 300 patients at the end of 1 year of study.
Key inclusion criteria (2 listed)
- Confirmed diagnosis of malignant neoplasm of any site, either located inside or outside of GI tract;
- Current evidence of bleeding in the last 48 hours, either by presenting hematemesis and/or melena, with or without hemodynamic instability. Patients with hematochezia or bright red blood per rectum due to a site of bleeding in upper GI tract will also be included.
Key exclusion criteria (3 listed)
- Age < 18 years-old;
- Suspicion or confirmation of pregnancy.
- Patients with no evidence of malignant neoplasm after curative surgery or oncologic therapy.
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
blood transfusions administered
Time frame: 30 days
The need and amount of blood transfusions administered
Endoscopic therapy
Time frame: 30 days
Hemostatic endoscopic therapy will be performed if there are findings of active or recent bleeding, under conscious or deep sedation after hemodynamic stabilization and oral fasting
Surgery
Time frame: participants will be followed for the duration of hospital stay, an expected average of 30 days
need for surgery to control tumour bleeding
rebleeding
Time frame: 30 days
episodes of rebleeding
mortality
Time frame: 30 days
mortality
1 secondary outcome
Finding the cut-off value of highest sensitivity and specificity of Rockall, Glasgow-Blatchford and AIMS65 scores employing the receiver operating curve (ROC).
Time frame: 1 year
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 6 Oct 2016.
Related trials for Upper Gastrointestinal Bleeding
Recruiting
OTSC vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding
Upper Gastrointestinal Bleeding
Recruiting
Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy
Acute Coronary Syndromes (ACS), Coronary Artery Disease (CAD)
Not yet recruitingPhase 3
Zastaprazan for the prEvention of Upper GI Bleeding in Ischemic Stroke
Ischemic Stroke, Transient Ischemic Attack
Recruiting
Detection of Blood in the GI Lumen With HemoPill Acute
Upper GI Bleeding
Active, not recruitingObservational study
Impact of Diagnostic and Therapeutic Upper and Lower Gastrointestinal Endoscopic Management on Critically Ill Patients in Fayoum University Hospitals
GIT Bleeding
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.
Fauze Maluf-Filho, MD, PHD principal investigator
Cancer Institute of São Paulo
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 Upper Gastrointestinal Bleeding, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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: finished, as of the sponsor's last update on 6 Oct 2016. 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 Brazil. 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?
blood transfusions administered (time frame: 30 days). The study lists 5 primary outcomes in all. 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 6 Oct 2016.