PROSPECTIVE REGISTRY OF CANCER AND EVENTS INVOLVING VENOUS THROMBOEMBOLISM
INTRODUCTION TO PERCEIVE
Prospective Registry of Cancer and Events Involving Venous Thromboembolism.
Chief Investigator: Dr Gloria Petralia
Welcome to the PERCEIVE website, where you can access details on the study and its participating centres. You will find essential study information, newsletters and reports.
Core Team:
Clinical Trials Unit
Thrombosis Research Institute
Emmanuel Kaye Building
1b Manresa Road
Chelsea
London SW3 6LR
United Kingdom
E-mail: perceive@tri-london.ac.uk
About PERCEIVE
PERCEIVE is the largest worldwide cancer registry to prospectively record both venous and arterial blood clot complications and their treatment. With over 5,000 enrolled subjects, it has accrued up to 11 years of follow-up data.
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Overview
Overview
The Prospective Registry of Cancer and Events Involving Venous Thromboembolism (PERCEIVE) is a prospective, multicentre, international registry of patients with newly diagnosed cancer. PERCEIVE was designed to collect comprehensive data on blood clots risk, prevention and treatment, and how effective this is in real practice. This will help to deploy resources in an efficient and cost-effective way when treating these patients.
The clinical trials unit of the Thrombosis Research Institute launched the trial on 22nd February 2005 and the first patient was recruited on 1st April 2005.
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Clinical Need
Clinical Need
Venous thromboembolism (blood clots in the blood vessels) is estimated to be the second most common cause of death in cancer patients, with up to 60% of those deaths occurring at an otherwise favourable time in the history of the cancer. Prevention and treatment of blood clots increases the risk of bleeding, and unfortunately cancer patients are known to be more susceptible to bleeding complication either due to the cancer itself or its treatment. Better understanding of blood clot risk and treatment in patients with cancer will help to improve prevention and quality of life in these patients.
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Map
Map
Study Centres
Country Centre UTC Austria Allgemeines Krankenhaus der Stadt Wien +1 hour India Sir Ganga Ram Hospital +5.30 hours Italy Ospedali Riuniti di Bergamo +1 hour Italy University Hospital Messina +1 hour Singapore National University Hospital +8 hours UK 3 Counties Cancer Research Network +0 hour UK Barts and the London NHS Trust +0 hour UK Bronglais General Hospital +0 hour USA James P. Wilmot Cancer Center -5 hours The PERCEIVE community includes nine cancer centres at hospitals in six countries (Austria, India, Italy, Singapore, UK, USA) which recruited participants to the trial.
Study Details
This is a prospective, international, multicentre, registry to collect real-life comprehensive data on the oncology population and its relationship with VTE.
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Rationale
Rationale
Venous thromboembolism (VTE) is a serious and relatively common event in individuals with malignancy. Its occurrence complicates the clinical care of the patient and can have a profound negative impact on an already compromised quality of life. In one study it was estimated that one of seven cancer patients will die of potentially avoidable pulmonary embolism (PE) rather than cancer itself.
There is good evidence that postoperative thromboprophylaxis is effective and safe in cancer patients undergoing surgery. However, we have no data on how often such prophylaxis is used; which agents are used, e.g. unfractionated heparin, low-molecular-weight heparin (LMWH) or stockings; and the duration of prophylaxis.
Many cancer patients are admitted to hospital to deal with acute medical complications, e.g. hypercalcemia, febrile neutropenia, pain crises. It is unclear whether such patients receive thromboprophylaxis. Furthermore, it is unknown when cancer patients admitted for end-of-life care receive thromboprophylaxis.
Cancer patients receiving chemotherapy do not routinely receive antithrombotic prophylaxis unless they have a history of VTE. This is probably because there is a perception that the risk is low and prophylactic methods are logistically complicated. It may be possible, however to identify a group of cancer patients at very high risk of VTE (via risk stratification) for whom oncologists would agree that prophylaxis is warranted.
The Thrombosis Research Institute recognised the need for an international registry to provide real life, prospective, comprehensive data on cancer patients clinical journey and its relationship with VTE.
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Objectives & End Points
Objectives & End Points
Primary Objective
Aim: To collect data on the clinical incidence, treatment and outcome of thromboembolic events in patients with newly diagnosed malignancy.
Prospective collection of the data constitutes a scientifically sound base from which to evaluate standards of good medical practice, causes for underachievement and, ultimately, to improve patient care in the world arena.
- Pancreas
- Lung
- Prostate
- Breast
- Colon and rectum
- Ovary
Secondary Objectives
- To produce evidence to help set standards of practice to improve patients’ clinical care and expected outcome in terms of both prevention and treatment of thromboembolism.
- To provide data to aid in knowledge transfer for antithrombotic prevention and treatment in cancer patients.
- To identify areas of interest for future studies to investigate specific related issues.
- To ensure that the results are made available to the medical and scientific related issues.
- To ensure that the results are made available to the medical and scientific community by means of publications in peer-reviewed medical journals.
End Points
- Incidence of venous thromboembolism
- Incidence of stroke, myocardial infarction, peripheral arterial thrombosis
- Incidence of bleeding
- Survival
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Study Design
Study Design
Patients are to be treated according to local best practice. No additional tests or procedures are required by the registry. Selected data has been collected from that recorded in the patients’ clinical records according to the specification in the electronic Case Report Form (eCRF). Patient progress has been monitored, for a minimum of 10 years, or until death with special attention to medical history, thromboembolic risk factors and events, treatment and outcome.
Rationale for Study Design
This is a data registry and no treatment will be withheld or started for the purposes of the study. The main design features are:
- Multi-centre, international (the project will take place in North America, Europe and Asia): to be able to compare and contrast different management strategies.
- Prospective: to collect up-to-date information.
- Non-interventional i.e. a data registry: to collect real-life data.
- Patients will be followed to a minimum of 10 years, or until death to collect good outcome data.
Study Population
Consecutive patients with a newly diagnosed malignancy of the breast, colon and rectum, pancreas, lung, prostate or ovary to be considered for enrolment in order to collect a representative sample. Each recruited patient has to meet the study criteria and have given consent.
Inclusion Criteria
An answer of “no” to any of the following excludes the subject from entering the study.
- New histological diagnosis of one of the following and meeting the stage:
- Breast Cancer Stage IA or higher
- Colorectal Cancer Stage I or higher
- Pancreatic Cancer Stage IA or higher
- Ovarian Cancer Stage I or higher
- Lung cancer Stage IA or higher
- Prostate Cancer Stage II or higher
- Age over 18 years.
- Signed Informed Consent.
Exclusion Criteria
An answer of “yes” to the following excludes the subject from entering the study.
1. No further follow-up envisaged in the enrolment centre. -
Data Collection
Data Collection
Data Entry
Achieved via an electronic Case Report Form (eCRF) using a validated Electronic Data Capture (EDC) system.
Flow Chart
For Investigators
Recruitment has now been closed and data collection has now been completed. All data queries have been resolved and the database has been locked. It is being transferred to the study statistician for statistical analysis.
