Deep Vein ThrombosisNCT03909399
Prevention and Prophylaxis of Cancer Associated Thrombosis in High Risk Oncology Patients
An observational study of Deep Vein Thrombosis and Pulmonary Embolism, run by Hellenic Society of Medical Oncology at 1 site in Greece.
Trial summary
Prevention and Prophylaxis (Thromboprophylaxis - ACT) of Cancer Associated Thrombosis (CAT) in High Risk Oncology Patients: ACT4CAT. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deep Vein Thrombosis, Pulmonary Embolism, Vena Cava Thrombosis
- How many people
- 500 participants
- Where
- 1 siteGreece
- Study dates
- 25 Jan 2019to 31 Mar 2021
- 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: The objective of the "ACT4CAT" study is to collect real world data of daily clinical practice regarding thromboprophylaxis in high thrombotic risk ambulatory cancer patients. In particular, in this study we will collect data from patients with high thrombotic risk solid tumors (GI, thoracic, gynecologic, genitourinary or CNS) who receive or not anticancer treatment and have already administered thromboprophylaxis treatment according to the current clinical practice guidelines. Based on these real world data we will try to assess the efficacy and safety of long term VTE thromboprophylaxis in cancer patients.
Who may be able to join
- Patients who were diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic, genitourinary or CNS).
- Patients who have already started on thromboprophylaxis treatment according to the current clinical practice guidelines and the clinical judgment of treating physician after discussion with patient, within three months before the study enrollment.
- Age ≥ 18 years
- ECOG 0-2
- Life expectancy >6 months
- Signed informed consent
Who cannot join
- Patients who were not diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic, genitourinary or CNS).
- Patients who have not already started on thromboprophylaxis treatment according to the current clinical practice guidelines or who have already started on thromboprophylaxis but more than three months before the study enrollment.
- Age < 18 years
- ECOG >2
- Life expectancy <6 months
- Not signed informed consent
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Hellenic Society of Medical Oncology
Athens, 11475
Kalliopi Sarikaki, SC, +302106457971, psarikaki@hesmo.gr
About this study
Official title: Prevention and Prophylaxis (Thromboprophylaxis - ACT) of Cancer Associated Thrombosis (CAT) in High Risk Oncology Patients: ACT4CAT.
Prevention and Prophylaxis (Thromboprophylaxis - ACT) of Cancer Associated Thrombosis (CAT) in High Risk Oncology Patients: ACT4CAT.
Read the detailed description
Venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE), is a highly prevalent complication of malignancy. The development of VTE in cancer patients is associated with several adverse consequences including worsened short- and long-term prognosis and survival, mortality, morbidity, chemotherapy postponement, potential hospitalization, need for long-term anticoagulation with attendant bleeding complications and high rates of recurrent VTE . In addition, VTE leads to significant consumption of health care resources; in one study of cancer patients, the adjusted mean incremental all-cause health care costs of VTE were $30,538 per patient. Therefore, the optimal prevention and treatment of VTE are crucial components of patient care in this population. Currently, Low-Molecular-Weight Heparin (LMWH), is the gold standard for the CAT management for the last 15 years Moreover, in a variety of high-risk thrombosis clinical settings, LMWHs agents are safe and effective in preventing VTE. Multiple randomized trials of thromboprophylaxis have been conducted focusing on ambulatory cancer patients receiving chemotherapy. ESMO and ASCO current guidelines suggest considering thromboprophylaxis in high-risk ambulatory cancer patients with LMWHs. ECOG index, metastatic malignancy, chemotherapy and history of thrombosis were significantly associated with the decision to use thromboprophylaxis in most situations.
Additionally, in 2016 Hellenic Society of Medical Oncology (HeSMO) has conducted the GMaT study to assess the awareness of Thrombosis and highlight the current clinical practice in Greece. The study has precluded adoption of outpatient prophylaxis in largely unselected patients with cancer without significant adverse events. Based on GMaT findings, the investigators will proceed in an observational study focusing on thromboprophylaxis in cancer patients with high thrombotic cancer types. In particular, the title of this new study will be "Prevention and Prophylaxis (Thromboprophylaxis - ACT) of Cancer Associated Thrombosis (CAT) in High Risk Oncology Patients: ACT4CAT".
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism, Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Recording all objectively confirmed VTE events for 500 patients during the treatment period
Recording the rate of symptomatic distal deep vein thrombosis (DVT), symptomatic or incidental proximal DVT (including iliac and vena cava thrombosis), symptomatic or incidental pulmonary embolism (PE) or both DVT and P, will also be recorded the agent, the dose and the duration of the antithrombotic therapy
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 posted10 Apr 2019
- Study start25 Jan 2019
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Society of Medical Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909399
- Sponsor's protocol ID
- ACT4CAT
- Status last verified
- Jul 2020
- First submitted
- 4 Apr 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Prophylaxis (Thromboprophylaxis - ACT) of Cancer Associated Thrombosis (CAT) in High Risk Oncology Patients: ACT4CAT.
- ClinicalTrials.gov ID
- NCT03909399
- Acronym / sponsor ID
- ACT4CAT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hellenic Society of Medical OncologyUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 10 Apr 2019 (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.
Prevention and Prophylaxis (Thromboprophylaxis - ACT) of Cancer Associated Thrombosis (CAT) in High Risk Oncology Patients: ACT4CAT.
Detailed description
Venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE), is a highly prevalent complication of malignancy. The development of VTE in cancer patients is associated with several adverse consequences including worsened short- and long-term prognosis and survival, mortality, morbidity, chemotherapy postponement, potential hospitalization, need for long-term anticoagulation with attendant bleeding complications and high rates of recurrent VTE . In addition, VTE leads to significant consumption of health care resources; in one study of cancer patients, the adjusted mean incremental all-cause health care costs of VTE were $30,538 per patient. Therefore, the optimal prevention and treatment of VTE are crucial components of patient care in this population. Currently, Low-Molecular-Weight Heparin (LMWH), is the gold standard for the CAT management for the last 15 years Moreover, in a variety of high-risk thrombosis clinical settings, LMWHs agents are safe and effective in preventing VTE. Multiple randomized trials of thromboprophylaxis have been conducted focusing on ambulatory cancer patients receiving chemotherapy. ESMO and ASCO current guidelines suggest considering thromboprophylaxis in high-risk ambulatory cancer patients with LMWHs. ECOG index, metastatic malignancy, chemotherapy and history of thrombosis were significantly associated with the decision to use thromboprophylaxis in most situations.
Additionally, in 2016 Hellenic Society of Medical Oncology (HeSMO) has conducted the GMaT study to assess the awareness of Thrombosis and highlight the current clinical practice in Greece. The study has precluded adoption of outpatient prophylaxis in largely unselected patients with cancer without significant adverse events. Based on GMaT findings, the investigators will proceed in an observational study focusing on thromboprophylaxis in cancer patients with high thrombotic cancer types. In particular, the title of this new study will be "Prevention and Prophylaxis (Thromboprophylaxis - ACT) of Cancer Associated Thrombosis (CAT) in High Risk Oncology Patients: ACT4CAT".
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
- The objective of the "ACT4CAT" study is to collect real world data of daily clinical practice regarding thromboprophylaxis in high thrombotic risk ambulatory cancer patients. In particular, in this study we will collect data from patients with high thrombotic risk solid tumors (GI, thoracic, gynecologic, genitourinary or CNS) who receive or not anticancer treatment and have already administered thromboprophylaxis treatment according to the current clinical practice guidelines. Based on these real world data we will try to assess the efficacy and safety of long term VTE thromboprophylaxis in cancer patients.
Key inclusion criteria (6 listed)
- Patients who were diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic, genitourinary or CNS).
- Patients who have already started on thromboprophylaxis treatment according to the current clinical practice guidelines and the clinical judgment of treating physician after discussion with patient, within three months before the study enrollment.
- Age ≥ 18 years
- ECOG 0-2
- Life expectancy >6 months
Key exclusion criteria (6 listed)
- Patients who were not diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic, genitourinary or CNS).
- Patients who have not already started on thromboprophylaxis treatment according to the current clinical practice guidelines or who have already started on thromboprophylaxis but more than three months before the study enrollment.
- Age < 18 years
- ECOG >2
- Life expectancy <6 months
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
Recording all objectively confirmed VTE events for 500 patients during the treatment period
Time frame: 1 YEAR
Recording the rate of symptomatic distal deep vein thrombosis (DVT), symptomatic or incidental proximal DVT (including iliac and vena cava thrombosis), symptomatic or incidental pulmonary embolism (PE) or both DVT and P, will also be recorded the agent, the dose and the duration of the antithrombotic therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- 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.
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 Deep Vein Thrombosis and Pulmonary Embolism, run by Hellenic Society of Medical Oncology at 1 site in Greece.
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 6 inclusion and 6 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 10 Feb 2021. 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 Greece. 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 Nikolaos Tsoukalas, MD (+302107288598, tsoukn@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recording all objectively confirmed VTE events for 500 patients during the treatment period (time frame: 1 YEAR). 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 10 Feb 2021.