Venous ThromboembolismNCT04846556
Cancer Associated Thrombosis : What is the Proportion of Patients Ineligible to a Study as CARAVAGGIO
An observational study of Venous Thromboembolism and Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial summary
Venous thromboembolism is a common and fatal disease closely related to cancer. The therapeutic challenge is major due to the high risk of recurrent thromboembolism and bleeding in patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Cancer
- What is being tested?
- data collection
- How many people
- 300 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Apr 2022to 30 Jun 2022
- 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: Patients admitted for a venous thromboembolic event related to their cancer will be included between 2017 and 2019 at Saint-Etienne University Hospital, Louis-Mourier Hospital (AP-HP) and Amiens University Hospital.
Who may be able to join
- Consecutive patients with a newly diagnosed, objectively confirmed:
- symptomatic or unsuspected Deep Vein Thrombosis (DVT) (any location)
- symptomatic or unsuspected Pulmonary Embolism (PE)
- Consecutive patients with any type of cancer whose primary brain tumor or known intracerebral metastases and acute leukemia that meets at least one of the following:
- Active cancer defined as diagnosis of cancer within six months or receiving treatment for cancer or any treatment for cancer or recurrent locally advanced or metastatic cancer.
- Cancer diagnosed within 2 years.
Who cannot join
- pregnant women or breast feeding
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU d'Amiens
Amiens, 80000
Hôpital Louis Mourier
Colombes, 92000
Chu Saint-Etienne
Saint-Etienne
About this study
Official title: Cancer Associated Thrombosis: What is the Proportion of Patients Ineligible to a Study as CARAVAGGIO (a Retrospective Multicenter Study)
Venous thromboembolism is a common and fatal disease closely related to cancer. The therapeutic challenge is major due to the high risk of recurrent thromboembolism and bleeding in patients with cancer.
Guidelines recommend the use of low molecular-weight heparin for the treatment of Cancer-Associated venous Thromboembolism (CAT) at least for 3 to 6 months of treatment.
Read more
However, recent advances through the results of several therapeutic trials such as CARAVAGGIO (NCT03045406) open the door to the use of Direct Oral AntiCoagulants (DOACs) as first-line therapy.
Nevertheless, extrapolation of its results may be limited owing to a large number of inclusion and exclusion criteria, which may have selected a reduced population.
The proportion of patients admitted with acute CAT who may not eligible to a trial as CARAVAGGIO is unknown.
Read the detailed description
The aim of this study si to assess this proportion in a retrospective multicenter study, of patients admitted for acute Cancer-Associated venous Thromboembolism (CAT).
- Conditions
- Venous Thromboembolism, Cancer
- Being tested
- data collection
- Keywords
- Cancer, thrombosis, epidemiology, cancer-associated venous thromboembolism (CAT), venous thromboembolic event
- Medical subject headings
- Venous Thromboembolism, Neoplasms, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
data collection : gender, weight, biological data (platelets, hemoglobin, creatinine, liver function tests), performance status, type of Venous Thromboembolic Event (VTE) and cancer, anticancer and anticoagulant therapy, adverse events (bleeding, recurrence of Venous Thromboembolic Event (VTE), death) up to 6 months after their Venous Thromboembolic Event (VTE).
| Study group | Role | What they receive |
|---|---|---|
| venous thromboembolic event related to cancer | Patients admitted for a venous thromboembolic event related to their cancer will be included A data collection will be realized. Patients admitted between 2017 and 2019 at Saint-Etienne University Hospital, Louis-Mourier Hospital (AP-HP) and Amiens University Hospital. Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of cancer patients with a venous thromboembolic event (VTE) ineligible for CARAVAGGIO study
Patient having at least one of the following exclusion criteria (from CARAVAGGIO study) :
- ECOG (Eastern Cooperative Oncology Group ) Performance Status III or IV;
- life expectancy of less than 6 months;
- thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index episode;
- indication for anticoagulant treatment for a disease other than the index VTE episode;
- thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy;
- recent brain, spinal or ophthalmic surgery
- hemoglobin level lower than 8 g/dL or platelet count <75x10^9/L or history of heparin induced thrombocytopenia;
- creatinine clearance < 30 ml /min
- acute hepatitis, chronic active hepatitis, liver cirrhosis;
- uncontrolled hypertension;
- concomitant use of strong inhibitors or inducers of cytochrome;
- bacterial endocarditis;
Measured: Up to 6 months after venous thromboembolic event
Secondary outcomes (4)
Drugs used for their VTE
Collected in medical history.
Measured: Up to 6 months after venous thromboembolic event
Confirmed recurrent Venous Thromboembolic Event (VTE)
Collected in medical history.
- Pulmonary embolism
- deep venous thrombosis
Measured: Up to 6 months after venous thromboembolic event
Bleeding event
Collected in medical history.
Measured: Up to 6 months after venous thromboembolic event
Death
Collected in medical history.
Measured: Up to 6 months after venous thromboembolic event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Apr 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Bertoletti, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846556
- Sponsor's protocol ID
- IRBN352021/CHUSTE
- Status last verified
- Oct 2023
- First submitted
- 13 Apr 2021
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Associated Thrombosis: What is the Proportion of Patients Ineligible to a Study as CARAVAGGIO (a Retrospective Multicenter Study)
- ClinicalTrials.gov ID
- NCT04846556
- Acronym / sponsor ID
- IRBN352021/CHUSTE
- Conditions
- Venous Thromboembolism, Cancer
- Keywords
- Cancer, thrombosis, epidemiology, cancer-associated venous thromboembolism (CAT), venous thromboembolic event
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 15 Apr 2021 (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.
Venous thromboembolism is a common and fatal disease closely related to cancer. The therapeutic challenge is major due to the high risk of recurrent thromboembolism and bleeding in patients with cancer.
Guidelines recommend the use of low molecular-weight heparin for the treatment of Cancer-Associated venous Thromboembolism (CAT) at least for 3 to 6 months of treatment.
However, recent advances through the results of several therapeutic trials such as CARAVAGGIO (NCT03045406) open the door to the use of Direct Oral AntiCoagulants (DOACs) as first-line therapy.
Nevertheless, extrapolation of its results may be limited owing to a large number of inclusion and exclusion criteria, which may have selected a reduced population.
The proportion of patients admitted with acute CAT who may not eligible to a trial as CARAVAGGIO is unknown.
Detailed description
The aim of this study si to assess this proportion in a retrospective multicenter study, of patients admitted for acute Cancer-Associated venous Thromboembolism (CAT).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| venous thromboembolic event related to cancer | – | Other: data collectionPatients admitted for a venous thromboembolic event related to their cancer will be included A data collection will be realized. Patients admitted between 2017 and 2019 at Saint-Etienne University Hospital, Louis-Mourier Hospital (AP-HP) and Amiens University Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted for a venous thromboembolic event related to their cancer will be included between 2017 and 2019 at Saint-Etienne University Hospital, Louis-Mourier Hospital (AP-HP) and Amiens University Hospital.
Key inclusion criteria (6 listed)
- symptomatic or unsuspected Deep Vein Thrombosis (DVT) (any location)
- symptomatic or unsuspected Pulmonary Embolism (PE)
- Consecutive patients with any type of cancer whose primary brain tumor or known intracerebral metastases and acute leukemia that meets at least one of the following:
- Active cancer defined as diagnosis of cancer within six months or receiving treatment for cancer or any treatment for cancer or recurrent locally advanced or metastatic cancer.
- Cancer diagnosed within 2 years.
Key exclusion criteria (1 listed)
- pregnant women or breast feeding
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 |
|---|---|---|
| data collectiondata collection : gender, weight, biological data (platelets, hemoglobin, creatinine, liver function tests), performance status, type of Venous Thromboembolic Event (VTE) and cancer, anticancer and anticoagulant therapy, adverse events (bleeding, recurrence of Venous Thromboembolic Event (VTE), death) up to 6 months after their Venous Thromboembolic Event (VTE). | Other | venous thromboembolic event related to cancer |
Primary outcome
Proportion of cancer patients with a venous thromboembolic event (VTE) ineligible for CARAVAGGIO study
Time frame: Up to 6 months after venous thromboembolic event
Patient having at least one of the following exclusion criteria (from CARAVAGGIO study) : * ECOG (Eastern Cooperative Oncology Group ) Performance Status III or IV; * life expectancy of less than 6 months; * thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index episode; * indication for anticoagulant treatment for a disease other than the index VTE episode; * thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy; * recent brain, spinal or ophthalmic surgery * hemoglobin level lower than 8 g/dL or platelet count <75x10^9/L or history of heparin induced thrombocytopenia; * creatinine clearance < 30 ml /min * acute hepatitis, chronic active hepatitis, liver cirrhosis; * uncontrolled hypertension; * concomitant use of strong inhibitors or inducers of cytochrome; * bacterial endocarditis;
4 secondary outcomes
Drugs used for their VTE
Time frame: Up to 6 months after venous thromboembolic event
Confirmed recurrent Venous Thromboembolic Event (VTE)
Time frame: Up to 6 months after venous thromboembolic event
Bleeding event
Time frame: Up to 6 months after venous thromboembolic event
Death
Time frame: Up to 6 months after venous thromboembolic event
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 11 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Laurent Bertoletti, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites 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 6 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 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Proportion of cancer patients with a venous thromboembolic event (VTE) ineligible for CARAVAGGIO study (time frame: Up to 6 months after venous thromboembolic event). 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 11 Oct 2023.