Metastatic Bronchopulmonary CancerLUCAATNCT04196790
Development of a Model to Predict the Risk of Venous Thromboembolic Events in Patients With Metastatic Bronchopulmonary Cancer
An observational study of Metastatic Bronchopulmonary Cancer, run by University Hospital, Brest at 3 sites in France.
Trial summary
Venous thrombo-embolism (VTE) is a frequent and serious complication of cancer. However, predictive tools for VTE in cancer patients is lacking. In patients with metastatic broncho-pulmonarycancer, biochemical characteristics might help to identify patients at high risk for VTE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Bronchopulmonary Cancer
- How many people
- 500 participants
- Where
- 3 sitesFrance
- Study dates
- 18 Dec 2019to 18 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 500 metastatic cancer patients prospectively recruited in this prospective cohort.
Who may be able to join
- metastatic broncho-pulmonary cancer
- age ≥18 years
- who are eligible for chemotherapy
- non opposition obtained
Who cannot join
- age <18 years
- pregnancy, breast feeding
- VTE in the past 6 months or at the time of cancer diagnosis
- surgery in the past 3 months
- refusal to participate
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Francis COUTURAUD, francis.couturaud@chu-brest.fr
- Not yet recruiting
CH des Pays de Morlaix
Morlaix, 29600
Christophe ROGE, croge@ch-morlaix.fr
- Not yet recruiting
CHIC de QUIMPER
Quimper, 29000
Florence VERGNE, florence.vergne@ch-cornouaille.fr
About this study
Official title: Développement d'un modèle prédictif du Risque de Survenue d'évènements Thromboemboliques Veineux Chez Les Patients Atteints de Cancer Broncho-pulmonaire métastatique
Venous thrombo-embolism (VTE) is a frequent and serious complication of cancer. However, predictive tools for VTE in cancer patients is lacking.
In patients with metastatic broncho-pulmonarycancer, biochemical characteristics might help to identify patients at high risk for VTE.
The aim of this study is to derive a predictive score combining clinical and biochemical variable that predict VTE in metastatic broncho-pulmonary cancer.
Read the detailed description
Venous thrombo-embolism (VTE) is a frequent and serious complication of cancer. However, predictive tools for VTE in cancer patients is lacking.
In patients with metastatic broncho-pulmonarycancer, biochemical characteristics might help to identify patients at high risk for VTE, particularly in adenocarcinoma.
The aim of this study is to derive a predictive score combining clinical and biochemical variable that predict VTE in metastatic broncho-pulmonary cancer.
- Conditions
- Metastatic Bronchopulmonary Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
venous thromboembolism at 12 months
objectively diagnosed VTE based on validated diagnostic tests
Measured: 12 months
Secondary outcomes (3)
overall survival
overall survival
Measured: one year
survival without progression
survival without progression
Measured: one year
VTE at 6 months
VTE at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start18 Dec 2019
- Primary completion18 Dec 2021 (estimated)
- Study completion18 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Bronchopulmonary CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196790
- Sponsor's protocol ID
- LUCAAT ( 29BRC19. 0224)
- Acronym
- LUCAAT
- Status last verified
- Dec 2019
- First submitted
- 8 Dec 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Développement d'un modèle prédictif du Risque de Survenue d'évènements Thromboemboliques Veineux Chez Les Patients Atteints de Cancer Broncho-pulmonaire métastatique
- ClinicalTrials.gov ID
- NCT04196790
- Acronym / sponsor ID
- LUCAAT / LUCAAT ( 29BRC19. 0224)
- Conditions
- Metastatic Bronchopulmonary Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 18 Dec 2021 (estimated)
- Study completion
- 18 Dec 2021 (estimated)
- First posted
- 12 Dec 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.
Venous thrombo-embolism (VTE) is a frequent and serious complication of cancer. However, predictive tools for VTE in cancer patients is lacking.
In patients with metastatic broncho-pulmonarycancer, biochemical characteristics might help to identify patients at high risk for VTE.
The aim of this study is to derive a predictive score combining clinical and biochemical variable that predict VTE in metastatic broncho-pulmonary cancer.
Detailed description
Venous thrombo-embolism (VTE) is a frequent and serious complication of cancer. However, predictive tools for VTE in cancer patients is lacking.
In patients with metastatic broncho-pulmonarycancer, biochemical characteristics might help to identify patients at high risk for VTE, particularly in adenocarcinoma.
The aim of this study is to derive a predictive score combining clinical and biochemical variable that predict VTE in metastatic broncho-pulmonary cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 500 metastatic cancer patients prospectively recruited in this prospective cohort.
Key inclusion criteria (4 listed)
- metastatic broncho-pulmonary cancer
- age ≥18 years
- who are eligible for chemotherapy
- non opposition obtained
Key exclusion criteria (5 listed)
- age <18 years
- pregnancy, breast feeding
- VTE in the past 6 months or at the time of cancer diagnosis
- surgery in the past 3 months
- refusal to participate
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
venous thromboembolism at 12 months
Time frame: 12 months
objectively diagnosed VTE based on validated diagnostic tests
3 secondary outcomes
overall survival
Time frame: one year
survival without progression
Time frame: one year
VTE at 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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.
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 Metastatic Bronchopulmonary Cancer, run by University Hospital, Brest 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 4 inclusion and 5 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 20 Dec 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francis COUTURAUD (02-98-34-78-26, francis.couturuad@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
venous thromboembolism at 12 months (time frame: 12 months). 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 20 Dec 2019.