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Screening for Cancer in Patients With Thromboembolic Disease (PEETAC)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Venous Thromboembolic Disease Respiratory Disease Pulmonary Disease Deep Venous Thrombosis Pulmonary Embolism | Drug: Fludeoxyglucose 18F | Phase 2 |
Venous thromboembolic disease (VTD) is an entity constituted by deep vein thrombosis (DVT) and by pulmonary embolism (PE) produced as a result of the migration of a thrombus from the venous territory, usually originated in the lower limbs, to the tree pulmonary artery. VTE is a complex disease with a multifactorial cause, influenced by the patient's history, clinical risk factors, and genetic and environmental interactions.
There is a clearly established relationship between VTD and the presence of an underlying cancer. In addition, ETV can be the first manifestation of cancer in some patients.
Therefore, the objective of this clinical trial is to perform screening with 18DFG PET-CT in patients with unprovoked high-risk VTD to evaluate if it is possible to diagnose a great number of not diagnosed neoplasms at an earlier stage and to evaluate which impact would have on survival and the quality of life.
For all this, we propose this clinical trial in which we will compare a limited screening strategy (usual management of patients with unprovoked VTE) versus extended screening (through 18FDG PET-CT), in patients at high risk of developing cancer in the follow-up.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 650 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Screening for Cancer With PET /TC Scan in Patients With Unprovoked Venous Thromboembolic Disease With High Risk of Developing Cancer. (PEETAC) |
| Estimated Study Start Date : | June 1, 2019 |
| Estimated Primary Completion Date : | June 1, 2021 |
| Estimated Study Completion Date : | December 1, 2021 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Limited screening
Complete clinical history, along with routine physical, analytical examination (creatinine, sodium, potassium, red series, white series, liver and calcium profile) and chest x-ray.
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Experimental: Extended screening
Limited screening plus positron emission tomography / computed tomography with 18 FDG (18FDG PET-CT).
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Drug: Fludeoxyglucose 18F
The performance of the 18 FDG PET-CT will require fasting of at least 6 hours, and the glycemia will have to be lower than 126 mg / dL before the injection of 3-5 MBq / kg of 18FDG. Intravenous injection will follow a period of approximately 60 minutes in a quiet room. Computed tomography (CT) will be performed from the middle of the forehead to the feet with normal and shallow breathing using a low dose adjustment Iodinated contrast will not be administered intravenously. |
- Number of neoplasms diagnosed using extended screening [ Time Frame: After 3 years of follow-up ]Estimate the impact of an active cancer search strategy using PET-CT in the number of neoplasms diagnosed in the screening process in patients with high-risk unprovoked thromboembolic disease.
- Number of neoplasms diagnosed in early phase using extended screening [ Time Frame: After 3 years of follow-up ]Estimate the impact of an active cancer search strategy using PET-CT in the number of neoplasms diagnosed in early phase in the screening process in patients with high-risk unprovoked thromboembolic disease.
- Overall survival of patients with high-risk unprovoked thromboembolic disease performing limited/extended screening [ Time Frame: Until the patient death or finalization of study after three years of follow-up ]Estimate the impact of an active cancer search strategy using PET-CT in the overall survival in patients with high-risk unprovoked thromboembolic disease.
- European Quality of Life-5 (EQ-5D scale validated in Spanish) of patients with high-risk unprovoked thromboembolic disease performing limited/extended screening [ Time Frame: Baseline and after 90, 180 and 365 days of follow-up ]
Estimate the impact of an active cancer search strategy using PET-CT in the quality of life evaluated with the scale EQ-5D in patients with high-risk unprovoked thromboembolic disease. The EQ-5D consists of 2 parts - the "Descriptive System" and the "Visual Analogue scale". The DS comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. This information can be used as a quantitative measure of health as judged by the individual respondents.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Over 18 years.
- Diagnosis of venous thromboembolic disease (proximal deep vein thrombosis of lower limbs, pulmonary embolism or both) unprovoked.
- High risk classification according to previously published and validated scale
- Signature of informed consent form
Exclusion Criteria:
- Impossibility to continue an adequate follow-up.
- Contrast hypersensitivity used for PET / CT (fludeoxyglucose (18FDG)) or any of the excipients according to the characteristics of the product.
| Contact: Luis Jara Palomares, MD/PhD | +34 955012144 | luisoneumo@hotmail.com | |
| Contact: Clara M Rosso Fernández, MD/PhD | +34955012144 | claram.rosso.sspa@juntadeandalucia.es |
| Principal Investigator: | Luis Jara Palomares, MD/PhD | Hospitales Universitarios Virgen del Rocío |
| Tracking Information | |||||||||||||
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| First Submitted Date ICMJE | April 30, 2019 | ||||||||||||
| First Posted Date ICMJE | May 6, 2019 | ||||||||||||
| Last Update Posted Date | May 7, 2019 | ||||||||||||
| Estimated Study Start Date ICMJE | June 1, 2019 | ||||||||||||
| Estimated Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Number of neoplasms diagnosed using extended screening [ Time Frame: After 3 years of follow-up ] Estimate the impact of an active cancer search strategy using PET-CT in the number of neoplasms diagnosed in the screening process in patients with high-risk unprovoked thromboembolic disease.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | |||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Screening for Cancer in Patients With Thromboembolic Disease | ||||||||||||
| Official Title ICMJE | Screening for Cancer With PET /TC Scan in Patients With Unprovoked Venous Thromboembolic Disease With High Risk of Developing Cancer. (PEETAC) | ||||||||||||
| Brief Summary | Multicenter, randomized (1:1) and open clinical trial comparing limited screening with extended screening with the performance of PET-CT (Positron emission tomography-computed tomography) in the search for neoplasms in patients with unprovoked venous thromboembolic disease at high risk of developing cancer at follow-up. | ||||||||||||
| Detailed Description |
Venous thromboembolic disease (VTD) is an entity constituted by deep vein thrombosis (DVT) and by pulmonary embolism (PE) produced as a result of the migration of a thrombus from the venous territory, usually originated in the lower limbs, to the tree pulmonary artery. VTE is a complex disease with a multifactorial cause, influenced by the patient's history, clinical risk factors, and genetic and environmental interactions. There is a clearly established relationship between VTD and the presence of an underlying cancer. In addition, ETV can be the first manifestation of cancer in some patients. Therefore, the objective of this clinical trial is to perform screening with 18DFG PET-CT in patients with unprovoked high-risk VTD to evaluate if it is possible to diagnose a great number of not diagnosed neoplasms at an earlier stage and to evaluate which impact would have on survival and the quality of life. For all this, we propose this clinical trial in which we will compare a limited screening strategy (usual management of patients with unprovoked VTE) versus extended screening (through 18FDG PET-CT), in patients at high risk of developing cancer in the follow-up. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase ICMJE | Phase 2 | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Fludeoxyglucose 18F
The performance of the 18 FDG PET-CT will require fasting of at least 6 hours, and the glycemia will have to be lower than 126 mg / dL before the injection of 3-5 MBq / kg of 18FDG. Intravenous injection will follow a period of approximately 60 minutes in a quiet room. Computed tomography (CT) will be performed from the middle of the forehead to the feet with normal and shallow breathing using a low dose adjustment Iodinated contrast will not be administered intravenously. |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||||||
| Estimated Enrollment ICMJE |
650 | ||||||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||||||
| Estimated Study Completion Date ICMJE | December 1, 2021 | ||||||||||||
| Estimated Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Not Provided | ||||||||||||
| Removed Location Countries | |||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT03937583 | ||||||||||||
| Other Study ID Numbers ICMJE | PEETAC 2018-003958-25 ( EudraCT Number ) |
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| Has Data Monitoring Committee | No | ||||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | ||||||||||||
| Study Sponsor ICMJE | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| PRS Account | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | ||||||||||||
| Verification Date | May 2019 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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