Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Screening for Cancer in Patients With Thromboembolic Disease (PEETAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937583
Recruitment Status : Not yet recruiting
First Posted : May 6, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolic Disease Respiratory Disease Pulmonary Disease Deep Venous Thrombosis Pulmonary Embolism Drug: Fludeoxyglucose 18F Phase 2

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.

Layout table for study information
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
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.
Experimental: Extended screening
Limited screening plus positron emission tomography / computed tomography with 18 FDG (18FDG PET-CT).
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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937583


Contacts
Layout table for location contacts
Contact: Luis Jara Palomares, MD/PhD +34 955012144 luisoneumo@hotmail.com
Contact: Clara M Rosso Fernández, MD/PhD +34955012144 claram.rosso.sspa@juntadeandalucia.es

Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
Layout table for investigator information
Principal Investigator: Luis Jara Palomares, MD/PhD Hospitales Universitarios Virgen del Rocío
Layout table for additonal information
Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT03937583    
Other Study ID Numbers: PEETAC
2018-003958-25 ( EudraCT Number )
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD to be shared with the center participants once the study is officially finished in the foreseen period of three years.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 3 years time

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Venous Thromboembolic Disease
Pulmonary Embolism
Extended screening
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Embolism
Respiration Disorders
Thrombosis
Embolism
Venous Thrombosis
Thromboembolism
Respiratory Tract Diseases
Lung Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases