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New treatment option for Heavy Smokers
Official title Akershus Cardiac Examination (ACE) 5 Study
ClinicalTrials.gov ID: NCT07301489
What this study is testing
- What it's testing
- Individuals with extensive smoking history have 2- to 3-fold increased risk of dying prematurely compared to age- and gender-matched peers. Historical data indicate that 55% of heavy smokers will die from cardiovascular disease (CVD), while approximately 5% will die from lung cancer.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 79
You may be able to join if
- used for the lung cancer screening implementation study/ TIDL Study:
- Women and men
- Ages 60 to 79 years old (inclusive)
- A smoking history of at least 35 pack-years and 1) being a current smoker or a former smoker who quit less than 10 years prior or 2) having a...
- Willingness and ability to comply with scheduled visits, laboratory tests, and other trial procedures
You likely can't join if
- used for the lung cancer screening implementation study/ TIDL Study:
- Recent abnormal pulmonary findings under work-up of standard care
- Having had chest CT \<1 year before potential entry into the study
- Current or prior history of lung cancer, renal cancer, melanoma or breast cancer
- Inability to provide signed informed consent
- Insufficient understanding of the languages in which trial information is available
See the full eligibility criteria
- used for the lung cancer screening implementation study/ TIDL Study:
- Women and men
- Ages 60 to 79 years old (inclusive)
- A smoking history of at least 35 pack-years and 1) being a current smoker or a former smoker who quit less than 10 years prior or 2) having a PLCOm2012 model 6-year risk for lung cancer incidence over 2.6%.
- Willingness and ability to comply with scheduled visits, laboratory tests, and other trial procedures
- Written informed consent obtained prior to performing any protocol-related procedures
- The participant should be affiliated to a social security system
- used for the lung cancer screening implementation study/ TIDL Study:
- Recent abnormal pulmonary findings under work-up of standard care
- Having had chest CT \<1 year before potential entry into the study
- Current or prior history of lung cancer, renal cancer, melanoma or breast cancer
- Inability to provide signed informed consent
- Insufficient understanding of the languages in which trial information is available
- Psychiatric or other disorders that are incompatible with compliance to the protocol requirements and follow-up
- Unable to be followed-up for at least 5-years
- Body weight \>140 Kg because of difficulty of conducting the CT exam Inclusion Criteria used for the ACE 5 Study:
- Participants from the TIDL Study with non-contrast, non-cardiac chest CT images available as part of the implementation lung cancer screening study
- Signed consent for cardiovascular add on-study and agree to protocol, including follow-up visit 1-year after the baseline examination Exclusion Criteria used for the ACE 5 Study:
- Any surgical or medical condition, including short life-expectancy, based on medical records or clinical findings prior to randomization, that will impair the ability of the patient to participate in the study
- Patients unwilling or unable to comply with the protocol
- History of non-compliance to medical management and patients who are considered potentially unreliable, based on information obtained prior to randomization
- History or evidence of alcohol or drug abuse with the last 12 months, based on information obtained prior to randomization, that will influence study participation
The study team makes the final eligibility decision.
Where it's taking place
- Lørenskog, Akershus, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lørenskog, Akershus, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.