LDCT Screening for Lung Cancer in High-risk Black Women
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
Disqualifiers: Lung cancer, Lung symptoms, Pneumonia, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this research study is to study U.S. Black women with a history of smoking to examine the feasibility, acceptability, and performance of low-dose computed tomography (LDCT) screening among this population.
The name of the intervention used in this research study is:
Low-dose computed tomography (radiologic scan) chest scan
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Low-dose Computed Tomography (LDCT) for lung cancer screening in high-risk Black women?
Research shows that LDCT is effective in finding lung cancer early in people at high risk, which can lead to better chances of survival. It is especially useful for those over 49 years old with a history of smoking.
12345Is low-dose computed tomography (LDCT) safe for humans?
LDCT is generally safe, but it does have some risks like exposure to radiation, false-positive results that can lead to unnecessary procedures, and overdiagnosis of non-threatening cancers.
23678How is low-dose computed tomography (LDCT) different from other treatments for lung cancer?
Low-dose computed tomography (LDCT) is unique because it is a screening method, not a treatment, that helps detect lung cancer early in high-risk individuals, such as older adults with a history of smoking. Unlike other treatments that aim to cure or manage lung cancer, LDCT is used to find the disease at an early stage when it is more treatable.
135910Eligibility Criteria
This trial is for self-identified Black women aged 50 or older who have a history of smoking. There are no specific requirements on the amount they've smoked or how long ago they quit. Women with recent lung infections treated with antibiotics, a history of lung cancer, or current symptoms suggesting lung cancer (like shortness of breath, getting winded easily, chronic cough) cannot join.Inclusion Criteria
You have a history of smoking, regardless of how much or for how long.
I am 50 years old or older.
I am a Black woman.
Exclusion Criteria
I have symptoms like shortness of breath, getting easily winded, or a chronic cough in the last 12 weeks.
I was treated with antibiotics for pneumonia or a lung infection in the last 12 weeks.
I have had lung cancer in the past.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Questionnaire Completion
Participants complete questionnaires pre- and post- low-dose computed tomography (LDCT) test
1 week
2 visits (virtual)
LDCT Screening
Participants undergo a low-dose computed tomography (LDCT) screening test at Massachusetts General Hospital
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after LDCT screening
3 months
2 visits (in-person)
Participant Groups
The study is examining low-dose computed tomography (LDCT), which is a type of chest scan that uses less radiation than standard CT scans. It aims to check if this screening method is practical, acceptable and effective specifically in high-risk Black women smokers for early detection of lung cancer.
1Treatment groups
Experimental Treatment
Group I: Screening: Low-Dose Computed Tomography ScreeningExperimental Treatment1 Intervention
Participants will undergo study procedures as outlined:
* Complete questionnaires pre- and post- low-dose computed tomography (LDCT) test.
* Visit Massachusetts General Hospital facility for a LDCT screening test.
Low-dose Computed Tomography is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Low-dose CT scan for:
- Lung cancer screening in high-risk individuals aged 50 to 80 years with a 20 pack-year smoking history and currently smoke or have quit within the past 15 years
🇪🇺 Approved in European Union as Low-dose CT scan for:
- Lung cancer screening in high-risk individuals
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of ChicagoChicago, IL
Massachusetts General Hospital Cancer CenterBoston, MA
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
Agency for Healthcare Research and Quality (AHRQ)Collaborator
References
Risk-Targeted Lung Cancer Screening: A Cost-Effectiveness Analysis. [2022]Targeting low-dose computed tomography (LDCT) for lung cancer screening to persons at highest risk for lung cancer mortality has been suggested to improve screening efficiency.
Patient Adherence in an Academic Medical Center's Low-dose Computed Tomography Screening Program. [2023]Low-dose computed tomography (LDCT) screening is an important tool for reducing lung cancer mortality. This study describes a single center's experience with LDCT and attempts to identify any barriers to compliance with standard guidelines.
A meta-analysis: is low-dose computed tomography a superior method for risky lung cancers screening population? [2017]Low-dose computed tomography (LDCT) has been proposed to be a new screening method to discover lung cancers in an early stage, especially those patients who are in a high risk of lung cancer. The primary objective of this meta-analysis is to systematically review the effect of LDCT on screening for lung cancers among the risky population who are older than 49 years old and with smoking exposure.
The Case for Lung Cancer Screening: What Nurses Need to Know. [2017]Lung cancer screening with low-dose helical computed tomography (LDCT) can improve high-risk individuals' chances of being diagnosed at an earlier stage and increase survival.
Feasibility of lung cancer prediction from low-dose CT scan and smoking factors using causal models. [2022]Low-dose CT (LDCT) is currently used in lung cancer screening of high-risk populations for early lung cancer diagnosis. However, 96% of individuals with detected nodules are false positives.
Assessing the benefits and harms of low-dose computed tomography screening for lung cancer. [2020]The concept of using low-dose computed tomography (LDCT) for lung cancer screening goes back almost 25 years. In 2011, the National Lung Screening Trial (NLST) reported that LDCT screening significantly reduced mortality from lung cancer in a high risk population. This article evaluates the benefits and harms of LDCT screening, based largely on evidence from randomized trials. Harms include false-positive screens and resultant diagnostic procedures, overdiagnosed cancers, and radiation exposure. Benefits can be expressed as the number needed to be screened to prevent one lung cancer death or as estimated overall reductions in lung cancer mortality assuming LDCT population screening as recommended by guidelines. Indirect metrics of benefit, such as lung cancer survival and stage distribution, as well as measures of harms, will be important to monitor in the future as LDCT screening disseminates in the population.
Effective use of low-dose computed tomography lung cancer screening. [2016]Lung cancer screening programs for high-risk populations using low-dose computed tomography (LDCT) have been shown by a class I clinical trial to reduce lung cancer mortality by 20%. We present an overview of randomized and nonrandomized lung cancer screening trials and review some of the arguments advocating for or against the widespread implementation of such a screening program. Concerns regarding the use of LDCT screening for lung cancer include increased risk from radiation exposure, overdiagnosis of indolent tumors, and high numbers of false-positive results, which may increase patient anxiety and result in unnecessary procedures with potential complications. Current recommendations regarding diagnostic criteria and workup of positive screens as well as the risks and benefits of using LDCT for lung cancer screening are provided.
Lung Cancer Screening by Low-Dose Computed Tomography: Part 2 - Key Elements for Programmatic Implementation of Lung Cancer Screening. [2022]For screening with low-dose CT (LDCT) to be effective, the benefits must outweigh the potential risks. In large lung cancer screening studies, a mortality reduction of approx. 20 % has been reported, which requires several organizational elements to be achieved in practice.
Racial Differences in Outcomes within the National Lung Screening Trial. Implications for Widespread Implementation. [2022]Black individuals with lung cancer (LC) experience higher mortality because they present with more advanced disease and are less likely to undergo curative resection for early-stage disease. The National Lung Screening Trial (NLST) demonstrated improved LC mortality by screening high-risk patients with low-dose computed tomography (LDCT). The benefit of LDCT screening in black individuals is unknown.
National Lung Cancer Screening Utilization Trends in the Veterans Health Administration. [2022]Many Veterans are high risk for lung cancer. Low-dose computed tomography (LDCT) is an effective strategy for lung cancer early detection in a high-risk population. Our objective was to describe and compare annual and geographic utilization trends for LDCT screening in the Veteran's Health Administration (VHA).