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A Study of Lung Cancer Screening in People With Unexplained Weight Loss

Enrichment of Lung Cancer Screening Through Unexplained Weight Loss (UWL) to Stage Shift and Improve Survival

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 80 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: CT scans, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The lung cancer screening will involve use of low-dose computed tomography (LDCT), a CT scan that gives off very low doses of radiation and can make detailed pictures of the lungs to help find tumors."
  • "The study researchers will also analyze participants' blood samples to determine if blood testing can be used to help to diagnose lung cancer."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for people ages 50–80 who have unexplained weight loss and a history of smoking. It uses low-dose CT scans, which take detailed lung pictures with very little radiation, to compare lung cancer risk in people with and without unexplained weight loss. Researchers will also test blood samples to see if blood tests can help find lung cancer.

The researchers are doing this study to see if people with unexplained weight loss who have lung cancer screening are more likely to have or develop lung cancer than people without unexplained weight loss. The lung cancer screening will involve use of low-dose computed tomography (LDCT), a CT scan that gives off very low doses of radiation and can make detailed pictures of the lungs to help find tumors. The study researchers will also analyze participants' blood samples to determine if blood testing can be used to help to diagnose lung cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be ages 50–80 and meet American Cancer Society lung cancer screening rules, as judged by the screening team.
  • Have smoked at least 20 pack-years—for example, 1 pack a day for 20 years or 2 packs a day for 10 years.
  • Have lost 3%–10% of your body weight within the past 18 months, without a medical condition explaining the loss, as judged by the study doctor.
  • You may still qualify if you tried to lose weight but the study doctor does not think your efforts explain the loss.
  • Weight loss may be reported by you or recorded at doctor visits. If these disagree, the measured weights in your medical record will be used.
  • Your treating doctor expects you to live more than 1 year.

Who can't join

  • You are pregnant or trying to become pregnant.
  • You had a chest CT scan, including a low-dose screening scan, within the past 12 months.
  • You have had non-small cell lung cancer, a type of lung cancer. A history of cancers outside the lungs does not rule you out.
  • You are being tested or have been referred for tests because a doctor suspects cancer.
  • You have an inherited gene change known to cause disease and had a whole-body MRI scan within the past 12 months.
  • You cannot follow the study steps.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Eligible for American Cancer Society lung cancer screening, as follows as per the discretion of the screening team: * Age 50-80 years old * At least 20-pack year history of smoking * Weight loss of 3-10%, defined as UWL, within any timeframe over the past in the 18 months prior to enrollment, that cannot be attributed to an underlying medical condition at the discretion of the enrolling investigator * Note that patients who have 3-10% weight may still be enrolled if the enrolling investigator does not conclude that the weight loss can be attributed to the patient's intentional efforts. * Documented weight loss can be self-reported or extracted from weights obtained during physician visits. However, if self-reported weight loss is contradicted by weight loss documented in the medical record (e.g. a patients states that (s)he lost 10 lbs in the past 6 months, but a weight documented in the medical record does not support that history), the measured and quantified weight change will be used to ascertain eligibility * Life expectancy greater than 1 year, per assessment of the treating clinician. Exclusion Criteria: * Currently pregnant or trying to become pregnant via self-report * Prior history of recent CT scan of the chest either through LDCT screening or with a scan of the chest (standard, not LDCT) performed within the past 12 months * Prior history of NSCLC ○ Note that patients with a history of diagnosis of non-lung cancers are eligible for the study. * Currently undergoing or referred for diagnostic evaluation due to clinical suspicion for malignancy (e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the basis of a suspicious imaging abnormality). * Patients with a germline pathogenic genetic variant who have undergone whole body MRI within the past 12 months * Unable to comply with study procedures

Study sites (8)

NJ

NY