Key result
The DETECTOR prospective cohort study will evaluate the diagnostic value of combining low-dose chest CT and circulating tumor cell detection for early cancer screening in at least 300 high-risk patients with peripheral arterial disease.
Why the study?
Cancer mortality overtakes cardiovascular death in peripheral arterial disease, but the clinical benefit of a dedicated cancer screening workup in this high-risk smoking population has never been investigated.
Does a screening strategy combining low-dose chest CT and circulating tumor cell detection improve early cancer detection in high-risk patients with peripheral arterial disease and a history of heavy smoking?
Cohort (n=300)
Yes
Does a screening strategy combining low-dose chest CT and circulating tumor cell detection improve early cancer detection in high-risk patients with peripheral arterial disease and a history of heavy smoking?
The DETECTOR study will evaluate whether combining low-dose chest CT with circulating tumor cell detection can effectively screen for tobacco-related cancers in high-risk patients with peripheral arterial disease.
Value of combined low-dose CT and CTC screening for early cancer detection in high-risk PAD remains unproven; this cohort will yield hypothesis-generating data.
BACKGROUND: Smoking is a strong risk factor for cancer and atherosclerosis. Cancer mortality, especially from lung cancer, overtakes cardiovascular (CV) death rate in patients with peripheral arterial disease (PAD). Only a few patients with lung cancer after PAD management may benefit from surgical excision. Circulating tumor cells (CTC) associated with low-dose chest CT (LDCT) may improve early cancer detection. This study focuses on a screening strategy that can address not only lung cancer but all tobacco-related cancers in this high-risk population. METHODS: DETECTOR Project is a prospective cohort study in two French University hospitals. Participants are smokers or former smokers (≥30 pack-years, quitted ≤15 years), aged ≥55 to 80 years, with atherosclerotic PAD or abdominal aortic aneurysm. After the first screening round combining LDCT and CTC search on a blood sample, two other screening rounds will be performed at one-year interval. Incidental lung nodule volume, volume doubling time and presence of CTC will be taken into consideration for adapted diagnostic management. In case of negative LDCT and presence of CTC, a contrast enhanced whole-body PET/CT will be performed for extra-pulmonary malignancy screening. Psychological impact of this screening strategy will be evaluated in population study using a qualitative methodology. Assuming 10% prevalence of smoking-associated cancer in the studied population, a total of at least 300 participants will be enrolled. DISCUSSION: Epidemiological data underline an increase incidence in cancer and related death in the follow-up of patients with PAD, compared with the general population, particularly for tobacco-related cancers. The clinical benefit of a special workup for neoplasms in patients with PAD and a history of cigarette smoking has never been investigated. By considering CTCs detection in this very high-risk selected PAD population for tobacco-induced cancer, we expect to detect earlier pulmonary and extra-pulmonary malignancies, at a potentially curable stage. TRIAL REGISTRATION: The study was registered in the French National Agency for Medicines and Health Products Safety (No N° EUDRACT_ID RCB: 2016-A00657-44) and was approved by the ethics Committee for Persons Protection (IRB number 1072 and n° initial agreement 2016-08-02; ClinicalTrials.gov identifier NCT02849041).
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Yannoutsos et al. (2019) conducted a cohort in Peripheral arterial disease or abdominal aortic aneurysm (n=300). Low-dose chest CT combined with circulating tumor cell (CTC) detection was evaluated on Diagnostic value (sensitivity and specificity) of LDCT combined with CTC search for the early detection of smoking-associated cancers. The DETECTOR prospective cohort study will evaluate the diagnostic value of combining low-dose chest CT and circulating tumor cell detection for early cancer screening in at least 300 high-risk patients with peripheral arterial disease.
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