An observational study in Cancer Diagnosis, LungCancer and Gastric Cancer, sponsored by Air Force Military Medical University, China. Recruiting at 8 sites in China. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Air Force Military Medical University, China · Observational
The goal of this observational study is to screen and differentiate common cancers in participants with or without suspicious lesions. The main question the investigators aim to answer is: Can the developed model, using peripheral blood cell-free DNA sequencing, work well in screening and classifying common cancers especially in the early stages? Participants will undergo the collection of 15\~20ml of blood and 1\~2 telephone follow-up calls.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's planned enrollment of 3,200 is above the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Air Force Military Medical University, China is the lead sponsor of 172 studies on the registry; 36 are open to participants now.
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PASS 21.0 is used to calculate the sample size for diagnostic tests. Based on the specificity and sensitivity of different cancer diagnoses in current and reported studies, the specificity is preset at 98%, and the sensitivity is preset at 75%. A two-sided test is chosen, with a confidence level of 1-α=0.9, and a confidence interval width of 10%. The minimum sample size for the diagnostic test is calculated as follows: each type of cancer should have no less than 202 cases in the diagnostic test, and the total number of cancer subjects should not be less than 1414. The ratio of cancer subjects to non-cancer subjects is set at 1:1. Considering the possibility of loss to follow-up, unqualified sample quality, and dropout during the study, the sample size for this study is preset at 3200.
Non-cancer group: Individuals who have not been diagnosed with cancer during routine physical examinations and one-year follow-up.
Exclusion Criteria:
The cohort, including cancer patients and non-cancer patients, will be prospectively enrolled in from different departments and centers. The focused cancers include lung cancer, gastric cancer, colorectal cancer, liver cancer, esophagus cancer, breast cancer and pancreas cancer.
diagnostic accuracy
This refers to the ability of the test (peripheral blood cell-free DNA sequencing) to correctly classify individuals into the categories of having or not having the disease. It is a measure of the test's overall effectiveness. The reference test is histological test for cancers or one-year follow-up for non-cancers.
Time frame: Immediately after test completion
sensitivity
This is the ability of the test (peripheral blood cell-free DNA sequencing) to correctly identify those with the disease. It is the proportion of true positive results (those with the disease who test positive) to the total number of individuals who actually have the disease. The reference test is histological test for cancers or one-year follow-up for non-cancers.
Time frame: Immediately after test completion
specificity
This is the ability of the test (peripheral blood cell-free DNA sequencing) to correctly identify those without disease. It is the proportion of true negative results (those without the disease who test negative) to the total number of individuals who actually do not have the disease. The reference test is histological test for cancers or one-year follow-up for non-cancers.
Time frame: Immediately after test completion
Plan to share: No
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Air Force Military Medical University, China