An observational study in Neoplasms and Cancer, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-25.
Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Observational
Liquid biopsy technology based on cell-free nucleic acids and protein characteristics has unique advantages and significant application prospects in cancer early detection. The purpose of this study is to collect peripheral blood samples from participants with new diagnosis of cancer and from participants who do not have a diagnosis of cancer in order to develop machine learning models for discovering cancer from non-cancer.
The PROFUTURE study: A prospective, multicenter, observational, case-control study with collection of peripheral blood and clinical data from clinical networks in order to develop machine learning models for discovering cancer from non-cancer. According to the statistical hypothesis based on expected detection performance, the study will enroll approximately 3,830 participants, including 2,138 participants with cancer (case arm) and approximately 1,692 representative participants without a clinical diagnosis of cancer after medical screening (control arm). Participants pre-matched by age and gender will be divided into training set and validation set in a ratio of approximately 7:3. The validation set will be blinded until the models are developed. Clinical information, demographics, and medical data relevant to cancer status are collected from all participants and their medical records at baseline. The participants of control arm will be asked to report suspected cancer diagnosis status within 6 months after blood collection.
Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 211 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Eligible participants will be recruited from medical centers and communities. Participants will be assigned into two arms, including participants with new diagnosis of cancer and participants without a clinical diagnosis of cancer after medical screening. Demographic and cancer risk-related characteristics (eg, age, gender, smoking status, alcohol consumption) will be collected from all enrolled subjects.
Exclusion Criteria for Cancer Arm Participants:
Inclusion Criteria for Non-Cancer Arm Participants:
Exclusion Criteria for Non-Cancer Arm Participants:
Device: Multi-cancer early detection test
Device: Multi-cancer early detection test
Blood collection and multi-cancer early detection test
Sensitivity of predefined five types of cancers and specificity of non-cancers and in different subgroup of cfDNA methylation-based model at 95% confidence interval.
Time frame: 12 months
Tissue of origin (TOO) accuracy of five types of cancers of cfDNA methylation-based model at 95% confidence interval.
Time frame: 12 months
Sensitivity, specificity and TOO accuracy of five types of cancers of a multi-omics model at 95% confidence interval.
Time frame: 12 months
Sensitivity, specificity and TOO accuracy of cfDNA methylation-based model and multi-omics model in different stages or pathological types of five types of cancers at 95% confidence intervals.
Time frame: 12 months
Plan to share: No
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This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Sixth Affiliated Hospital, Sun Yat-sen University