The PREDICT Study: Prospective Early Detection In a Population at High-risk for Common Malignant … (NCT04405557) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The PREDICT Study: Prospective Early Detection In a Population at High-risk for Common Malignant Tumor
China757 participantsStarted 2019-11-12
Plain-language summary
This is a observational, multicenter study, monitoring the circulating tumor DNA (ctDNA) in people who is at risk of cancers，assessing the sensitivity and specificity of ctDNA detection in early screening of pan-carcinoma.
Who can participate
Age range45 Years
SexALL
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Inclusion criteria
✓. Patients aged at or over 45 years old.
✓. Patients who with one or more of the following situations:
✓. In AFP (\>20UG/L), CA125 (\>70U/ml), CEA (\>7ng/ml) and CA199 (\>60U/ml), more than one item was abnormal for two consecutive times within one month.
✓. Patients with viral hepatitis (Hepatitis B / C surface antigen positive with liver function damage.
✓. Patients with liver nodules detected by ultrasound and hemangioma excluded.
✓. Patients with compensated cirrhosis.
✓. CA125\>35U/ml and HE4 was abnormal (the reference value of HE4 in premenopausal and postmenopausal women was 68.96 pmol/L and 114.90 pmol/L respectively).
✓. Patients with ovarian masses found by ultrasonography (premenopausal \> 5cm, postmenopausal \> 3.5cm).
Exclusion criteria
✕. Patients with previous or present cancer.
✕. Patients with serious diseases, especially those with a survival period of less than 3 years.
✕. Patients with factors that affect the diagnosis of the disease (such as MRI related cardiac pacemakers, ferromagnetic implants, etc.).
✕. Patients with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
What they're measuring
1
Analysis of ctDNA for early detection in cancer high-risk population.