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Clinical Trials in China / NCT04405557
Active, not recruiting Observational

The PREDICT Study: Prospective Early Detection In a Population at High-risk for Common Malignant Tumor

NCT04405557 · tracked via the Priya Life Science China tracker
Sponsor
Geneplus-Beijing Co. Ltd.
Phase
Observational
Started
2019-11-12
Last updated
2025-09-04

Condition(s) studied

Early Detection of Cancer

Study 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.

Eligibility

Sex
ALL
Min age
45 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Patients aged at or over 45 years old. 2. Patients who with one or more of the following situations: 1. 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. 2. Patients with viral hepatitis (Hepatitis B / C surface antigen positive with liver function damage. 3. Patients with liver nodules detected by ultrasound and hemangioma excluded. 4. Patients with compensated cirrhosis. 5. 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). 6. Patients with ovarian masses found by ultrasonography (premenopausal \> 5cm, postmenopausal \> 3.5cm). 7. Patients with pancreatic space-occupying found by ultrasonography. 8. Patients with BI-RADS grade 4 or above by ultrasound or mammography. 9. CA125\>35U/ml and BI-RADS above grade 3 by ultrasound or mammography. 10. CA153\>25U/ml and BI-RADS above grade 3 by ultrasound or mammography. 11. Family genetic history of breast cancer and ovarian cancer, and BI-RADS above grade 3 by ultrasound or mammography. 12. Patients with a positive fecal occult blood test and haemorrhoids excluded 13. Patients with a positive fecal occult blood test and positive CEA 14. More than 2 items were abnormal in PGI, PGR and G-17 (criteria: PGI≤70 UG/L, PGR≤7.0, G-17≤1 pmol/L or G-17≥15 pmol/L). 3. Ability to collect specimens from each time point and provide corresponding clinical information. 4. Understand the research plan and voluntarily participate in the study, sign the informed consent form. Exclusion Criteria: 1. Patients with previous or present cancer. 2. Patients with serious diseases, especially those with a survival period of less than 3 years. 3. Patients with factors that affect the diagnosis of the disease (such as MRI related cardiac pacemakers, ferromagnetic implants, etc.). 4. Patients with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 5. Women who are pregnant or preparing for pregnancy. 6. Patients who voluntarily withdraw for any reason. 7. Patients who cannot complete the research plan

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Chinese PLA General Hospital Beijing Beijing Municipality
Shenzhen People's Hospital Shenzhen Guangdong
Henan Provincial People's Hospital Zhengzhou Henan
Xiangya Hospital Central South University Changsha Hunan
Jiangsu Province Hospital Nanjing Jiangsu
China-Japan Union Hospital of Jilin University Changchun Jilin
The First Affiliated Hospital of Jinzhou Medical University Jinzhou Liaoning
Sichuan Provincial People's Hospital Chengdu Sichuan

More Geneplus-Beijing Co. Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04405557 on ClinicalTrials.gov ↗ ← All trials in China