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
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
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)
- Analysis of ctDNA for early detection in cancer high-risk population. — 1 year
To evaluate the sensitivity, specificity and positive predictive value of ctDNA for screening in high-risk population. Including the following six types of cancer: hepatocellular carcinoma, pancreatic cancer, ovarian cancer, breast cancer, colorectal cancer and gastric cancer.
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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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