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)
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
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.
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