Overview
This is a observational, multicenter study, monitoring the circulating tumor DNA (ctDNA) in people who is at risk of cancersassessing the sensitivity and specificity of ctDNA detection in early screening of pan-carcinoma.
Description
2000 patients with positive tumor protein markers or cancer screening were recruited. All patients were tested for ctDNA at enrollment and followed up at 6 months and 1 year. The study was completed at the time of cancer diagnosis or the longest follow-up time (1 year).
Eligibility
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).
- Patients with pancreatic space-occupying found by ultrasonography.
- Patients with BI-RADS grade 4 or above by ultrasound or mammography.
- CA125>35U/ml and BI-RADS above grade 3 by ultrasound or mammography.
- CA153>25U/ml and BI-RADS above grade 3 by ultrasound or mammography.
- Family genetic history of breast cancer and ovarian cancer, and BI-RADS above grade 3 by ultrasound or mammography.
- Patients with a positive fecal occult blood test and haemorrhoids excluded
- Patients with a positive fecal occult blood test and positive CEA
- More than 2 items were abnormal in PGI, PGR and G-17 (criteria: PGI70 UG/L, PGR7.0, G-171 pmol/L or G-1715 pmol/L).
- Ability to collect specimens from each time point and provide corresponding clinical information.
- Understand the research plan and voluntarily participate in the study, sign the informed consent form.
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.
- Women who are pregnant or preparing for pregnancy.
- Patients who voluntarily withdraw for any reason.
- Patients who cannot complete the research plan