NCT04405557Active, not recruitingNot Applicable
Study on the Application of ctDNA in a Population at High-risk for Common Malignant Tumor
Geneplus-Beijing Co. Ltd.8 sites in 1 country757 target enrollmentStarted: November 12, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 757
- Locations
- 8
- Primary Endpoint
- Analysis of ctDNA for early detection in cancer high-risk population.
Study Overview
Brief 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.
Detailed 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).
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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: PGI≤70 UG/L, PGR≤7.0, G-17≤1 pmol/L or G-17≥15 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
Outcomes
Primary Outcomes
Analysis of ctDNA for early detection in cancer high-risk population.
Time Frame: 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.
Secondary Outcomes
- Window period from ctDNA positive to cancer diagnosis.(1 year)
Investigators
Study Sites (8)
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