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 enrollmentNovember 12, 2019

ConditionsEarly Detection of Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Early Detection of Cancer
Sponsor: Geneplus-Beijing Co. Ltd.
Enrollment: 757
Locations: 8
Primary Endpoint: Analysis of ctDNA for early detection in cancer high-risk population.
Status: Active, not recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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).

Registry

clinicaltrials.gov

Start Date

November 12, 2019

End Date

December 31, 2026

Last Updated

8 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Geneplus-Beijing Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.

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.