The PREDICT Study: Prospective Early Detection In a Population at High-risk for Common Malignant Tumor

NCT04405557 | Active Not Recruiting

• 1 other identifier: PREDICT
• Study Type: observational
• Target: 757
• Locations: 1 country
• Sites: 8

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.

Conditions

Early Detection of Cancer

Keywords

Pan-cancer; cancer screening; ctDNA

Outcome Measures

Primary Outcomes (1)

• Analysis of ctDNA for early detection in cancer high-risk population.

  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.

  1 year

Secondary Outcomes (1)

• Window period from ctDNA positive to cancer diagnosis.

  1 year

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with positive tumor protein marker or cancer screening.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Geneplus-Beijing Co. Ltd.: lead
• Chinese PLA General Hospital: collaborator

Study Sites (8)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

China-Japan Union Hospital of Jilin University

Changchun, Jilin, 130033, China

Location

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, 121001, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma

Study Officials

• Qiang Zeng, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 28, 2020
• Study Start: November 12, 2019
• Primary Completion: January 16, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

CN (8)