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

Active, not recruiting

• Conditions: Early Detection of Cancer

• Registration Number: NCT04405557
• Lead Sponsor: Geneplus-Beijing Co. Ltd.

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 Timeline

• Study Start: 2019-11-12
• Study First Submitted: 2020-05-09
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-28
• Primary Completion: 2022-01-16
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-18
• Study Completion: 2025-01-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 757

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Window period from ctDNA positive to cancer diagnosis.	1 year	To evaluate the time from ctDNA positive to cancer diagnosis for patients diagnosed with cancer during the trial period.

Trial Locations

Locations (8)

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China

Shenzhen People's Hospital; 🇨🇳 Shenzhen, Guangdong, China

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Xiangya Hospital Central South University; 🇨🇳 Changsha, Hunan, China

The First Affiliated Hospital of Jinzhou Medical University; 🇨🇳 Jinzhou, Liaoning, China

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China

China-Japan Union Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China