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

Early Detection of Cancer Clinical Trial

Official title:

Study on the Application of ctDNA in a Population at High-risk for Common Malignant Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04405557
• Other study ID #: PREDICT
• Status: Recruiting
• Start date: November 12, 2019
• Est. completion date: January 16, 2025

Study information

• Verified date: May 2023
• Source: Geneplus-Beijing Co. Ltd.
• Contact: Qiang Zeng, MD
• Phone: 13911736252
• Email: ZQ301[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 757
• Est. completion date: January 16, 2025
• Est. primary completion date: January 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Early Detection of Cancer
• Neoplasms

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing
China	China-Japan Union Hospital of Jilin University	Changchun	Jilin
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	The First Affiliated Hospital of Jinzhou Medical University	Jinzhou	Liaoning
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Geneplus-Beijing Co. Ltd.	Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Window period from ctDNA positive to cancer diagnosis.	To evaluate the time from ctDNA positive to cancer diagnosis for patients diagnosed with cancer during the trial period.	1 year