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

May 25, 2023 updated by: Geneplus-Beijing Co. Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

757

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Qiang Zeng, MD
  • Phone Number: 13911736252
  • Email: ZQ301@126.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Chinese PLA General hospital
        • Contact:
    • Guangdong
      • Shenzhen, Guangdong, China, 518020
        • Recruiting
        • ShenZhen People's Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130033
        • Recruiting
        • China-Japan Union Hospital of Jilin University
        • Contact:
    • Liaoning
      • Jinzhou, Liaoning, China, 121001
        • Recruiting
        • The First Affiliated Hospital of Jinzhou Medical University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People with positive tumor protein marker or cancer screening.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Window period from ctDNA positive to cancer diagnosis.
Time Frame: 1 year
To evaluate the time from ctDNA positive to cancer diagnosis for patients diagnosed with cancer during the trial period.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geneplus-Beijing Co. Ltd.

Collaborators

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Qiang Zeng, MD, Chinese PLA General hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2019

Primary Completion (Actual)

January 16, 2022

Study Completion (Estimated)

January 16, 2025

Study Registration Dates

First Submitted

May 9, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREDICT (CardioDx)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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