Multi-canceR Early-detection Test in Asymptomatic Individuals (PREVENT) (PREVENT)

June 30, 2022 updated by: Guangzhou Burning Rock Dx Co., Ltd.

A Prospective Multi-canceR Early-detection and interVENTional Study in Asymptomatic Individuals: PREVENT

PREVENT is a prospective, multicenter, interventional study evaluating the performance of the OverC multi-cancer detection blood test in asymptomatic individuals with cancer risk.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will receive the OverC multi-cancer detection blood test along with standard-of-care screening, whose results will be returned to health care providers and participants. The diagnostic procedures will be guided firstly by the OverC multi-cancer detection blood test and then by the standard-of-care screening. The number, cancer types, and cancer clinical stage of cancer patients diagnosed via the OverC multi-cancer detection blood test will be recorded.

The study will enroll approximately 12,500 participants as defined by eligibility criteria with an anticipated enrollment period of approximately 9 months at up to 30 clinical sites within China. Participants will be actively followed for approximately 5 years from the date of their enrollment.

Study Type

Interventional

Enrollment (Anticipated)

12500

Phase

  • Not Applicable

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

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610044
        • Recruiting
        • West China Hospital, Sichuan University
        • 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

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must be able to provide a written informed consent form
  • Participants must not have received any colonoscopy, abdominal MRI/CT, low-dose CT, or chest CT within 5 years before signing the informed consent form
  • Participants must be able to provide blood samples for study tests
  • Participants must be between 40 and 75 years old

Exclusion Criteria:

  • Individuals who have an acute infection or inflammation within 14 days prior to recruitment
  • Individuals with cancer-associated clinical symptoms or suspected of cancer
  • Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
  • Recipient of blood transfusion within 7 days prior to recruitment
  • Individuals who have pure ground-glass opacity
  • Unable to provide blood samples for the multi-cancer early detection blood test
  • Individuals who are unable to tolerate standard-of-care cancer screening tests or have contraindications of standard-of-care cancer screening tests
  • Individuals who have taken medication with anti-tumor effects within 30 days prior to recruitment
  • Individuals who have received or are undergoing curative cancer treatment within three years prior to recruitment
  • Individuals with hemorrhagic diseases
  • Individuals with autoimmune diseases
  • Individuals who are pregnant or lactating
  • Individuals who have severe comorbidities that are not suitable for participating in the trial judged by researchers

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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants 40 years of age or older with cancer risk
The study will aim to enroll participants 40 years of age or older with cancer risk. Specific cancer risks will be enriched to increase the number of cancer events that are observed during the study.
Device: OverC multi-cancer detection blood test
Blood collection for the OverC multi-cancer detection blood test and standard-of-care screening with return of results

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The cancer clinical stages of cancer patients diagnosed via the multi-cancer detection blood test
Time Frame: Up to 5 years
Up to 5 years
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for the multi-cancer detection test alone or with standard-of-care screening as evaluated after 1-year follow-up
Time Frame: Up to 1 year
Up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in health-related quality of life in individuals with a positive result of the multi-cancer detection test assessed by Short Form Health Survey (SF-12v2)
Time Frame: Up to 5 years
The SF-12v2 is a measure of health related quality of life including physical component summary (PCS) and mental component summary (MCS). Both PCS and MCs have scores that range from 0 to 100. Higher values represent better health.
Up to 5 years
Changes in anxiety as evaluated by Self-rating Anxiety Scale (SAS) of individuals with a positive result of the multi-cancer detection test
Time Frame: Up to 5 years
Assessed by Self-rating Anxiety Scale (SAS). Range in score from 25 to 100 with higher scores indicate greater severity of anxiety.
Up to 5 years
Satisfaction with the multi-cancer detection test
Time Frame: Up to 5 years
Satisfaction will be measured by a self-reported questionnaire. Range in ranks from very satisfied, satisfied, general, unsatisfied, to very unsatisfied.
Up to 5 years
Sensitivity, specificity, PPV, and NPV for the multi-cancer detection blood test alone or with standard-of-care screening as evaluated after 3- and 5-year follow-up
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

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

Sponsor

Guangzhou Burning Rock Dx Co., Ltd.

Collaborators

West China 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)

June 1, 2022

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

December 31, 2028

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

February 7, 2022

Study Record Updates

Last Update Posted (Actual)

July 6, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • RSCD2022006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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