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

NCT ID: NCT05227534

Last Updated: 2022-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2028-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cancer Early Detection of Cancer Circulating Cell-free DNA

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

OverC multi-cancer detection blood test

Intervention Type DEVICE

Blood collection for the OverC multi-cancer detection blood test and standard-of-care screening with return of results

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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West China Hospital

OTHER

Sponsor Role collaborator

Guangzhou Burning Rock Dx Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shangli Cai

Role: CONTACT

13811823843

Facility Contacts

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Weimin Li

Role: primary

18980601009

Other Identifiers

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RSCD2022006

Identifier Type: -

Identifier Source: org_study_id

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