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

NCT05227534 | Recruiting DMC

• 1 other identifier: RSCD2022006
• Study Type: interventional
• Target: 12,500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer; Early Detection of Cancer; Circulating Cell-free DNA

Outcome Measures

Primary Outcomes (2)

• The cancer clinical stages of cancer patients diagnosed via the multi-cancer detection blood test

  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

  Up to 1 year

Secondary Outcomes (4)

• 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)

  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

  Up to 5 years

• Satisfaction with the multi-cancer detection test

  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

  Up to 5 years

Study Arms (1)

Participants 40 years of age or older with cancer risk

EXPERIMENTAL

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

Interventions

OverC multi-cancer detection blood test DEVICE

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

Participants 40 years of age or older with cancer risk

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou Burning Rock Dx Co., Ltd.: lead
• West China Hospital: collaborator

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610044, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Shangli Cai

CONTACT

13811823843; shangli.cai@brbiotech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 7, 2022
• Study Start: June 1, 2022
• Primary Completion: March 1, 2024
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)