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NCT Number: NCT05227534

Multi-canceR Early-detection Test 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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610044, China

Location status: Recruiting

Location contact

Weimin Li

CONTACT

[email protected]

18980601009

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: Up to 5 years

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Shangli Cai

CONTACT

[email protected]

13811823843

Sponsors and collaborators

Lead sponsor

Guangzhou Burning Rock Dx Co., Ltd.

Industry

Collaborators

  • West China Hospital

Registry information

Official study title

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

Acronym: PREVENT

Important dates

Study start
2022
Primary completion
2024
Study completion
2028
First posted
Feb 7, 2022
Registry last updated
Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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