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Recruiting NCT05227534

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

No phase Interventional Cancer Early Detection of Cancer Circulating Cell-free DNA

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OverC multi-cancer detection blood test.
Who it may be relevant to
Registry conditions: Cancer, Early Detection of Cancer, Circulating Cell-free DNA. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • 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

Primary outcome measures

  • The cancer clinical stages of cancer patients diagnosed via the multi-cancer detection blood test [Time frame: 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]
Secondary outcome measures (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) [Time frame: 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]
  • Satisfaction with the multi-cancer detection test [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

China · 1 center
  • West China Hospital, Sichuan University — Chengdu

Identifiers

NCT: NCT05227534 · RSCD2022006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗