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Not yet recruiting NCT06790355

ProSight: a Multi-centre Interventional Study Evaluating MCED in Asymptomatic Population

No phase Interventional Lung Cancer Colorectal Cancer Liver Cancer Grastic Cancer

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: multi-cancer early detection.
Who it may be relevant to
Registry conditions: Lung Cancer, Colorectal Cancer, Liver Cancer, Grastic Cancer. Basic parameters: 40 years — 74 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
Center list to be confirmed — check the primary protocol.
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

Feasibility of Blood-based Test for Multi-cancer Early Detection in Asymptomatic Screening Population（ProSight）: a Multi-centre Interventional Study

Overview

This is a prospective, multi-centre interventional study evaluating the feasibility of blood-based multi-cancer early detection test in asymptomatic screening cohort.

Detailed description

Approximately 2527 participants will be enrolled and offered the multi-cancer early detection (MCED) test along with standard-of-care (SOC) cancer screenings and usual medical care. The investigational test is designed to detect five cancer types at a curable stage, which are lung cancer, colorectal cancer, liver cancer, gastric cancer and esophageal cancer. The test provides a binary result and predicts the signal origins if a cancer signal is detected. Those with "cancer signal detected" test results as well as those with warning signs of cancer during health check-up will undergo diagnostic procedures. The diagnostic work-up will be at the discretion of qualified oncologists, instead of being dictated by protocol.

Both the safety and performance of MCED in the screening setting will be evaluated. The extent of diagnostic testing, including laboratory and imaging tests and procedures required to achieve diagnostic resolution, will be recorded and assessed. Additionally, patient-reported outcomes relating to the testing experience will also be collected at specified time points using the Electronic Clinical Outcome Assessment (eCOA) app.

Participants will be actively followed for 1 year from the date of the blood draw.

Interventions

  • Device multi-cancer early detection
    Blood collection for multi-cancer early detection（MCED）, followed by clinical diagnosis based on the results of MCED and standard-of-care screening

Primary outcome measures

  • Feasibility of MCED in the intended use setting. [Time frame: From enrollment to the Follow-up at 1 year]
  • Safety of MCED in the intended use setting. [Time frame: From enrollment to the Follow-up at 1 year]
Secondary outcome measures (5)
  • Performance of MCED in the intended use setting. [Time frame: From enrollment to the Follow-up at 1 year]
  • Cancer signal origin accuracy of MCED. [Time frame: From enrollment to the Follow-up at 1 year]
  • Clinical utility of MCED alongside SOC screening. [Time frame: From enrollment to the Follow-up at 1 year]
  • Participant-reported psychological impact. [Time frame: From enrollment to the Follow-up at 1 year]
  • Participant-reported health related quality of life (HRQoL) . [Time frame: From enrollment to the Follow-up at 1 year]

Eligibility criteria

Inclusion criteria

  • 40-74 years old
  • Able to provide a written informed consent and willing to comply with all parts of the protocol procedures

Exclusion criteria

  • With cancer-associated clinical symptoms or suspected of cancer within 30 days prior to screen
  • Have definite contraindications of cancer screening examination and diagnostic procedures
  • Unable to comply with the protocol procedures
  • Personal history of cancer, diagnosed within the 3 years prior to expected enrollment date
  • Have received or are undergoing curative cancer treatment within three years prior to recruitment. Adjuvant endocrinotherapy for cancer is not an exclusion criterion.
  • Recipients of anti-tumor therapy within 30 days prior to screen
  • Pregnancy or lactating women
  • Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
  • Recipients of blood transfusion within 7 days prior to screen
  • With autoimmune diseases
  • Have an acute infection or inflammation or uncontrolled chronic infection within 14 days prior to blood draw
  • Unsuitable for this trial determined by the researchers (eg. hemorrhagic diseases)

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

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06790355 · Genie-ProSight

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗