Clinical trial NCT06790355: ProSight: a Multi-centre Interventional Study Evaluating MCED in Asymptomatic Population
Official title: Feasibility of Blood-based Test for Multi-cancer Early Detection in Asymptomatic Screening Population（ProSight）: a Multi-centre Interventional Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancer
Colorectal Cancer
Liver Cancer
Grastic Cancer
Esophageal Cancer
Keywords: multi-cancer early detection
MCED
cancer screening
circulating cell-free tumor DNA
methylation
Lead sponsor: Shanghai Weihe Medical Laboratory Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Fudan University Shanghai Cancer Center ( FUSCC )
First posted: 2025-01-24
Enrollment: 2527
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

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)

Primary outcomes:
measure: Feasibility of MCED in the intended use setting.
timeFrame: From enrollment to the Follow-up at 1 year
measure: Safety of MCED in the intended use setting.
timeFrame: From enrollment to the Follow-up at 1 year
Secondary outcomes:
measure: Performance of MCED in the intended use setting.
timeFrame: From enrollment to the Follow-up at 1 year
measure: Cancer signal origin accuracy of MCED.
timeFrame: From enrollment to the Follow-up at 1 year
measure: Clinical utility of MCED alongside SOC screening.
timeFrame: From enrollment to the Follow-up at 1 year
measure: Participant-reported psychological impact.
timeFrame: From enrollment to the Follow-up at 1 year
measure: Participant-reported health related quality of life (HRQoL) .
timeFrame: From enrollment to the Follow-up at 1 year
Other outcomes:
measure: Participant-reported satisfaction with MCED.
timeFrame: From enrollment to the Follow-up at 1 year
measure: Cross-reactivity of MCED.
timeFrame: From enrollment to the Follow-up at 1 year
Locations:
Study officials:
affiliation: Fudan University Shanghai Cancer Center ( FUSCC )
name: Xianjun Yu
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Weihe Medical Laboratory Co., Ltd.
name: Xiaohui Wu
role: STUDY_DIRECTOR
References: