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

NCT06790355 | Not Yet Recruiting

• 1 other identifier: Genie-ProSight
• Study Type: interventional
• Target: 2,527
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• Feasibility of MCED in the intended use setting.

  Descriptive statistics will be used to summarize the number of 5 pre-specified cancers diagnosed by MCED.

  From enrollment to the Follow-up at 1 year

• Safety of MCED in the intended use setting.

  Descriptive statistics will be used to summarize the time to achieve diagnostic resolution following receipt of a positive MCED test and to assess the extent of testing pursued.

  From enrollment to the Follow-up at 1 year

Secondary Outcomes (5)

• Performance of MCED in the intended use setting.

  From enrollment to the Follow-up at 1 year

• Cancer signal origin accuracy of MCED.

  From enrollment to the Follow-up at 1 year

• Clinical utility of MCED alongside SOC screening.

  From enrollment to the Follow-up at 1 year

• Participant-reported psychological impact.

  From enrollment to the Follow-up at 1 year

• Participant-reported health related quality of life (HRQoL) .

  From enrollment to the Follow-up at 1 year

Other Outcomes (2)

• Participant-reported satisfaction with MCED.

  From enrollment to the Follow-up at 1 year

• Cross-reactivity of MCED.

  From enrollment to the Follow-up at 1 year

Study Arms (1)

Healthy subjects

EXPERIMENTAL

Device: multi-cancer early detection

Interventions

multi-cancer early detection DEVICE

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

Healthy subjects

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Shanghai Weihe Medical Laboratory Co., Ltd.: lead
• Fudan University: collaborator

MeSH Terms

Conditions

Lung Neoplasms; Colorectal Neoplasms; Liver Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Liver Diseases; Head and Neck Neoplasms; Esophageal Diseases

Study Officials

• Xianjun Yu

  Fudan University

  PRINCIPAL INVESTIGATOR

• Xiaohui Wu

  Shanghai Weihe Medical Laboratory Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Dan Qin

CONTACT

0086-15827587695; qindan.556@bytedance.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 12, 2025
• First Posted: January 24, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share