RecruitingNCT06440018

INSPIRE: a Multi-Cancer Early Detection Study

INSPIRE: Integrating Circulating DNA Methylation and Fragmentomics to Scan and Pinpoint Cancer Signals Effectively

Sponsor

Singlera Genomics Inc.

Enrollment

5,350 participants

Start Date

Jul 20, 2024

Study Type

OBSERVATIONAL

Conditions

Liver Cancer Gastric Cancer Lung Cancer

Summary

This research constitutes a multi-centric, case-control designed investigation aimed at developing and implementing a blinded validation of a machine learning-powered, multi-cancer early detection model. This is to be achieved through the prospective collection of blood specimens from newly diagnosed cancer patients and individuals devoid of a confirmed cancer diagnosis

Eligibility

Min Age: 40 YearsMax Age: 75 Years

Inclusion Criteria7

years old
Clinically and/or pathologically diagnosed cancer
No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
Able to provide a written informed consent and willing to comply with all part of the protocol procedures
years old
Without confirmed cancer diagnosis
Able to provide a written informed consent and willing to comply with all part of the protocol procedures

Exclusion Criteria14

Pregnancy or lactating women
Known prior or current diagnosis of other types of malignancies comorbidities
Have participated in an "interventional" clinical trial within the past 30 days and have taken the experimental drug;
Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
Recipients of blood transfusion within 30 days prior to screen
Recipients of therapy in past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
Failure to collect blood on time according to plan
The blood sample does not meet the requirements
Pregnancy or lactating women
No previous history of malignancy in other sites
Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
Recipients of blood transfusion within 30 days prior to screen
Recipients of therapy in the past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
Unsuitable for this trial determined by the researchers