INSPIRE: a Multi-Cancer Early Detection Study

Singlera Genomics

Status

Enrolling

Conditions

Breast Cancer

Esophageal Cancer

Lung Cancer

Cholangiocarcinoma

Ovarian Cancer

Liver Cancer

Endometrial Cancer

Bladder Cancer

Gastric Cancer

Prostate Cancer

Cervical Cancer

Pancreatic Cancer

Colorectal Cancer

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06440018

multiple

Details and patient eligibility

About

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

Full description

Cancerous tissues, their adjacent non-cancerous tissues, along with white blood cells (WBCs) and normal tissue samples will be utilized to identify potential methylation candidate markers and investigate variations in methylation patterns among patients diagnosed with distinct cancer types. Building upon previous research and current study, a comprehensive methylation signature panel tailored specifically to cancer patients will be established.

We will prospectively collect blood samples from newly diagnosed cancer patients and non-cancer individuals to analyze and identify specific cancer signals via the detection of cfDNA methylation patterns. Following a rigorous and comprehensive research framework, a machine learning-driven model will be developed and validated through blinded testing in an independent cohort. The study aims to enroll approximately 2,650 cancer patients, with a focus on including early-stage cases to enhance the model's sensitivity in detecting cancers with favorable prognoses. Furthermore, around 2,400 control subjects, matched with cancer patients by age and gender and screened negative for cancer through routine tests, will participate as healthy or benign-condition volunteers in model development. Lastly, samples from an additional 300 patients with other tumors will be gathered to conduct interference testing, ensuring the robustness of the model's performance.

Enrollment

5,350 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Case Arm Participants:

40-75 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

Exclusion Criteria for Case Arm Participants:

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

Inclusion Criteria for Control Arm Participants:

40-75 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 Criteria for Control Arm Participants:

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