INSPIRE: A Multi-Cancer Early Detection Study

Breast Cancer Clinical Trial

— INSPIRE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06440018
• Other study ID #: multiple
• Status: Not yet recruiting
• Start date: June 20, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: May 2024
• Source: Singlera Genomics Inc.
• Contact: Zhixi Su, PHD
• Phone: +862180113170
• Email: zhixi.su[@]singlera.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5350
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Cancer
• Cervical Cancer
• Cholangiocarcinoma
• Colorectal Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Esophageal Cancer
• Gastric Cancer
• Liver Cancer
• Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer

Locations

Country	Name	City	State
n/a

Sponsors (12)

Lead Sponsor

Collaborator

Singlera Genomics Inc.

Anhui Provincial Hospital, Beijing Friendship Hospital, China-Japan Friendship Hospital, East Hospital, Tongji University, Fudan University, GaoZhou People's Hosipital, Hubei Cancer Hospital, Huazhong University of Science and Technology, Shanghai Electric Power Hospital, Shanxi Provincial Cancer Hospital, The First Affiliated Hospital of Xi' an Jiaotong University, Xuhui Central Hospital, Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The AUC, sensitivity, specificity and tissue origin accuracy of the multi-cancer early detection model in detecting cancer or non-cancer		12 months
Secondary	The performance of the multi-cancer early detection model in early stage cancer and precancerous lesion cases		12 months
Secondary	The performance of the multi-cancer early detection model in different subgroups (such as age, gender, cancer pathological classification, and clinical stage)		12 months