INSPIRE: a Multi-Cancer Early Detection Study (INSPIRE)

February 19, 2025 updated by: Singlera Genomics Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

5350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Zhixi Su, PHD
Phone Number: 1022 +862180113170
Email: zhixi.su@singlera.com

Study Contact Backup

Name: Rui Liu
Phone Number: 1027 +862180113170
Email: rliu@singlera.com

Study Locations

China
- Shnaghai
  - Shanghai, Shnaghai, China, 200433
    - Recruiting
    - Fudan University
    - Contact:
      
      Chen Suo, PhD
      
      Phone Number: 86-21-54237625
      
      Email: suochen@fudan.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

A consenting professional will invite participants, including cancer patients and healthy controls, from the main center and affiliated hospitals, to take part in a comprehensive case-control study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Case arm Participants newly diagnosed with cancer, belonging to one of thirteen distinct cancer types.
Control arm Healthy or benign condition participants with no cancer diagnosis subsequent to routine cancer screening tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The AUC, sensitivity, specificity and tissue origin accuracy of the multi-cancer early detection model in detecting cancer or non-cancer Time Frame: 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The performance of the multi-cancer early detection model in early stage cancer and precancerous lesion cases Time Frame: 12 months	12 months
The performance of the multi-cancer early detection model in different subgroups (such as age, gender, cancer pathological classification, and clinical stage) Time Frame: 12 months	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singlera Genomics Inc.

Collaborators

Fudan University

Beijing Friendship Hospital

Shanxi Provincial Cancer Hospital

China-Japan Friendship Hospital

Anhui Provincial Hospital

Hubei Cancer Hospital, Huazhong University of Science and Technology

Xuhui Central Hospital, Fudan University

Shanghai Electric Power Hospital

East Hospital, Tongji University

The First Affiliated Hospital of Xi' an Jiaotong University

GaoZhou People's Hosipital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria