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Clinical Trial Record

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INSPIRE: a Multi-Cancer Early Detection Study

2024-07-20

2025-02-28

2025-02-28

5350

Study Overview

INSPIRE: a Multi-Cancer Early Detection Study

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

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.

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

    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 Registration Dates Results Reporting Dates Study Record Updates

    2024-05-28  

    N/A  

    2025-02-19  

    2024-05-28  

    N/A  

    2025-02-21  

    2024-06-03  

    N/A  

    2024-05  

    Study Plan

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

    Design Details

    Primary Purpose:
    N/A

    Allocation:
    N/A

    Interventional Model:
    N/A

    Masking:
    N/A

    Arms and Interventions

    Participant Group/ArmIntervention/Treatment
    : 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.

    Primary Outcome MeasuresMeasure DescriptionTime Frame
    The AUC, sensitivity, specificity and tissue origin accuracy of the multi-cancer early detection model in detecting cancer or non-cancer12 months
    Secondary Outcome MeasuresMeasure DescriptionTime Frame
    The performance of the multi-cancer early detection model in early stage cancer and precancerous lesion cases12 months
    The performance of the multi-cancer early detection model in different subgroups (such as age, gender, cancer pathological classification, and clinical stage)12 months

    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: +862180113170

    Email: zhixi.su@singlera.com

    Study Contact Backup

    Name: Rui Liu

    Phone Number: +862180113170

    Email: rliu@singlera.com

    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.

    Ages Eligible for Study:
    ALL

    Sexes Eligible for Study:
    40 Years

    Accepts Healthy Volunteers:

      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

    Collaborators and Investigators

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

    • Fudan University
    • Hubei Cancer Hospital, Huazhong University of Science and Technology
    • China-Japan Friendship Hospital
    • Shaanxi Provincial Cancer Hospital
    • 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
    • Anhui Provincial Hospital
    • Beijing Friendship Hospital
    • : ,

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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