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

May 28, 2024 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

Not yet 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

Study Contact Backup

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

N/A

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

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 (Estimated)

June 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

May 28, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • multiple

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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