INSPIRE: a Multi-Cancer Early Detection Study

NCT06440018 | Recruiting

• 1 other identifier: multiple
• Study Type: observational
• Target: 5,350
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The AUC, sensitivity, specificity and tissue origin accuracy of the multi-cancer early detection model in detecting cancer or non-cancer

  12 months

Secondary Outcomes (2)

• The performance of the multi-cancer early detection model in early stage cancer and precancerous lesion cases

  12 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• years old
• Without confirmed cancer diagnosis
• Able to provide a written informed consent and willing to comply with all part of the protocol procedures
• 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

Sponsors & Collaborators

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

Study Sites (1)

Fudan University

Shanghai, Shnaghai, 200433, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue and blood samples

MeSH Terms

Conditions

Lung Neoplasms; Stomach Neoplasms; Liver Neoplasms; Colorectal Neoplasms; Pancreatic Neoplasms; Esophageal Neoplasms; Breast Neoplasms; Uterine Cervical Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Urinary Bladder Neoplasms; Prostatic Neoplasms; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Liver Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Head and Neck Neoplasms; Esophageal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Urologic Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Zhixi Su, PHD

CONTACT

+862180113170; zhixi.su@singlera.com

Rui Liu

CONTACT

+862180113170; rliu@singlera.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: July 20, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: February 21, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)