INSPIRE: a Multi-Cancer Early Detection Study

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

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

Conditions15

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