RECRUITINGOBSERVATIONAL
INSPIRE: a Multi-Cancer Early Detection Study
INSPIRE: Integrating Circulating DNA Methylation and Fragmentomics to Scan and Pinpoint Cancer Signals Effectively
About This Trial
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
Who May Be Eligible (Plain English)
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 willing to sign a consent form 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 willing to sign a consent form 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Locations (1)
Fudan University
Shanghai, Shnaghai, China