Clinical trial · Observational
INSPIRE: a Multi-Cancer Early Detection Study
INSPIRE: Integrating Circulating DNA Methylation and Fragmentomics to Scan and Pinpoint Cancer Signals Effectively
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Case arm
- description
- Participants newly diagnosed with cancer, belonging to one of thirteen distinct cancer types.
- label
- Control arm
- description
- Healthy or benign condition participants with no cancer diagnosis subsequent to routine cancer screening tests.
Primary outcomes (1)
- measure
- The AUC, sensitivity, specificity and tissue origin accuracy of the multi-cancer early detection model in detecting cancer or non-cancer
- timeFrame
- 12 months
Secondary outcomes (2)
- measure
- The performance of the multi-cancer early detection model in early stage cancer and precancerous lesion cases
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available