Clinical trial · Observational
PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale Cancers, PERCEIVE-I
Gynecologic Malignancies Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Prospective, Observational Study
NCT04903665CI-TRIAL-00059936unknownClinicalTrials.gov clinicaltrialsProvenance
- 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 study is a prospective study aimed to develop and validate the performance of combined multi-omitcs assays for early detection of gynecologic cancers. Biomarkers of cfDNA methylation, ctDNA mutation and blood miRNA markers will be evaluated. The study will enroll approximately 495 female participants, including participants with gynecologic cancers or benign diseases.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-cancer early detection test | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cancer Arm
- description
- Participants with new diagnosis of gynecologic cancers, from whom blood samples will be collected.
- interventionNames
- Device: Multi-cancer early detection test
- label
- Benign Arm
- description
- Participants with new diagnosis of benign gynecologic diseases, from whom blood samples will be collected.
- interventionNames
- Device: Multi-cancer early detection test
Primary outcomes (1)
- measure
- Sensitivity,specificity and tissue of origin accuracy of the multi-omics model as early detection for gynecologic cancers.
- timeFrame
- 12 months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for Cancer Arm Participants: * Age 18 years or older * Able to provide a written informed consent * Confirmed diagnosis or highly suspicious cases of gynecologic malignancies * No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw Exclusion Criteria for Cancer Arm Participants: * Pregnancy or lactating women * Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant * Recipients of blood transfusion within 7 days prior to study blood draw * Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer Inclusion Criteria for Benign Arm Participants: * Age 18 years or older * Able to provide a written informed consent * Confirmed diagnosis of benign gynecologic diseases * No prior radical treatment of the benign diseases prior to study blood draw Exclusion Criteria for Benign Arm Participants: * Pregnancy or lactating women * Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant * Recipients of blood transfusion within 7 days prior to study blood draw * Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer
References
Publications (0)
Data not yet available
No reference posted for this study.