Clinical trial · Observational
Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing
Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing - Ascertaining Serial Cancer Patients to Enable New Diagnostic
- 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 is a prospective, observational study of 1,000 subjects with known or suspected cancer and 2,000 subjects with no known cancer. Potential participants will be asked questions to confirm their eligibility by a nurse navigator, study staff member, or physician. Informed consent will be carried out for eligible subjects in accordance with applicable federal regulations and International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines. Subjects will then complete a survey, and study staff will draw 60 mL of blood and measure the height and weight of the subject. Where available, data from the medical records of the cancer subjects will reviewed and collected. In addition, non-cancer subjects will be requested to allow access to their medical records as an optional portion of their informed consent.
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 |
|---|---|---|---|
| Early Cancer Detection | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cancer Cohort
- description
- Subjects interested in the cancer cohort, will sign an informed consent, complete an optional survey, and have 60mLs of blood draw by a licensed phlebotomist.
- label
- Non-Cancer Cohort
- description
- Subjects interested in the non-cancer cohort, will sign an informed consent, complete an optional survey, and have 60mLs of blood draw by a licensed phlebotomist.
Primary outcomes (1)
- measure
- Study Data and Samples Were Used for CancerSEEK Assay Development
- timeFrame
- 6 months
- description
- The primary objective of the study is to collect blood samples from known cancer and non cancer participants. These blood samples were used to calibrate the CancerSEEK assay. There was no pre-defined performance threshold.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Age 50 or greater * Ability to understand the nature of this study and give written informed consent CANCER COHORT: Either of the following: * Histologic diagnosis of cancer with no prior systemic or definitive therapy (any stage, including, inclusive of is-situ carcinoma) Or * Subject with high suspicion of cancer through radiological and/or clinical assessment who are scheduled for resection or biopsy within 6 weeks of study blood collection and have not received prior systemic or definitive therapy. NON-CANCER COHORT * No prior history of cancer Exclusion Criteria: ALL PATIENTS * Evidence of active febrile infection prior to blood draw. * Women who are pregnant or breast-feeding. * History of an allogeneic bone marrow, stem cell transplant, or solid organ transplant. * Judgment by the Investigator or study staff of any other reason that would prohibit the inclusion of the subject in the study. CANCER COHORT * Subjects newly diagnosed with a hematologic malignancy, primary central nervous system tumor, prostate cancer, or skin cancer (including melanoma). * History of, or currently receiving, systemic or definitive cancer treatment including curative surgical resection, chemotherapy, radiation therapy, immunotherapy, and hormone therapy. NON-CANCER COHORT • None
References
Publications (2)
- DERIVEDMayerhoefer ME, Kienzle A, Woo S, Vargas HA. Update on Liquid Biopsy. Radiology. 2025 Jun;315(3):e241030. doi: 10.1148/radiol.241030. PMID 40525978
- DERIVEDPost C, Braun TP, Etzioni R, Nabavizadeh N. Multicancer Early Detection Tests: An Overview of Early Results From Prospective Clinical Studies and Opportunities for Oncologists. JCO Oncol Pract. 2023 Dec;19(12):1111-1115. doi: 10.1200/OP.23.00260. Epub 2023 Oct 18. PMID 37851937