Clinical trial · Observational
Specimen Collection from Patients with Non-Hematologic Cancer for Use in Development of a Liquid Biopsy Assay
Collection of Whole Blood and Tissue Specimens from Patients Diagnosed with Non-Hematologic Cancer for Use in Development of a Noninvasive Liquid Biopsy Assay to Determine the Tumor Genomic Profile in Circulating Cell-Free Tumor DNA
NCT02586389CI-TRIAL-00081662recruitingClinicalTrials.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 specimen collection is designed to obtain whole blood and tumor tissue from subjects diagnosed with cancer for the purpose of the development of a noninvasive liquid biopsy assay using next generation sequencing (NGS).
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 |
|---|---|---|---|
| Non-hematologic Cancer | Non-Hematologic Malignancy | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Non-hematological Cancer Cohort
- description
- Eligible subjects will have been previously diagnosed with a non-hematological cancer with tumor present at baseline blood draw.
Primary outcomes (1)
- measure
- biospecimen sample collection for liquid biopsy assay development
- timeFrame
- After cancer diagnosis through 5 years of standard of care follow-up visits
- description
- Analysis of circulating tumor DNA (ctDNA) in whole blood will be compared to baseline tumor DNA for concordance of mutations related to cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject is 18 years of age or older; * Subject is willing to provide written informed consent; * Subject has a diagnosis of a non-hematologic cancer, has tumor in the body, and has either; 1. residual tumor tissue available for testing by the Sponsor; or 2. genomic profiling results from an IVD or LDT assay performed on tumor biopsy tissue; or 3. an invasive procedure (biopsy, surgery) scheduled following the Baseline Visit from which residual tumor tissue can be available for testing by the Sponsor. * Subject is able, in the professional opinion of the investigator, to provide whole blood at the Baseline Visit and at the Interim Visits. Exclusion Criteria: * Underwent curative-intent surgery for management of the presently diagnosed tumor, at any time prior to the Baseline Visit. * Underwent targeted or non-targeted chemotherapy, hormone receptor blocking therapy, or radiation therapy prior to the Baseline Visit. * Underwent an invasive procedure (biopsy, surgery, thermal ablation) in the 7 days prior to any blood collection (baseline or follow-up). * Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.