Trials / Completed
CompletedNCT04014764
Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy
An Observational Study to Collect and Assess Tissue Samples From Subjects With One of Three Neoplastic Conditions (ANSWer)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 119 (actual)
- Sponsor
- Notable Labs · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multicenter observational study to collect clinically annotated biospecimens in order to assess the correlation between ex vivo data generated by the Notable assay platform and clinical outcome.
Detailed description
This is a prospective, multicenter, observational study with collection of de-identified biospecimens with matched clinical data from up to 1000 participants from clinical networks in the United States and Canada. Clinical information, demographics, and medical data relevant to cancer status are collected from all participants and their medical record at baseline (at study entry and time of baseline biospecimen collection), and subsequent visits per patient consent, for up to 1 year. The primary assessment is the establishment of a tumor registry with annotated clinical outcomes. Exploratory assessments include correlation of ex vivo functional testing results with clinical outcomes, as well as identification of potential biomarkers that correlate responses with genotype and/or phenotype.
Conditions
- Acute Myelogenous Leukemia
- Multiple Myeloma
- Myelodysplastic Syndromes
- Lymphoma
- Acute Lymphoblastic Leukemia
- Chronic Myelogenous Leukemia
- Myeloproliferative Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | This is a non-interventional study | N/A. This is a non-interventional study. Following consent, the subject will have biospecimen samples taken during routine standard of care procedures, and provided to Sponsor for analysis. Optional research blood draws may occur at treating physician's discretion to obtain additional tissue samples. |
Timeline
- Start date
- 2019-12-15
- Primary completion
- 2022-03-31
- Completion
- 2022-03-31
- First posted
- 2019-07-10
- Last updated
- 2022-04-05
Locations
20 sites across 3 countries: United States, Greece, Spain
Source: ClinicalTrials.gov record NCT04014764. Inclusion in this directory is not an endorsement.