Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy ((ANSWer))
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|ClinicalTrials.gov Identifier: NCT04014764|
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : July 19, 2019
|Condition or disease||Intervention/treatment|
|Acute Myelogenous Leukemia Multiple Myeloma Myelodysplastic Syndromes Lymphoma Acute Lymphoblastic Leukemia Chronic Myelogenous Leukemia Myeloproliferative Neoplasm||Other: This is a non-interventional study|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||An Observational Study to Collect and Assess Tissue Samples From Subjects With One of Three Neoplastic Conditions (ANSWer)|
|Estimated Study Start Date :||August 2019|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2023|
Documented hematologic malignancy in need of starting an active anti-cancer therapy.
This is a non-interventional study.
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.
- Clinical response to treatment [ Time Frame: 3 years ]Collect clinical responses to treatment and outcomes in patients who have provided samples to the biobank
- Type of clinical treatment responses [ Time Frame: 3 years ]Correlate ex vivo drug sensitivity data on patient samples with clinical treatment responses.
- Types of somatic tumor mutations [ Time Frame: 3 years ]Determine genotype and/or phenotype relationships between ex vivo and clinical responses with somatic tumor mutations.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014764
|Contact: Donna M Stram||9783400869||DONNA@CHIMERACLINICAL.COM|
|Contact: Susanna Wen|
|Principal Investigator:||Hiroomi Tada, MD, Ph.D.||Notable Labs|