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Completed

NCT Number: NCT04014764

Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy

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.

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Key information

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provide written informed consent;
  • Age ≥ 18 years, male or female, of any race;
  • Documented hematologic malignancy (any of the below) in need of starting an active anti-cancer therapy:
  • Acute myelogenous leukemia (AML)
  • Multiple myeloma (MM)
  • Myelodysplastic syndrome (MDS)
  • Lymphoma
  • Acute lymphocytic leukemia (ALL)
  • Chronic lymphocytic leukemia (CLL)
  • Chronic myelogenous leukemia (CML)
  • Neoplasm (MPN)
  • Other (upon review and approval by medical monitor)

Note: *Supportive care agents including erythropoiesis-stimulating agents (ESAs) such as EPO, Procrit, Aranesp, etc; granulocyte colony stimulating factor (G-CSF); hydroxyurea (Hydrea); and luspatercept (Reblozyl) are not considered anti-cancer therapy for this study

  • Intent to start anti-cancer therapy within 21 days of biospecimen collection

•≥7 days from last anti-cancer therapy;

  • Any number of prior therapies
  • Subject cohort is currently open

Exclusion criteria

  • Unwilling or unable to give consent
  • Subject's disease is in remission
  • Subject cohort is not open at time of consent
  • Subject is restarting an ongoing treatment regimen after a dose interruption

Treatment and study plan

This is a non-interventional study

Other

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.

Primary outcomes

  1. Clinical response to treatment

    Time frame: 3 years

    Collect clinical responses to treatment and outcomes in patients who have provided samples to the biobank

Secondary outcomes

  1. Type of clinical treatment responses

    Time frame: 3 years

    Correlate ex vivo drug sensitivity data on patient samples with clinical treatment responses.

  2. 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.

Sponsors and collaborators

Lead sponsor

Notable Labs

Industry

Registry information

Official study title

An Observational Study to Collect and Assess Tissue Samples From Subjects With One of Three Neoplastic Conditions (ANSWer)

Acronym: (ANSWer)

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 10, 2019
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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