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出境医 / 临床实验 / Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy ((ANSWer))

Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy ((ANSWer))

Study Description
Brief 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.

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

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.

Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
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)
Actual Study Start Date : December 15, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023
Arms and Interventions
Group/Cohort Intervention/treatment
Single group

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.
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
The study will require tissue samples taken from consented subjects to be assayed using Notable's ex vivo, high-throughput flow cytometry based platform. The result of this assay will be compared to the subject's documented diagnosis as well as clinical outcome, where applicable. Additional biomarker testing, such as sequencing to determine somatic mutations using targeted panels, may also be conducted.

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 1000 Subjects with diagnosed with a hematological malignancy will be enrolled to provide at least 1000 biospecimen samples.
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Donna M Stram 9783400869 DONNA@CHIMERACLINICAL.COM
Contact: Susanna Wen

Locations
Show Show 20 study locations
Sponsors and Collaborators
Notable Labs
Investigators
Layout table for investigator information
Principal Investigator: Hiroomi Tada, MD, Ph.D. Notable Labs
Tracking Information
First Submitted Date July 3, 2019
First Posted Date July 10, 2019
Last Update Posted Date March 22, 2021
Actual Study Start Date December 15, 2019
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2019) 		Clinical response to treatment [ Time Frame: 3 years ]
Collect clinical responses to treatment and outcomes in patients who have provided samples to the biobank
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 10, 2019)
  • 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.
Original Secondary Outcome Measures
 (submitted: July 8, 2019)
  • clinical treatment responses compared to ex vivo drug sensitivity data [ Time Frame: 3 years ]
    Correlate ex vivo drug sensitivity data on patient samples with clinical treatment responses.
  • Relationship between ex vivo and clinical response and somatic tumor mutation [ Time Frame: 3 years ]
    Determine genotype and/or phenotype relationships between ex vivo and clinical responses with somatic tumor mutations.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy
Official Title An Observational Study to Collect and Assess Tissue Samples From Subjects With One of Three Neoplastic Conditions (ANSWer)
Brief 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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Retention:   Samples With DNA
Description:
The study will require tissue samples taken from consented subjects to be assayed using Notable's ex vivo, high-throughput flow cytometry based platform. The result of this assay will be compared to the subject's documented diagnosis as well as clinical outcome, where applicable. Additional biomarker testing, such as sequencing to determine somatic mutations using targeted panels, may also be conducted.
Sampling Method Non-Probability Sample
Study Population Approximately 1000 Subjects with diagnosed with a hematological malignancy will be enrolled to provide at least 1000 biospecimen samples.
Condition
  • Acute Myelogenous Leukemia
  • Multiple Myeloma
  • Myelodysplastic Syndromes
  • Lymphoma
  • Acute Lymphoblastic Leukemia
  • Chronic Myelogenous Leukemia
  • Myeloproliferative Neoplasm
Intervention 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.
Study Groups/Cohorts Single group

Documented hematologic malignancy in need of starting an active anti-cancer therapy.

This is a non-interventional study.

Intervention: Other: This is a non-interventional study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 8, 2019) 		1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2023
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Donna M Stram 9783400869 DONNA@CHIMERACLINICAL.COM
Contact: Susanna Wen
Listed Location Countries Greece,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04014764
Other Study ID Numbers N-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Notable Labs
Study Sponsor Notable Labs
Collaborators Not Provided
Investigators
Principal Investigator: Hiroomi Tada, MD, Ph.D. Notable Labs
PRS Account Notable Labs
Verification Date January 2021

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