Condition or disease | Intervention/treatment |
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Acute Myeloid Leukemia | Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis |
PRIMARY OBJECTIVES:
I. Characterize the T cell receptor (TCR) repertoire in acute myeloid leukemia (AML) patients before and after receiving hematologic stem cell transplantation (HSCT).
II. Identify molecular changes (germline variants and somatic mutations) that contribute to shaping the TCR repertoire.
OUTLINE:
Patents undergo collection of blood samples before, on day 100, and 1 year after HSCT. Donors undergo collection of blood at the time of HSCT for ribonucleic acid (RNA)-based next generation sequencing of TCRA and TCRB genes.
Study Type : | Observational |
Estimated Enrollment : | 200 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Characterization of T-cell Repertoire in Patients With AML Undergoing HSCT Through Next-Generation Sequencing of T Cell Receptor Alpha (TCRA) and T Cell Receptor Beta (TCRB) Genes |
Actual Study Start Date : | April 12, 2018 |
Estimated Primary Completion Date : | February 1, 2022 |
Estimated Study Completion Date : | February 1, 2023 |
Group/Cohort | Intervention/treatment |
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Ancillary-correlative (next generation sequencing)
Patents undergo collection of blood samples before, on day 100, and 1 year after HSCT. Donors undergo collection of blood at the time of HSCT for RNA-based next generation sequencing of TCRA and TCRB genes.
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Procedure: Biospecimen Collection
Undergo collection of blood samples
Other: Laboratory Biomarker Analysis Correlative studies
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christine Duran | 323-865-0371 | Duran_C@med.usc.edu |
United States, California | |
USC / Norris Comprehensive Cancer Center | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Houda Alachkar 323-442-2696 alachkar@usc.edu | |
Principal Investigator: Houda Alachkar |
Principal Investigator: | Houda Alachkar, PharmD, PhD | University of Southern California |
Tracking Information | |||||||
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First Submitted Date | April 16, 2019 | ||||||
First Posted Date | April 19, 2019 | ||||||
Last Update Posted Date | May 14, 2019 | ||||||
Actual Study Start Date | April 12, 2018 | ||||||
Estimated Primary Completion Date | February 1, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures | Not Provided | ||||||
Original Secondary Outcome Measures | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | Characterization of T-cell Repertoire in Patients With Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant | ||||||
Official Title | Characterization of T-cell Repertoire in Patients With AML Undergoing HSCT Through Next-Generation Sequencing of T Cell Receptor Alpha (TCRA) and T Cell Receptor Beta (TCRB) Genes | ||||||
Brief Summary | This research trial studies characterization of T-cell repertoire through next-generation sequencing in patients with acute myeloid leukemia undergoing stem cell transplant. Characterizing T-cell repertoire may help to understand if immune system plays a significant role in high risk patients with acute myeloid leukemia. | ||||||
Detailed Description |
PRIMARY OBJECTIVES: I. Characterize the T cell receptor (TCR) repertoire in acute myeloid leukemia (AML) patients before and after receiving hematologic stem cell transplantation (HSCT). II. Identify molecular changes (germline variants and somatic mutations) that contribute to shaping the TCR repertoire. OUTLINE: Patents undergo collection of blood samples before, on day 100, and 1 year after HSCT. Donors undergo collection of blood at the time of HSCT for ribonucleic acid (RNA)-based next generation sequencing of TCRA and TCRB genes. |
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Study Type | Observational | ||||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Retention: Samples With DNA Description:
Blood
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Sampling Method | Non-Probability Sample | ||||||
Study Population | Patients with AML scheduled to undergo HSCT | ||||||
Condition | Acute Myeloid Leukemia | ||||||
Intervention |
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Study Groups/Cohorts | Ancillary-correlative (next generation sequencing)
Patents undergo collection of blood samples before, on day 100, and 1 year after HSCT. Donors undergo collection of blood at the time of HSCT for RNA-based next generation sequencing of TCRA and TCRB genes.
Interventions:
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Recruiting | ||||||
Estimated Enrollment |
200 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | February 1, 2023 | ||||||
Estimated Primary Completion Date | February 1, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts |
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Listed Location Countries | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT03921047 | ||||||
Other Study ID Numbers | 9L-16-10 NCI-2017-02440 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 9L-16-10 ( Other Identifier: USC / Norris Comprehensive Cancer Center ) P30CA014089 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||||
Responsible Party | University of Southern California | ||||||
Study Sponsor | University of Southern California | ||||||
Collaborators | National Cancer Institute (NCI) | ||||||
Investigators |
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PRS Account | University of Southern California | ||||||
Verification Date | May 2019 |