STRIDE Biorepository

February 5, 2021 updated by: Lakshmanan Krishnamurti, Emory University

1503 BMT CTN STRIDE Biorepository

The STRIDE Biorepository is an optional substudy available to participants in "Bone Marrow Transplantation vs Standard of Care in Patients with Severe Sickle Cell Disease (BMT CTN 1503) (STRIDE)".

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A subset of sites for the main study "Bone Marrow Transplantation vs Standard of Care in Patients with Severe Sickle Cell Disease (BMT CTN 1503) (STRIDE)" (NCT02766465) will also participate in the biorepository portion of the study. The purpose of the biorepository is to examine DNA to learn if certain genes predict who will have serious complications of sickle cell disease. The STRIDE Biorepository is an optional substudy available to individuals enrolled in the main study, who are at a participating site. Participants in the main study who consent to take part in the biorepository will have blood drawn at the Baseline Visit. This blood will be shipped to Emory University in Atlanta Georgia and stored for future research.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94609
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Gainesville, Florida, United States, 32611
        • Recruiting
        • University of Florida Gainsville
        • Contact:
      • Hollywood, Florida, United States, 33021
        • Not yet recruiting
        • Foundation for Sickle Cell Research/Florida Sickle Inc.
        • Contact:
      • Miami, Florida, United States, 33136
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory Children's Center
      • Atlanta, Georgia, United States, 30303
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
      • Atlanta, Georgia, United States, 30322
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University Medical Center
        • Contact:
    • Illinois
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
      • New Orleans, Louisiana, United States, 70118
        • Recruiting
        • Children's Hospital of New Orleans
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Boston University
        • Contact:
      • Boston, Massachusetts, United States, 02214
        • Not yet recruiting
        • Dana Farber Cancer Institute/Brigham and Women's Hospital
        • Contact:
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Dana Farber Cancer Institute/Massachusetts General Hospital
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
      • Detroit, Michigan, United States, 48201
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University/St. Louis Children's Hospital
        • Contact:
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
      • Newark, New Jersey, United States, 07112
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center/Albert Einstein School of Medicine
        • Contact:
      • Brooklyn, New York, United States, 11215
        • Recruiting
        • New York Presbyterian Brooklyn Methodist Hospital
        • Contact:
      • New Hyde Park, New York, United States, 11040
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
          • John Levine
      • New York, New York, United States, 10065
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
      • Durham, North Carolina, United States, 27705
    • Ohio
      • Columbus, Ohio, United States, 43210
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Oregon
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Oregon Health Sciences University
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15224
    • South Carolina
      • Charleston, South Carolina, United States, 29435
        • Recruiting
        • Medical University of South Carolina
        • Contact:
    • Texas
      • Houston, Texas, United States, 77004
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine/The Methodist Hospital
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas/MD Anderson CRC
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The biorepository will consist of research participants from the main study who consent to having extra blood drawn and stored for the purpose of future genetic testing.

Description

Inclusion Criteria:

  • Age at least 15 years old to less than 41 years old

  • Severe sickle cell disease [any clinically significant sickle genotype, for example, Hemoglobin SS (Hb SS), Hemoglobin SC (Hb SC) or Hemoglobin SBeta thalassemia (Hb Sβ), or Hemoglobin S-OArab genotype] with at least 1 of the following manifestations:

    1. Clinically significant neurologic event (stroke) or any neurological deficit lasting > 24 hours;
    2. History of two or more episodes of acute chest syndrome (ACS) in the 2-year period preceding enrollment despite the institution of supportive care measures (i.e. asthma therapy);
    3. An average of three or more pain crises per year in the 2-year period preceding enrollment or referral (required intravenous pain management in the outpatient or inpatient hospital setting);
    4. Administration of regular red blood cell (RBC) transfusion therapy, defined as receiving 8 or more transfusions per year(in the 12 months before enrollment to prevent vaso-occlusive clinical complications (i.e. pain, stroke, and acute chest syndrome);
    5. An echocardiographic finding of tricuspid valve regurgitant jet (TRJ) velocity ≥ 2.7 m/sec;
    6. Ongoing high impact chronic pain on a majority of days per month for at least 6 months.

  • Adequate physical function as measured by all of the following:

    1. Karnofsky/Lansky performance score > or equal to 60
    2. Cardiac function: Left ventricular ejection fraction (LVEF) > 40%; or LV shortening fraction > 26% by cardiac echocardiogram or by Multi Gated Acquisition (MUGA) Scan
    3. Pulmonary function: Pulse oximetry with a baseline O2 saturation of ≥ 85% and diffusing capacity of the lung for carbon monoxide (DLCO) > 40% (corrected for hemoglobin)
    4. Renal function: Serum creatinine ≤ 1.5 x the upper limit of normal for age as per local laboratory and creatinine clearance >70 mL/min; or GFR > 70 mL/min/1.73 m2 by radionuclide Glomerular Filtration Rate (GFR)
    5. Hepatic function: Serum conjugated (direct) bilirubin < 2x upper limit of normal for age as per local laboratory; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 times upper limit of normal as per local laboratory.

Exclusion Criteria:

  • Human Leukocyte Antigen (HLA) typing prior to referral (consultation with hematopoietic cell transplantation (HCT) physician). However, if a subject has had HLA typing with accompanying documentation that relatives were not HLA typed and that a search of the unrelated donor registry was not performed the subject will be considered eligible. Documentation will be reviewed and adjudicated by the Protocol Officer or his/her designee.
  • Uncontrolled bacterial, viral or fungal infection in the 6 weeks before enrollment.
  • Seropositivity for HIV
  • Previous HCT or solid organ transplant
  • Participation in a clinical trial in which the patient received an investigational drug or device must be discontinued at enrollment.
  • A history of substance abuse as defined by version IV of the Diagnostic & Statistical Manual of Mental Disorders (DSM IV).
  • Demonstrated lack of compliance with prior medical care (determined by referring physician).
  • Pregnant or breast feeding females.
  • Inability to receive HCT due to alloimmunization, defined as the inability to receive packed red blood cell (pRBC) transfusion therapy.

Additional Eligibility Criteria for Transplant after Biologic Assignment to the Donor Arm:

Participants assigned to the Donor Arm at the time of biologic assignment are subject to additional transplant eligibility criteria as specified below. Additional, repeat clinical assessments prior to transplant should be obtained in accordance with institutional policies and standards of care in the interest of good clinical practice.

  • Participants must have liver magnetic resonance imaging (MRI) (at least 90 days prior to initiation of transplant conditioning) to document hepatic iron content is required for participants who are currently receiving ≥8 packed red blood cell transfusions for ≥1 year or have received ≥20 packed red blood cell transfusions (cumulative). Participants who have hepatic iron content ≥7 mg Fe/g liver dry weight by liver MRI must have a liver biopsy and histological examination/documentation of the absence of cirrhosis, bridging fibrosis, and active hepatitis (at least 90 days prior to initiation of transplant conditioning).
  • Cerebral MRI/magnetic resonance angiogram (MRA) within 30 days prior to initiation of transplant conditioning. If there is clinical or radiologic evidence of a recent neurologic event (such as stroke or transient ischemic attack) subjects will be deferred for at least 6 months with repeat cerebral MRI/MRA to ensure stabilization of the neurologic event prior to proceeding to transplantation.
  • Documentation of participant's willingness to use approved contraception method until discontinuation of all immunosuppressive medications. This is to be documented in the medical record corresponding with the consent conference.
  • Have a suitably matched HLA donor
  • Willing and able to donate bone marrow
  • Absence of anti-donor HLA antibodies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Biorepository substudy participants
Participants from the main study who give consent for the genetic testing substudy.
Procedure: Blood draw
Three tubes of blood (28.5 mL in total) will be obtained at the Baseline Visit. The sample will be stored for future research.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic variants in persons with sickle cell disease
Time Frame: Baseline Visit
A biorepository will be established for future genetic research of sickle cell disease. Blood samples will be drawn from participants at the Baseline Visit and will be stored until analyzed. Analysis will include learning more about the genetics behind complications of sickle cell disease.
Baseline Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 13, 2017

Primary Completion (ANTICIPATED)

July 1, 2023

Study Completion (ANTICIPATED)

July 1, 2023

Study Registration Dates

First Submitted

July 8, 2016

First Submitted That Met QC Criteria

July 21, 2016

First Posted (ESTIMATE)

July 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 5, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00089102
  • 1U01HL128566 (NIH)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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