AzTrials
AzTrials

Anemia, Sickle CellNCT02843347

STRIDE Biorepository

An observational study of Anemia, Sickle Cell, run by Emory University at 40 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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)". Read more about this study

Who is it for?
Ages 15 to 40 years
Conditions the study is for
Anemia, Sickle Cell
What is being tested?
Blood draw
Type of treatment
Surgery or procedure
How many people
200 participants
Where
40 sitesUnited States
Study dates
13 Mar 2017to Jul 2023
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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:
  • Clinically significant neurologic event (stroke) or any neurological deficit lasting > 24 hours;
  • 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);
  • 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);
  • 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);
Show all 14Show fewer
  • An echocardiographic finding of tricuspid valve regurgitant jet (TRJ) velocity ≥ 2.7 m/sec;
  • 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:
  • Karnofsky/Lansky performance score > or equal to 60
  • Cardiac function: Left ventricular ejection fraction (LVEF) > 40%; or LV shortening fraction > 26% by cardiac echocardiogram or by Multi Gated Acquisition (MUGA) Scan
  • 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)
  • 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)
  • 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.

Who cannot join

  • 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).
Show all 17Show fewer
  • 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

Trial locations and contacts

40 sites in 1 country.

Lakshmanan Krishnamurti, MD contact

404-785-1112

lakshmanan.krishnamurti@emory.edu

40 sites in 1 country

United States40 sites, 40 recruiting

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48105

    Greg Yanik, gyanik@med.umich.edu

    Recruiting

  • Grady Hospital

    Atlanta, Georgia, 30303

    Fuad El Rassi, fuad.elrassi@emory.edu

    Recruiting

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322

    Lakshmanan Krishnamurti, MD, 404-785-1441, lakshmanan.krishnamurti@emory.edu

    Recruiting

  • Emory Children's Center

    Atlanta, Georgia, 30322

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Edmund Waller, ewaller@emory.edu

    Recruiting

  • Augusta University Medical Center

    Augusta, Georgia, 30912

    Jeremy Pantin, JPANTIN@gru.edu

    Recruiting

  • Dana Farber Cancer Institute/Brigham and Women's Hospital

    Boston, Massachusetts, 02214

    Zachariah Defilipp, zdefilipp@mgh.harvard.edu

    Not yet recruiting

  • Boston University

    Boston, Massachusetts, 02215

    Elizabeth Klings, klingon@bu.edu

    Not yet recruiting

  • Dana Farber Cancer Institute/Massachusetts General Hospital

    Boston, Massachusetts, 02215

    Joseph Antin, jantin@partners.org

    Not yet recruiting

  • New York Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

    Ayanna Baptiste, amb9075@nyp.org

    Recruiting

  • University of North Carolina Hospital at Chapel Hill

    Chapel Hill, North Carolina, 27516

    Kimberly Kasow, kimberly_kasow@med.unc.edu

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29435

    Jennifer Jaroscak, jaroscak@musc.edu

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22908

    Tamila Kindwall-Keller, TLK5DE@hscmail.mcc.virginia.edu

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    John Cunningham, jcunning@peds.bsd.uchicago.edu

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Steven Devine, steven.devine@osumc.edu

    Recruiting

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Paul Swerdlow, swerdlow@karmanos.org

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27705

    Keith Sullivan, keith.sullivan@duke.edu

    Recruiting

  • University of Florida Gainsville

    Gainesville, Florida, 32611

    Paul Castillo, castillopa@ufl.edu

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Jennifer Krajewski, JKrajewski@HackensackUMC.org

    Recruiting

  • Foundation for Sickle Cell Research/Florida Sickle Inc.

    Hollywood, Florida, 33021

    Gershwin Blyden, GBlyden@fscdr.org

    Not yet recruiting

  • University of Texas Health Sciences Center

    Houston, Texas, 77004

    Harinder Juneja, harinder.s.juneja@uth.tmc.edu

    Recruiting

  • Baylor College of Medicine/The Methodist Hospital

    Houston, Texas, 77030

    Premal Lulla, lulla@bcm.edu

    Recruiting

  • University of Texas/MD Anderson CRC

    Houston, Texas, 77030

    Uday Popat, upopat@mdanderson.org

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Arunkumar Modi, Arunkumar-modi@uiowa.edu

    Recruiting

  • University of Miami

    Miami, Florida, 33136

    Lazaros Lekakis, LLekakis@med.miami.edu

    Recruiting

  • Cohen Children's Medical Center

    New Hyde Park, New York, 11040

    Indira Sahdev, ISahdev@northwell.edu

    Not yet recruiting

  • Children's Hospital of New Orleans

    New Orleans, Louisiana, 70118

    Lolie Yu, lyu@lsuhsc.edu

    Recruiting

  • Oschner Medical Center

    New Orleans, Louisiana, 70121

    Andrew Dalovisio, andrew.dalovisio@ochsner.org

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    John Levine

    Recruiting

  • Weill Cornell Medical College

    New York, New York, 10065

    Tsiporah Shore, Tbs2001@med.cornell.edu

    Recruiting

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

    Alice J Cohen, acohen@barnabashealth.org

    Recruiting

  • Benioff Children's Hospital at Oakland

    Oakland, California, 94609

    Mark Walters, MWalters@mail.cho.org

    Recruiting

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

    George Selby, George-Selby@ouhsc.edu

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Tim Olsen, olsont@email.chop.edu

    Recruiting

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

    Beth Carella, beth.carella@chp.edu

    Recruiting

  • Oregon Health Sciences University

    Portland, Oregon, 97239

    Trisha Wong, wong@ohsu.edu

    Not yet recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

    Christina Wiedl, cwiedl@vcu.edu

    Recruiting

  • Washington University/St. Louis Children's Hospital

    St Louis, Missouri, 63110

    Mark Schroeder, markschroeder@wustl.edu

    Recruiting

  • Montefiore Medical Center/Albert Einstein School of Medicine

    The Bronx, New York, 10467

    Murali Janakiram, mjanakir06@gmail.com

    Recruiting

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

    Allistair Abraham, AAbraham@childrensnational.org

    Recruiting

Other trials in United States

About this study

Official title: 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)".

Read the 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.

Being tested
Blood draw
Keywords
Biorepository, Genetics
Medical subject headings
Anemia, Sickle Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood drawProcedure or surgery

    Three tubes of blood (28.5 mL in total) will be obtained at the Baseline Visit. The sample will be stored for future research.

Study groups in NCT02843347
Study groupRoleWhat they receive
Biorepository substudy participantsParticipants from the main study who give consent for the genetic testing substudy.
Receives: Procedure: Blood draw

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Genetic variants in persons with sickle cell disease

    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.

    Measured: Baseline Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2016 (estimated)
  2. Study start13 Mar 2017
  3. Primary completionJul 2023 (estimated)
  4. Study completionJul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02843347
Sponsor's protocol ID
IRB00089102
Other IDs
1U01HL128566
Status last verified
Feb 2021
First submitted
8 Jul 2016
Last updated
8 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Anemia, Sickle Cell, run by Emory University at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lakshmanan Krishnamurti, MD (404-785-1112, lakshmanan.krishnamurti@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Genetic variants in persons with sickle cell disease (time frame: Baseline Visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02843347.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in