Trial Title:
A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia
NCT ID:
NCT05702645
Condition:
B Acute Lymphoblastic Leukemia Associated With Down Syndrome
Down Syndrome
Myeloid Leukemia Associated With Down Syndrome
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Down Syndrome
Syndrome
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Patients undergo saliva/buccal and blood sample collection
Arm group label:
Observational (biospecimen collection, clinical evaluation)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Clinical Evaluation
Description:
Undergo a clinical assessment
Arm group label:
Observational (biospecimen collection, clinical evaluation)
Other name:
Clinical Assessment
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Observational (biospecimen collection, clinical evaluation)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Observational (biospecimen collection, clinical evaluation)
Summary:
This study attempts to learn more about the health of persons with Down syndrome after
treatment for acute leukemia. Children with Down syndrome are at increased risk for side
effects during treatment for acute leukemia, but it is unclear of their risk for
long-term effects of cancer treatment. By learning more about the factors that may
contribute to chronic health conditions and long-term effects after treatment for
leukemia in persons with Down syndrome, clinical practice guidelines for survivorship
care can be developed to help improve their quality-of-life.
Detailed description:
PRIMARY OBJECTIVE:
I. To determine the prevalence, type, and severity of chronic health conditions (CHC) in
survivors of Down syndrome-associated acute leukemia (DS-AL), and to compare CHC with
frequency-matched DS individuals that have no cancer history.
SECONDARY OBJECTIVES:
I. To characterize post-treatment clinical outcomes of DS-AL by prospective, in-person
assessment.
II. To determine the prevalence and severity of parent-reported neuropsychological (NP)
in survivors of DS-AL, compared with frequency-matched DS individuals with no cancer
history.
III. To determine health-related quality of life (HRQOL) in survivors of DS-AL, compared
with frequency-matched DS individuals with no cancer history.
IV. To identify clinical risk determinants of CHC, NP, and clinical outcomes in survivors
of DS-AL.
V. To establish a well-annotated cohort of survivors of DS-AL and associated biobank as a
resource for future investigations.
EXPLORATORY OBJECTIVES:
I. For DS-acute lymphoblastic leukemia (DS-ALL), test if structural birth defects and
genetic associations with etiology extend to CHC.
II. For DS-ALL, test if telomere length determined by polygenic risk score and telomere
flow-fluorescence in situ hybridization (FISH) are associated with outcomes from
in-person NP assessment.
OUTLINE:
Patients undergo an optional saliva/buccal swab in part 1 and clinical assessment in part
2 of the study. Patients may then undergo blood sample collection in part 3 of the study.
Criteria for eligibility:
Study pop:
DS-AL survivors from the Children's Oncology Group (COG) Registry and Epidemiology
protocols or locally from participating institutions.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients age >= 6 and < 40 years at the time of enrollment
- A diagnosis of Down syndrome is required, and may include any of the three
recognized types: trisomy 21 resulting from chromosomal nondisjunction (most
common), translocation (the patient has 46 chromosomes, but all or part of an
additional copy of chromosome 21 is attached to another chromosome), or mosaicism
(trisomy 21 that is present in only a fraction of cells)
- All patients must be DS-AL survivors (acute lymphoblastic leukemia [ALL] or acute
myeloid leukemia [AML])
- Note: Myeloid leukemia of Down syndrome (ML-DS) would be included under AML
category above. Also note that survivors of relapsed disease are eligible, so
long as the patient otherwise meets eligibility criteria, i.e., treatment for
relapse was completed at least 36 calendar months prior to enrollment and did
not include stem cell transplant
- Patients must have been treated for ALL or AML
- Note: History of COG therapeutic trial participation is not required. As a
reminder ML-DS would be included under the AML category here above
- All cancer treatment (oral or intravenous) must have been completed at least 36
calendar months prior to enrollment
- Patients must have a life expectancy of > 1 year
- Patient and parent of subject must be either English or Spanish speaking. At least
one parent or guardian must be able to read and write in English or Spanish
- Note: Parents or guardians are responsible for completing all forms, even in
the case of subjects that are >= 18 years old
- All patients and/or their parents or legal guardians must sign a written informed
consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
Exclusion Criteria:
- Patients with history of hematopoietic stem cell transplant (HSCT) are excluded
- Note: Patients with previous chimeric antigen receptor T-cell (CAR T-cell)
therapy, and other cellular cancer therapies can participate, as long as all
other eligibility criteria are satisfied
- Patients with a history of cancers prior to their ALL or AML diagnosis are excluded.
Patients that developed a subsequent malignant neoplasm following their ALL or AML
diagnosis are also excluded
- Note: Prior history of transient abnormal myelopoiesis is allowed, but is not
sufficient for eligibility
- Patients whose parents or guardians are unable to complete the required forms are
excluded
Gender:
All
Minimum age:
6 Years
Maximum age:
39 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Valley Children's Hospital
Address:
City:
Madera
Zip:
93636
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
559-353-3000
Email:
Research@valleychildrens.org
Investigator:
Last name:
Karen S. Fernandez
Email:
Principal Investigator
Facility:
Name:
UCSF Benioff Children's Hospital Oakland
Address:
City:
Oakland
Zip:
94609
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
510-428-3264
Email:
cogbchoak@ucsf.edu
Investigator:
Last name:
Jennifer G. Michlitsch
Email:
Principal Investigator
Facility:
Name:
UCSF Medical Center-Mission Bay
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-827-3222
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Arun A. Rangaswami
Email:
Principal Investigator
Facility:
Name:
Alfred I duPont Hospital for Children
Address:
City:
Wilmington
Zip:
19803
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
302-651-5572
Email:
Allison.bruce@nemours.org
Investigator:
Last name:
Vibhuti Agarwal
Email:
Principal Investigator
Facility:
Name:
Golisano Children's Hospital of Southwest Florida
Address:
City:
Fort Myers
Zip:
33908
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
239-343-5333
Email:
molly.arnstrom@leehealth.org
Investigator:
Last name:
Emad K. Salman
Email:
Principal Investigator
Facility:
Name:
Nemours Children's Clinic-Jacksonville
Address:
City:
Jacksonville
Zip:
32207
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
302-651-5572
Email:
Allison.bruce@nemours.org
Investigator:
Last name:
Vibhuti Agarwal
Email:
Principal Investigator
Facility:
Name:
Nemours Children's Hospital
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
302-651-5572
Email:
Allison.bruce@nemours.org
Investigator:
Last name:
Vibhuti Agarwal
Email:
Principal Investigator
Facility:
Name:
Saint Joseph's Hospital/Children's Hospital-Tampa
Address:
City:
Tampa
Zip:
33607
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
813-357-0849
Email:
jennifer.manns@baycare.org
Investigator:
Last name:
Don E. Eslin
Email:
Principal Investigator
Facility:
Name:
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Address:
City:
Atlanta
Zip:
30329
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
404-785-2025
Email:
Leann.Schilling@choa.org
Investigator:
Last name:
Karen E. Effinger
Email:
Principal Investigator
Facility:
Name:
Sinai Hospital of Baltimore
Address:
City:
Baltimore
Zip:
21215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
410-601-6120
Email:
pridgely@lifebridgehealth.org
Investigator:
Last name:
Jason M. Fixler
Email:
Principal Investigator
Facility:
Name:
C S Mott Children's Hospital
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-865-1125
Investigator:
Last name:
Joshua W. Goldman
Email:
Principal Investigator
Facility:
Name:
University of Mississippi Medical Center
Address:
City:
Jackson
Zip:
39216
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
601-815-6700
Investigator:
Last name:
Betty L. Herrington
Email:
Principal Investigator
Facility:
Name:
Children's Mercy Hospitals and Clinics
Address:
City:
Kansas City
Zip:
64108
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
816-302-6808
Email:
rryan@cmh.edu
Investigator:
Last name:
Keith J. August
Email:
Principal Investigator
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Robert J. Hayashi
Email:
Principal Investigator
Facility:
Name:
Children's Hospital and Medical Center of Omaha
Address:
City:
Omaha
Zip:
68114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
402-955-3949
Investigator:
Last name:
Jill C. Beck
Email:
Principal Investigator
Facility:
Name:
University of Nebraska Medical Center
Address:
City:
Omaha
Zip:
68198
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
402-559-6941
Email:
unmcrsa@unmc.edu
Investigator:
Last name:
Jill C. Beck
Email:
Principal Investigator
Facility:
Name:
University Medical Center of Southern Nevada
Address:
City:
Las Vegas
Zip:
89102
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
702-384-0013
Email:
research@sncrf.org
Investigator:
Last name:
Alan K. Ikeda
Email:
Principal Investigator
Facility:
Name:
Sunrise Hospital and Medical Center
Address:
City:
Las Vegas
Zip:
89109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
702-384-0013
Email:
research@sncrf.org
Investigator:
Last name:
Alan K. Ikeda
Email:
Principal Investigator
Facility:
Name:
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Address:
City:
Las Vegas
Zip:
89135
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
702-384-0013
Email:
research@sncrf.org
Investigator:
Last name:
Alan K. Ikeda
Email:
Principal Investigator
Facility:
Name:
Summerlin Hospital Medical Center
Address:
City:
Las Vegas
Zip:
89144
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
702-384-0013
Email:
research@sncrf.org
Investigator:
Last name:
Alan K. Ikeda
Email:
Principal Investigator
Facility:
Name:
Renown Regional Medical Center
Address:
City:
Reno
Zip:
89502
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
702-384-0013
Email:
research@sncrf.org
Investigator:
Last name:
Alan K. Ikeda
Email:
Principal Investigator
Facility:
Name:
Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
551-996-2897
Investigator:
Last name:
Katharine R. Lange
Email:
Principal Investigator
Facility:
Name:
Albany Medical Center
Address:
City:
Albany
Zip:
12208
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
518-262-5513
Investigator:
Last name:
Lauren R. Weintraub
Email:
Principal Investigator
Facility:
Name:
Montefiore Medical Center - Moses Campus
Address:
City:
Bronx
Zip:
10467
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
718-379-6866
Email:
eskwak@montefiore.org
Investigator:
Last name:
Alice Lee
Email:
Principal Investigator
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-767-9355
Email:
askroswell@roswellpark.org
Investigator:
Last name:
Denise A. Rokitka
Email:
Principal Investigator
Facility:
Name:
Wake Forest University Health Sciences
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
336-713-6771
Investigator:
Last name:
Thomas W. McLean
Email:
Principal Investigator
Facility:
Name:
Sanford Broadway Medical Center
Address:
City:
Fargo
Zip:
58122
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
701-323-5760
Email:
OncologyClinicalTrialsFargo@sanfordhealth.org
Investigator:
Last name:
Samuel J. Milanovich
Email:
Principal Investigator
Facility:
Name:
Rainbow Babies and Childrens Hospital
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
216-844-5437
Investigator:
Last name:
Duncan S. Stearns
Email:
Principal Investigator
Facility:
Name:
Dayton Children's Hospital
Address:
City:
Dayton
Zip:
45404
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-228-4055
Investigator:
Last name:
Jordan M. Wright
Email:
Principal Investigator
Facility:
Name:
University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Public Contact
Phone:
405-271-8777
Email:
ou-clinical-trials@ouhsc.edu
Investigator:
Last name:
Rene Y. McNall-Knapp
Email:
Principal Investigator
Facility:
Name:
Oregon Health and Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-494-1080
Email:
trials@ohsu.edu
Investigator:
Last name:
Susan J. Lindemulder
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of Pittsburgh of UPMC
Address:
City:
Pittsburgh
Zip:
15224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
412-692-8570
Email:
jean.tersak@chp.edu
Investigator:
Last name:
Jean M. Tersak
Email:
Principal Investigator
Facility:
Name:
Rhode Island Hospital
Address:
City:
Providence
Zip:
02903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
401-444-1488
Investigator:
Last name:
Bradley DeNardo
Email:
Principal Investigator
Facility:
Name:
Prisma Health Richland Hospital
Address:
City:
Columbia
Zip:
29203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
864-241-6251
Investigator:
Last name:
Stuart L. Cramer
Email:
Principal Investigator
Facility:
Name:
BI-LO Charities Children's Cancer Center
Address:
City:
Greenville
Zip:
29605
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
864-241-6251
Investigator:
Last name:
Aniket Saha
Email:
Principal Investigator
Facility:
Name:
Sanford USD Medical Center - Sioux Falls
Address:
City:
Sioux Falls
Zip:
57117-5134
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
605-312-3320
Email:
OncologyClinicalTrialsSF@SanfordHealth.org
Investigator:
Last name:
Kayelyn J. Wagner
Email:
Principal Investigator
Facility:
Name:
East Tennessee Childrens Hospital
Address:
City:
Knoxville
Zip:
37916
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
865-541-8266
Investigator:
Last name:
Susan E. Spiller
Email:
Principal Investigator
Facility:
Name:
Dell Children's Medical Center of Central Texas
Address:
City:
Austin
Zip:
78723
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
512-628-1902
Email:
TXAUS-DL-SFCHemonc.research@ascension.org
Investigator:
Last name:
Shannon M. Cohn
Email:
Principal Investigator
Facility:
Name:
UT Southwestern/Simmons Cancer Center-Dallas
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
214-648-7097
Email:
canceranswerline@UTSouthwestern.edu
Investigator:
Last name:
Ksenya Shliakhtsitsava
Email:
Principal Investigator
Facility:
Name:
Cook Children's Medical Center
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
682-885-2103
Email:
CookChildrensResearch@cookchildrens.org
Investigator:
Last name:
Donald T. Beam
Email:
Principal Investigator
Facility:
Name:
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
713-798-1354
Email:
burton@bcm.edu
Investigator:
Last name:
Maria M. Gramatges
Email:
Principal Investigator
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-632-6789
Email:
askmdanderson@mdanderson.org
Investigator:
Last name:
Najat C. Daw
Email:
Principal Investigator
Facility:
Name:
University of Texas Health Science Center at San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
210-450-3800
Email:
phoresearchoffice@uthscsa.edu
Investigator:
Last name:
Shafqat Shah
Email:
Principal Investigator
Facility:
Name:
Seattle Children's Hospital
Address:
City:
Seattle
Zip:
98105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
866-987-2000
Investigator:
Last name:
Sarah E. Leary
Email:
Principal Investigator
Facility:
Name:
Providence Sacred Heart Medical Center and Children's Hospital
Address:
City:
Spokane
Zip:
99204
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-228-6618
Email:
HopeBeginsHere@providence.org
Investigator:
Last name:
Judy L. Felgenhauer
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center-Marshfield
Address:
City:
Marshfield
Zip:
54449
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-782-8581
Email:
oncology.clinical.trials@marshfieldresearch.org
Investigator:
Last name:
Jon M. Brandt
Email:
Principal Investigator
Start date:
June 12, 2023
Completion date:
December 16, 2028
Lead sponsor:
Agency:
Children's Oncology Group
Agency class:
Other
Source:
Children's Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05702645
