Clinical trial NCT01354002: Protocol for Collecting, Banking and Distributing Human Tissue Samples: St. Jude Children's Research Hospital Tissue Resources Core Facility
Official title: TBANK: Protocol for Collecting, Banking and Distributing Human Tissue Samples: St. Jude Children's Research Hospital Tissue Resources Core Facility
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Normal and Diseased Tissue and Body Fluids Samples
Keywords: human biological samples
tissue banking
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2011-05-16
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients, their relatives, and control populations treated at St. Jude Children's Research Hospital (SJCRH), collaborating sites and affiliates.

Brief summary: The aims of this protocol are: to collect and store diseased and normal tissue and body fluid samples from new and returning patients at St. Jude Children's Research Hospital (SJCRH), affiliated sites and collaborating institutions; to collect and store samples from relatives of SJCRH patients; to collect and store retrospective and prospective pertinent corresponding clinical and laboratory data on disease characterization, treatment, and outcome; and to serve as a source of human biological samples and corresponding laboratory and clinical data.

Detailed description: There is no study design for this protocol. Samples obtained under IRB/IEC-approved protocols that clearly permit storage of patient material at SJCRH will be banked, provided proof of informed consent is available. Such samples will be tagged accordingly and will be only released to fulfill the aim(s) of the protocol under which they were obtained, or to investigators that apply to the St. Jude Children's Research Hospital Tissue Resources Committee to use the samples.

Eligibility criteria: Inclusion Criteria:

* Patients (and their relatives) and control populations treated or studied at SJCRH and SJCRH affiliates and collaborating sites that have IRB approval for TBANK with malignant and non-malignant conditions.
* Patients from institutions that do not have Institutional Review Board (IRB) approval for TBANK, and at which a banking mechanism may not be established, who provide samples for research at St. Jude and from whom consent for TBANK is obtained by the TBANK principal investigator (PI).
* Samples from employees of St. Jude Children's Research Hospital (SJCRH) collected for public health surveillance studies (e.g. SJTRC-NCT04362995) provided the employees have consented to participate in the specific IRB-approved studies.

Exclusion Criteria:

* Patients from institutions that do not have IRB approval for TBANK, and who have not provided consent for TBANK, or patients not enrolled on SJCRH protocols that incorporate consent for tumor banking.

Primary outcomes:
measure: Collecting, processing and archiving human tissue
timeFrame: Samples will be stored indefinitely.
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Huntsville Hospital for Women & Children
state: Alabama
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford University
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital and Health Center
state: California
city: Peoria
country: United States
facility: Children's Hospital of Illinois at OSF-Saint Francis Medical Center
state: Illinois
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Springfield
country: United States
facility: Mercy Children's Hospital - Springfield
state: Missouri
city: Charlotte
country: United States
facility: St. Jude Affiliate Clinic at Novant Health Hemby Children's Hospital
state: North Carolina
city: Tulsa
country: United States
facility: St. Francis Hospital
state: Oklahoma
city: Johnson City
country: United States
facility: Johnson City Medical Center
state: Tennessee
city: Memphis
country: United States
facility: LeBonheur Children's Hospital
state: Tennessee
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Charles Mullighan, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maciaszek JL, Oak N, Chen W, Hamilton KV, McGee RB, Nuccio R, Mostafavi R, Hines-Dowell S, Harrison L, Taylor L, Gerhardt EL, Ouma A, Edmonson MN, Patel A, Nakitandwe J, Pappo AS, Azzato EM, Shurtleff SA, Ellison DW, Downing JR, Hudson MM, Robison LL, Santana V, Newman S, Zhang J, Wang Z, Wu G, Nichols KE, Kesserwan CA. Enrichment of heterozygous germline RECQL4 loss-of-function variants in pediatric osteosarcoma. Cold Spring Harb Mol Case Stud. 2019 Oct 23;5(5):a004218. doi: 10.1101/mcs.a004218. Print 2019 Oct.