Normal and Diseased Tissue and Body Fluids SamplesNCT01354002
Protocol for Collecting, Banking and Distributing Human Tissue Samples: St. Jude Children's Research Hospital Tissue Resources Core Facility
An observational study of Normal and Diseased Tissue and Body Fluids Samples, run by St. Jude Children's Research Hospital at 14 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Normal and Diseased Tissue and Body Fluids Samples
- How many people
- 100,000 participants
- Where
- 14 sitesUnited States
- Study dates
- 1 Sep 2009to Dec 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients, their relatives, and control populations treated at St. Jude Children's Research Hospital (SJCRH), collaborating sites and affiliates.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 13 recruiting
- Recruiting
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
Jeffrey Deyo, MD, 225-763-6337
Jeffrey Deyo, MD
- Recruiting
St. Jude Affiliate Clinic at Novant Health Hemby Children's Hospital
Charlotte, North Carolina, 28204
Christine Bolen, MD, 704-384-1900, Cybolen@novanthealth.org
Christine Bolen, MD
- Suspended
Children's Hospital of Michigan
Detroit, Michigan, 48201
- Recruiting
Cook Children's Medical Center
Fort Worth, Texas, 76104
Kenneth M. Heym, MD, 682-885-4007
Kenneth M. Heym, MD
- Recruiting
St. Jude Clinic at Huntsville Hospital for Women & Children
Huntsville, Alabama, 35801
Marla Daves, MD, 256-265-5833, Marla.Daves@hhsys.org
Marla Daves, MD
- Recruiting
Johnson City Medical Center
Johnson City, Tennessee, 37604
Marcela Popescu, MD, 423-431-3950
Marcela Popescu, MD
- Recruiting
LeBonheur Children's Hospital
Memphis, Tennessee, 38103
Charles Mullighan, MBBS, MD, 901-287-5437
Charles Mullighan, MBBS, MD
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Charles Mulligan, MBBS, MD, 888-226-4343, referralinfo@stjude.org
Charles Mullighan, MBBS, MD
- Recruiting
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94305
Norman J. Lacayo, MD, 650-723-5535, lacayon@stanford.edu
Norman J. Lacayo, MD
- Recruiting
Children's Hospital of Illinois at OSF-Saint Francis Medical Center
Peoria, Illinois, 61637
Mary Beth Ross, MD, 309-624-4945
Mary Beth Ross, MD
- Recruiting
Rady Children's Hospital and Health Center
San Diego, California, 92123
Deborah Schiff, MD, 858-966-5983
Deborah Schiff, MD
- Recruiting
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71130-3932
Ayobami Olanrewaju, MBBS, 318-626-0772, Ayobami.Olanrewaju@lsuhs.edu
Ayobami Olanrewaju, MBBS
- Recruiting
Mercy Children's Hospital - Springfield
Springfield, Missouri, 65804
Francisca R. Fasipe, MD, 877-700-2110
Francisca R. Fasipe, MD
- Recruiting
St. Jude Affiliate Clinic at Saint Francis Children's Hospital
Tulsa, Oklahoma, 74136
Ashraf Mohamed, MD, MHA, PhD, 918-851-1924, AmMohamed@saintfrancis.com
Ashraf Mohamed, MD, MHA, PhD
About this study
Official title: TBANK: Protocol for Collecting, Banking and Distributing Human Tissue Samples: St. Jude Children's Research Hospital Tissue Resources Core Facility
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.
Read the 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.
- Keywords
- human biological samples, tissue banking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Protocol Participants | All participants enrolled on protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collecting, processing and archiving human tissue
Human tissue and body fluids will be collected for use in research; The processing of samples helps to reduce duplication of technical effort, equipment, supplies, and laboratory space by investigators requiring human tissues for research
Measured: Samples will be stored indefinitely.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study start1 Sep 2009
- Primary completionDec 2050 (estimated)
- Study completionDec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Normal and Diseased Tissue and Body Fluids SamplesStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Mullighan, MBBS, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354002
- Sponsor's protocol ID
- TBANK
- Status last verified
- Apr 2026
- First submitted
- 9 May 2011
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31604778
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TBANK: Protocol for Collecting, Banking and Distributing Human Tissue Samples: St. Jude Children's Research Hospital Tissue Resources Core Facility
- ClinicalTrials.gov ID
- NCT01354002
- Acronym / sponsor ID
- TBANK
- Keywords
- human biological samples, tissue banking
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2009 (actual)
- Primary completion
- Dec 2050 (estimated)
- Study completion
- Dec 2050 (estimated)
- First posted
- 16 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Protocol Participants | – | –All participants enrolled on protocols |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients, their relatives, and control populations treated at St. Jude Children's Research Hospital (SJCRH), collaborating sites and affiliates.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collecting, processing and archiving human tissue
Time frame: Samples will be stored indefinitely.
Human tissue and body fluids will be collected for use in research; The processing of samples helps to reduce duplication of technical effort, equipment, supplies, and laboratory space by investigators requiring human tissues for research
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 31604778Maciaszek 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.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles Mullighan, MBBS, MD principal investigator
St. Jude Children's Research Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal and Diseased Tissue and Body Fluids Samples, run by St. Jude Children's Research Hospital at 14 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Mullighan, MBBS, MD (901-595-3387, charles.mullighan@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collecting, processing and archiving human tissue (time frame: Samples will be stored indefinitely.). 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 NCT01354002, which also lists 1 linked publication.
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 29 Apr 2026.