Frequently Asked Questions
FAQs for Investigators
What kinds of studies are considered to be appropriate for using NCTN biospecimens?
Because of their value, limited availability, and the scientific review involved in the application process, NCTN biospecimens are best suited for correlative science studies that:
- seek to validate the prognostic or predictive diagnostic power of novel biomarkers;
- are performed using assay methods and reagents that have been previously analytically validated;
- require large numbers of specimens from uniformly treated and phenotypically homogeneous patient populations;
- require outcome or treatment response data to demonstrate clinical utility; or
- are supported by a statistical rationale for the number of specimens and type of clinical data needed to demonstrate clinical significance.
Examples of studies that may not be well suited for NCTN biospecimen utilization include:
- “discovery” experiments;
- assay development;
- basic biology studies or projects that do not need extensive clinical or outcome data;
- pilot studies that require “just-in-time” data generation; and
- studies requiring fresh tissue or biospecimens subjected to specialized processing or prospective collection.
Do I need to belong to an NCTN Group to request biospecimens?
No. Requests may be submitted by any qualified academic or non-academic investigator. Investigators may benefit from collaborating with NCTN Group members connected to the trials.
Do I need IRB approval to use these specimens?
Yes. You will need to submit your proposal to an Institutional Review Board (IRB)/Research Ethics Board (REB) and provide documentation that they have reviewed the submission and the outcome of the review. IRB/REB review is required even if the specimens you are receiving have had patient identifiers removed. Templates are available to help you submit your proposals. View the NCTN Banks Forms on the side of any page on this website to download these templates or ask the NCTN Group for additional materials.
Why don’t you have specimens from every patient who registered?
Many NCTN Group clinical trials have a tissue collection component. In most cases, especially in older studies, tissues were collected for clinical trial-specific correlative studies. After conducting these studies, some biospecimens may have no material left for future studies. Additionally, collection of biospecimens may or may not have been mandatory for participation in a trial, and thus, biospecimens were not collected or may be unavailable because of patient choice. Patients' choices for use of their biospecimens as well as institutional resources also may have an impact on biospecimen availability. Some examples of situations that may contribute to lack of adequate specimens include failure of a procedure to provide adequate material for both patient treatment and future study, a patient's refusal to undergo a procedure, or inability of the Group or institution to adequately fund the performance of a special procedure required to collect the material. Also, local institutional policies may affect its ability to share biospecimens.
Can these biospecimens be used for Genome-Wide Association Studies (GWAS)?
This will depend on several factors, including the policies and procedures that were/are in place for the Group(s) providing the materials for study. Relevant issues to consider are whether the patient signed a consent form that indicated future research that might include genetic testing and whether the research requires submission of data to a central database* (in some situations, particularly for older trails, the patient must have been notified of this in the consent process). Finally, if outcome data are to be supplied to a central database as a part of the research, the Group(s) may need to approve this or arrange a data sharing agreement. Because of the potential complexity of the question, it is best to consult with the Group(s) about relevant policies and the details of the specific clinical trial(s) from which the biospecimens of interest were collected. See the contacts page for group contact information.
*The NCI has issued guidelines outlining updated informed consent language that meets these criteria.
What are the criteria for approving a biospecimen request?
Criteria include feasibility and availability of biospecimens and data resources, as well as scientific and statistical rationale. A more detailed description of the request and review processes can be found on the access process page.
I only want a few biospecimens; does my proposal really require NCI review?
Yes, but note that requests requiring only a few biospecimens may not be the type of project that is appropriate for use of NCTN biospecimens (see FAQ #1 above). Please refer to the links section on the resources page where you may find other sources of biospecimens that may be better suited for your project.
How do I contact an NCTN Group to request their specimens?
The NCTN Group Bank should be contacted to inquire about available sample inventory and the needs of your study. You should also contact a representative from the NCTN Group regarding that group’s request process. Typically your first contact will give you the contact information of others relevant to your request. NCTN Group contact information is available on the contacts page.
A more detailed description of the request process is described on the access process page.
How are the NCTN Banks different from the CHTN Banks?
The NCTN Biospecimen Banks collect and distribute biospecimens in conjunction with large NCI-sponsored phase II and phase III clinical treatment trials of adult and pediatric hematologic and solid tumor malignancies. These specimens are highly annotated with medical, treatment, and outcome data
The Cooperative Human Tissue Network (CHTN) is a group of six academic institutions (five adult divisions and one pediatric division) funded by the NCI to work together (as a network) to provide remnant human tissue and fluids from routine procedures to investigators who utilize human biospecimens throughout the U.S. and elsewhere.
The CHTN provides malignant, benign, diseased, normal, and fluid biospecimens from routine surgical resections and autopsies. Unlike tissue banks, the CHTN works prospectively with each investigator to tailor specimen acquisition and processing to meet their specific project requirements. Biospecimens can be provided to the investigator fresh, frozen, or as paraffin blocks and/or slides. Although the CHTN is not a bank, some biospecimens are banked for a limited time. Banked biospecimens that meet an investigator's request will be made available for distribution. Each of the adult divisions (University of Pennsylvania, Vanderbilt University, Ohio State University, University of Alabama-Birmingham, and University of Virginia) coordinates investigator applications/requests based upon the investigator's geographic location within North America. The pediatric division (Nationwide Children’s Hospital) manages all investigators who request pediatric specimens. All CHTN divisions share coordination for requests from outside North America.
In addition to procuring and distributing biospecimens following the usual CHTN procedures, the pediatric division of the CHTN (pCHTN) also has a unique and longstanding relationship with the Children’s Oncology Group (COG). This relationship allows the pCHTN to distribute COG banked biospecimens once all clinical trial-specific correlative science studies/projects are completed. In this setting, applications for these precious clinically-annotated biospecimens are handled by the pCHTN, but biospecimen availability is determined by the COG’s specific Disease Committees following detailed evaluation of the scientific value of each application.
How long after I make my request will I receive my biospecimens?
Making a request for NCTN biospecimens does not guarantee that specimens will be distributed. Any proposed request must undergo scientific, statistical, and regulatory review before specimens are approved for distribution.
Even if a request is approved, specimens and data must be gathered, prepared, quality assured, and then distributed. The process may take several months, depending upon the size and nature of the biospecimen request. Research projects that involve request and eventual utilization of NCTN biospecimens should be planned far in advance and be commensurate with any research funding application to perform the proposed studies. NCTN biospecimens are not intended to be used for "just in time" studies that require rapid generation of preliminary data.
If I was on one of these clinical trials and consented to have my specimens donated, how can I check to make sure that it happened?
You would check with the investigator/study staff who enrolled you in the clinical trial.
The NCTN Banks do not talk to patients directly and many have strict policies that do not allow them to have direct contact with the patients who agreed to provide their biospecimens. Also, most banks receive and store biospecimens using codes that are designed so that bank staff cannot link the biospecimens directly to you. Therefore, the banks would not know whether they received biospecimens specifically from you. This coding of biospecimens is done to specifically protect your confidentiality.