Tissue Procurement Protocol for the Developmental Therapeutics Clinic National Cancer Institute (NCI)
A
Anna Maria Storniolo, MD
Primary Investigator
Enrolling By Invitation
110 years and younger
All
Phase
N/A
750 participants needed
3 Locations
Brief description of study
What is the purpose of this study?
Adult patients (18 years of age and older) and pediatric patients
(younger than 18 years of age) who are being evaluated for and/or
treated for cancer at the NIH Clinical Center and at participating
sites will be entered onto this tissue procurement protocol for collection of tissue specimens.
Objectives:
Objectives:
- To obtain samples from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment.
- To obtain samples for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol.The purpose of this study is to obtain samples for research purposes from tests performed for clinical indications or research indications on other research protocols, and to obtain samples for research purposes from non-surgical procedures, performed for the sole purpose of obtaining samples for this protocol.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
This is a multicenter tissue procurement protocol with NCI as the coordinating center.
For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed on adult patients at the NIH Clinical Center for the sole purpose of obtaining tissue specimens or biological fluids. Tissues and biological fluids to be procured may include blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol.
For pediatric patients: tumor biopsy/resection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits.
Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents/guardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture.
This study has two separate consent forms at the NIH Clinical Center: one for adult patients to donate samples for ongoing research on assay development and studies of molecular pathways; and one for adult and age-appropriate pediatric patients to donate samples for the generation of preclinical models. The study also has consent form templates for adult and pediatric patients at participating sites to donate samples to create preclinical models.
Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.
For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed on adult patients at the NIH Clinical Center for the sole purpose of obtaining tissue specimens or biological fluids. Tissues and biological fluids to be procured may include blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol.
For pediatric patients: tumor biopsy/resection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits.
Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents/guardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture.
This study has two separate consent forms at the NIH Clinical Center: one for adult patients to donate samples for ongoing research on assay development and studies of molecular pathways; and one for adult and age-appropriate pediatric patients to donate samples for the generation of preclinical models. The study also has consent form templates for adult and pediatric patients at participating sites to donate samples to create preclinical models.
Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cancer, Neoplasms, Lymphoma, Multiple Myeloma
-
Age: - 110 Years
-
Gender: All
Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:
- Patients who are being evaluated for and or treated at the NIH Clinical Center or at participating sites.
- Ability to understand and willingness to sign a written informed consent document indicating their willingness to have their tissue or biologic fluid specimens used for research as outlined in this protocol.
- Age greater than 18 years
For a full list of participation criteria, please visit ClinicalTrials.gov.
Updated on
01 Aug 2024.
Study ID: 1407712395, CC06-C-0213
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