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Patient-Derived Models Tissue Procurement Protocol for the National Cancer Institute (NCI)


Brief Summary
This research trial collects and stores tissue and blood samples from patients with cancer. Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help scientists create new and better models to learn about cancer and to test new cancer drugs.

Detailed Description
PRIMARY OBJECTIVE: I. To procure biologic tissues and materials to generate preclinical models of cancer. OUTLINE: Tumor tissue and blood samples are procured during procedures that are required for the patients' clinical management and will be stored via xenograft (transplant to another species) models or in vitro cell culture for future analysis.



Inclusion and Exclusion Criteria

  • Patients with a histologically or cytologically confirmed diagnosis of cancer
  • Patients without histologically or cytologically confirmed diagnosis of cancer, but for whom approval has been requested and received from the coordinating site study coordinator
  • Requests for coordinating site approval should only be made if the patient's existing work-up at the time of the request demonstrates a combination of two or more of the following indicating the greater likelihood of a cancerous process in the assessment of the treating physician:
  • Radiographic imaging (computed tomography [CT], magnetic resonance imaging [MRI], etc.)
  • Elevated tumor markers
  • Clinical symptoms
  • Documented risk factors, known genetic changes (mutation, deletion, fusion, etc.), and/or known familial cancer history or syndrome
  • If the patient will be undergoing surgical resection at a later time and will be accessible to approach for study participation at that time, resected material following cancer diagnosis confirmation is preferred
  • Important: Additional medical, genetic and/or demographic work-up should not be obtained solely for determination of eligibility for protocol 9846 by these criteria. Once available, final redacted pathology confirmation must be provided to the coordinating site detailing the confirmed cancer diagnosis for patients enrolled based on the above criteria
  • Patients with a newly diagnosed primary and/or metastatic solid tumor, lymphoma or multiple myeloma malignancy for which they have not yet received treatment
  • Patients with a solid tumor, lymphoma or multiple myeloma malignancy that is recurrent, newly metastasized, or progressing while on treatment indicated by:
  • Radiographic evidence of tumor growth, re-growth, and/or new metastases, OR
  • Documentation by the treating physician of clinical disease progression
  • Patients currently undergoing treatment (adjuvant, neoadjuvant, etc.)
  • Specimen collection should occur as distant in time from the most recent drug administration as possible (e.g., after completion of a treatment cycle and immediately prior to initiation of the next cycle)
  • Specimens should not be collected from patients between doses within a single treatment cycle
  • Confirmation of viable malignancy and/or < 90% tumor necrosis must be confirmed to the National Cancer Institute (NCI) coordinating site, as indicated in the final post-operative/post-procedure pathology report
  • Patients with ongoing partial response (PR) or stable disease (SD) are eligible
  • Confirmation of viable malignancy and/or < 90% tumor necrosis must be confirmed to the coordinating site, as indicated in the final post-operative/post-procedure pathology report
  • 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

  • Patients with invasive fungal infections
  • Patients with active and/or uncontrolled infections or who are still recovering from an infection
  • Actively febrile patients with uncertain etiology of febrile episode
  • All antibiotics should be completed at least 1 week (7 days) prior to collection
  • No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics
  • Note: Use of antibiotics for pre-operative prophylaxis is not an exclusion
  • Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e., quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA]) or known history of HCV, HBV, or HIV; testing for HBV, HCV, HIV or other infections for eligibility will be performed only if clinically indicated
  • Patients with hepatitis A as indicated by anti-hepatitis A virus (HAV) IgM reactivity
  • Patients that are anti-HAV IgG reactive only are eligible
  • Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR) based on imaging


Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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