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Clinical Trial VICCMD1494


Specimen Collection under Clinical Protocol 06-C-0213 for Generation of Patient-Derived Models

Principal Investigator(s)

Jennifer Pietenpol


  • Protocol No. VICCMD1494
  • Open Date: 10/31/2014
  • Staging: N/A
  • Age Group: Adults
  • Scope: National
  • Objective: Overview of Specimen Collection and Handling under Clinical Protocol 06-C-0213 for Generation of Patient-Derived Models
  • Disease Sites: Miscellaneous; Lung; Small Cell
  • Therapies: None Specified
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT00900198
  • Secondary Protocol No: Not Specified


None Provided.


Ages Eligible for Study:18 Years to 110 Years
Genders Eligible for Study:All
Accepts Healthy Volunteers:No


Inclusion Criteria:
• Patients who are being evaluated and or treated for cancer 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
Exclusion Criteria:
• 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
• Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e., quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA) or known history of HCV or HBV without documented resolution. Testing for hepatitis B or other infections for eligibility will be performed only if clinically indicated.
• Tumor tissue or blood collections from patients with benign tumors including desmoid tumors, carcinoma in situ, or ongoing complete disease response (CR).
• Blood only collections from patients with partial or stable disease response
• Blood will not be collected from patients whose disease demonstrates ongoing partial response or with ongoing (i.e., prolonged) stable disease given the poor rate of model generation from such samples.
• Blood will not be collected from patients between doses within a single treatment cycle