NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




NCI Community Oncology Research Program - Protocol Summary

CTSU 9846 - "PATIENT-DERIVED MODELS TISSUE PROCUREMENT PROTOCOL FOR THE NATIONAL CANCER INSTITUTE (NCI)" This study is limited to site MO179 CCCC-Bolivar

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.


This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
 

Please contact NCORP-KC for complete protocol information.



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Any Site Clinical Trial

CANCER TYPE: Any Site
RESEARCH BASE: CTSU
NCT NUMBER: NCT02474160
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM

BRIEF DESCRIPTION

Collection of blood and tumor tissue from cancer patients for research purposes.



NOTES


This is NOT a treatment trial.  Blood and tissue collection only.

Samples collected on this protocol will be used to generate patient-derived xenograft (PDX) models and/or novel cell lines and materials, which will require the collection of limited medical information (specifically age, sex, diagnosis, prior therapies, response to therapy, current therapy, response to most recent regimen, as well as tobacco exposure history, race/ethnicity, and occupation) for correlation with data obtained from the genetic analysis (including genomic/exomic analysis) of their samples.



ELIGIBILITY

  • Patients with a histologically or cytologically confirmed diagnosis of cancer who are being evaluated and/or treated for cancer 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 or equal to 18 years.
  • No patients with invasive fungal infections
  • No 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.
  • No 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.
  • No tumor tissue or blood collections from patients with benign tumors including desmoid tumors, carcinoma in situ, or ongoing complete disease response (CR).
    • Tumor tissue collected from patients on treatment and demonstrating partial (PR) or stable disease (SD) response will require pathology confirmation sent to the coordinating site of viable malignancy and <90% tumor necrosis; or
    • Documentation of clinical progression by the assessing physician.
  • Blood will not be collected from patients whose disease demonstrates ongoing partial response or who are currently on treatment with ongoing (i.e., prolonged) stable disease given the poor rate of model generation from such samples.
  • Both men and women and members of all races and ethnic groups are eligible for this study





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