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Collection and Storage of Tissue and Blood Samples From Patients With Cancer

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ClinicalTrials.gov Identifier: NCT02474160
Recruitment Status : Recruiting
First Posted : June 17, 2015
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Malignant Neoplasm Other: Cytology Specimen Collection Procedure

Detailed Description:

PRIMARY OBJECTIVES:

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.


Study Type : Observational
Estimated Enrollment : 5000 participants
Official Title: Patient-Derived Models Tissue Procurement Protocol for the National Cancer Institute (NCI)
Actual Study Start Date : May 15, 2015
Estimated Primary Completion Date : May 4, 2020

Group/Cohort Intervention/treatment
Ancillary-correlative (tissue and blood procurement)
Tumor tissue and blood samples are procured during procedures that are required for the patients? clinical management and stored via xenograft (transplant to another species) models or in vitro cell culture for future analysis.
Other: Cytology Specimen Collection Procedure
Procurement of tissue and blood samples
Other Name: Cytologic Sampling




Primary Outcome Measures :
  1. Procurement of tissue and blood specimens for research purposes [ Time Frame: Up to 5 years ]
    Tissues and venous blood will be stored, implanted immediately to generate patient-derived xenografts (which require fresh, viable cells), or placed immediately into in vitro cell culture to generate patient-derived cell lines (which require fresh, viable cells).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Criteria

Inclusion Criteria:

  • 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

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 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 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)

    • 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 collection only:

    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474160


  Show 140 Study Locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: James Doroshow National Cancer Institute LAO

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02474160     History of Changes
Other Study ID Numbers: NCI-2015-00863
NCI-2015-00863 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P9846
P9846_R02PAPPHOLD01
9846 ( Other Identifier: National Cancer Institute LAO )
9846 ( Other Identifier: CTEP )
UM1CA186689 ( U.S. NIH Grant/Contract )
UM1CA186691 ( U.S. NIH Grant/Contract )
UM1CA186704 ( U.S. NIH Grant/Contract )
UM1CA186709 ( U.S. NIH Grant/Contract )
UM1CA186717 ( U.S. NIH Grant/Contract )
ZIABC011078 ( U.S. NIH Grant/Contract )
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Neoplasms