Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02474160
Recruitment Status : Recruiting
First Posted : June 17, 2015
Last Update Posted : May 6, 2021
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
Lymphoma Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm Plasma Cell Myeloma Recurrent Lymphoma Recurrent Malignant Solid Neoplasm Recurrent Plasma Cell Myeloma Other: Cytology Specimen Collection Procedure

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Prospective
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, 2022

Resource links provided by the National Library of Medicine


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).


Biospecimen Retention:   Samples With DNA
Tissue and blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Study Population
Patients undergoing evaluation and/or treatment for cancer
Criteria

Inclusion 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

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
    • 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

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


Locations
Show Show 140 study locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: James H Doroshow National Cancer Institute LAO
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02474160    
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: May 6, 2021
Last Verified: May 2021
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders