Collection and Storage of Tissue and Blood Samples from Patients with Cancer
Lymphoma
Multiple Myeloma
Plasma cell neoplasm
Solid Tumor
18 Years and older, Male and Female
9846 (primary)
9846
NCI-2015-00863
P9846
P9846_R02PAPPHOLD01
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.
Objectives
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.
Eligibility
- Patients 18 year of age or older who are being evaluated, treated or enrolled in a clinical trial for cancer at participating sites
- 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 NCI 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
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.