Patient-Derived Models Tissue Procurement Protocol for the National Cancer Institute (NCI)

STATUS

Recruiting
days left to enroll

88
participants needed

5000
sponsor

National Cancer Institute (NCI)

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Updated on 23 October 2022

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ct scan

cancer

lymphoma

multiple myeloma

tumor markers

metastasis

cancer diagnosis

primary cancer

solid tumor

metastatic solid tumor

immunostimulants

cytology specimen collection procedure

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.

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.

Details

Condition	Lymphoma, Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Plasma Cell Myeloma, Recurrent Lymphoma, Recurrent Malignant Solid Neoplasm, Recurrent Plasma Cell Myeloma
Treatment	cytology specimen collection procedure
Clinical Study Identifier	NCT02474160
Sponsor	National Cancer Institute (NCI)
Last Modified on	23 October 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
	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
	accessible to approach for study participation at that time, resected material
	Patients with a solid tumor, lymphoma or multiple myeloma malignancy that is recurrent, newly metastasized, or progressing while on treatment indicated by
	following cancer diagnosis confirmation is preferred
	Radiographic evidence of tumor growth, re-growth, and/or new metastases, OR
	Documentation by the treating physician of clinical disease progression
	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 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
	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 National Cancer Institute (NCI) coordinating site, as indicated in the final post-operative/post-procedure pathology report
	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
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 hepatitis A as indicated by anti-hepatitis A virus (HAV) IgM reactivity
	Patients that are anti-HAV IgG reactive only are eligible
	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
	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

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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Patient-Derived Models Tissue Procurement Protocol for the National Cancer Institute (NCI)