NCT02474160招募中不适用
Patient-Derived Models Tissue Procurement Protocol for the National Cancer Institute (NCI)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 140
- 主要终点
- Procurement of tissue and blood specimens for research purposes
研究概览
简要总结
This study 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.
详细描述
PRIMARY OBJECTIVE:
I. To procure biologic tissues and materials to generate preclinical models of cancer.
OUTLINE: This is an observational study.
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 2 months of age 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
- •Complete blood count (CBC) w/differential indicative of a probable hematologic malignancy
- •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 histology must be confirmed to the coordinating site detailing the cancer diagnosis for patients enrolled based on the above criteria
- •Patients with a newly diagnosed primary and/or metastatic solid tumor or hematologic malignancy for which they have not yet received treatment
- •Patients with a solid tumor or hematologic 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, OR
- •CBC w/differential and/or flow cytometry for hematologic malignancies
- •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 residual malignancy and/or < 90% tumor necrosis, fibrosis, or hemorrhage must be confirmed to the National Cancer Institute (NCI) coordinating site, as indicated in the final post-operative/post-procedure pathology and/or flow cytometry report
- •Patients with ongoing partial response (PR) or stable disease (SD) are eligible
- •Confirmation of viable malignancy and/or < 90% tumor necrosis, fibrosis, or hemorrhage must be confirmed to the NCI coordinating site, as indicated in the final post-operative/post-procedure pathology and/or flow cytometry 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
- •For pediatric patients, ability and willingness to assent to participation, using an explanation that is understandable/age appropriate, as well as receiving parental permission. Signature requirements for pediatric patients can be adjusted based on local guidelines
排除标准
- •Patients with cancer-like syndromes and/or blood disorders such as systemic mastocytosis, Langerhans cell histiocytosis, chronic eosinophilic leukemia/hypereosinophilic syndrome, lymphomatoid granulomatosis, or monoclonal gammopathy of undetermined significance (MGUS)
- •Patients with invasive fungal infections
- •Patients with active and/or uncontrolled bacterial, fungal, or viral infections or who are still recovering from an infection
- •Actively febrile patients with uncertain etiology of febrile episode
- •All antibiotics prescribed for the treatment of a bacterial infection should be completed at least 1 week (7 days) prior to collection
- •Patients with a hematologic malignancy who are treated with an antibiotic, anti-fungal, and/or anti-viral medication for an active infection who then remain on the treatment for prophylaxis following resolution of the infection as assessed by the treating physician are not excluded
- •No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics
- •Patients receiving antibiotics, antifungals, and/or antivirals for prophylaxis are permissible
- •Antibiotics being administered topically at a location distant from the planned tissue collection site or eye drops for a localized infection are permissible
- •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)
研究组 & 干预措施
Observational (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.
干预措施: Cytology Specimen Collection Procedure (Other)
结局指标
主要结局
Procurement of tissue and blood specimens for research purposes
时间窗: 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).
次要结局
未报告次要终点
研究者
研究点 (140)
Loading locations...
相似试验
已完成
不适用
Tissue Procurement Protocol for Patients Undergoing Neoadjuvant Systemic Therapy for Breast CancerBreast CancerNCT00161265University of Michigan Rogel Cancer Center68
招募中
不适用
Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy ParticipantsUnspecified Adult Solid Tumor, Protocol SpecificNCT00992303University of Texas Southwestern Medical Center10,000
招募中
不适用
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic CancerChronic Myeloproliferative DisordersLymphoproliferative DisorderMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsNonmalignant NeoplasmLymphomaLeukemiaNCT01137643UNC Lineberger Comprehensive Cancer Center15,000
已完成
不适用
Genetic Analysis of Blood and Tissue Samples From Patients With Advanced Cancer, Moonshot StudyAdvanced Malignant NeoplasmAdvanced Renal Cell CarcinomaAnatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Stage IVB Ovarian Cancer AJCC v8Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8Prognostic Stage IV Breast Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage III Lung Cancer AJCC v8Stage III Ovarian Cancer AJCC v8Stage III Prostate Cancer AJCC v8Stage IIIA Colorectal Cancer AJCC v8Stage IIIA Lung Cancer AJCC v8Stage IIIA Ovarian Cancer AJCC v8Stage IIIA Prostate Cancer AJCC v8Stage IIIA1 Ovarian Cancer AJCC v8Stage IIIA2 Ovarian Cancer AJCC v8Stage IIIB Colorectal Cancer AJCC v8Stage IIIB Lung Cancer AJCC v8Stage IIIB Ovarian Cancer AJCC v8Stage IIIB Prostate Cancer AJCC v8Stage IIIC Colorectal Cancer AJCC v8Stage IIIC Lung Cancer AJCC v8Stage IIIC Ovarian Cancer AJCC v8Stage IIIC Prostate Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Stage IV Lung Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Prostate Cancer AJCC v8Stage IVA Colorectal Cancer AJCC v8Stage IVA Lung Cancer AJCC v8Stage IVA Ovarian Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8Stage IVB Colorectal Cancer AJCC v8Stage IVB Lung Cancer AJCC v8Stage IVB Prostate Cancer AJCC v8Stage IVC Colorectal Cancer AJCC v8Advanced MelanomaNCT03707574National Cancer Institute (NCI)64
已完成
不适用
SWOG-8819 Collecting, Analyzing, and Storing Tissue Samples From Patients With Non-Hodgkin's LymphomaLymphomaNCT00900484SWOG Cancer Research Network458