Neoplasms

Digestive System Diseases

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Stomach Neoplasms

Colorectal Neoplasms

Pancreatic Neoplasms

Cholangiocarcinoma

Bile Duct Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Stomach Diseases

Stomach Cancer

Pancreatic Cancer

Bile Duct Cancer

Subjects with or without solid tumors in whom diagnostic, preventative, or therapeutic intervention is being performed

Cathleen E Hannah, C.R.N.P.

Jeremy L Davis, M.D.

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Background:

- Recent advances in cancer research have led to new therapies to treat the disease. It is important to continue these advances and discover new ones. To do that, researchers need tissue samples from solid tumors. This study will collect such samples from people already scheduled to have a procedure at the National Institutes of Health Clinical Center (NIHCC).

Objectives:

- To collect tissue samples for use in studying new ways to treat tumors.

Eligibility:

* Adults 18 years and older, with a precancerous or cancerous solid tumor who are scheduled to have surgery or a biopsy at the NIHCC.
* Children under the age of 18 but who are older than 2 years of age are eligible to be enrolled on the research sample collection portion of this study if they will have a biopsy or surgery as part of their medical care.

Design:

* Before their procedure, participants will have a small blood sample taken.
* Some participants will undergo leukapheresis. In this procedure, blood is removed through a tube in one arm and circulated through a machine that removes white blood cells. The blood, minus the white blood cells, is returned through a tube in the other arm. The procedure takes 3-4 hours.
* For all participants, during the surgery or biopsy, pieces of the tumor and pieces of normal tissue near it will be removed for this study. The rest of the tumor or precancerous growth will be sent to a lab for analysis.
* Participants will return to the clinic about 6 weeks after the operation for a routine checkup. Some may have to return for additional follow-up.

Background:

Recent advances and insights into the molecular pathogenesis of cancer have led to the development of novel molecular and biologic targeted therapies for the treatment of advanced cancer patients. A critical challenge in extending these studies involves the identification and validation of new therapeutic targets for future cancer therapies.

As Surgical Oncologists at the NCI, we have an interest in identifying novel molecular and biologic targets to facilitate the development of future cancer therapies. In addition, we have the primary responsibility for providing surgical consultative services to the NIH. As such, we are uniquely positioned to acquire and perform important studies on solid tumor tissue to help identify therapeutic targets that may have significant clinical ramifications.

Objectives:

To collect biologic samples from patients undergoing diagnostic, preventative, or therapeutic interventions for premalignant, primary or metastatic solid tumors for the purpose of identifying novel molecular and biologic therapeutic targets.

Eligibility:

Patients age \>= 2 years and older with radiographic or clinical suspicion of, genetic predisposition for, biochemical evidence of, or histologically/cytologically proven solid neoplasms who require diagnostic, preventative, or therapeutic intervention as a part of the diagnosis and/or treatment and/or follow up for their neoplasm. Note: Patients \>= 2 years of age and under 18 years of age may only participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure, and the sampling of tissue, blood or urine does not add risk to the clinically indicated procedures.

Patients without solid tumors in whom a diagnostic, preventative, or therapeutic intervention is being performed, but for whom surgical quality and safety outcomes data are generated.

Patients should have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to planned intervention.

Design:

A tissue acquisition trial in which tissues will be obtained at the time of intervention.

No investigational therapy will be given.

It is anticipated that 1415 patients will be enrolled over a period of 10 years.

Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer

Tumor, Normal Tissue and Specimens From Patients Undergoing Evaluation or Surgical Resection of Solid Tumors

.All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

Identification of novel molecular and biologic therapeutic targets

Detailed history, demographic, treatment data, and perioperative outcomes data related to surgical quality and safety in order to categorize and track the specific procedures.

National Cancer Institute (NCI)

Blood and Lymph Conditions

Immune System Diseases

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Sarcoma

Osteosarcoma

Neuroblastoma

Sarcoma, Ewing

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Lymphoma

Neoplasms, Connective and Soft Tissue

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Nerve Sheath Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Soft Tissue Sarcoma

Acute Graft Versus Host Disease

Ewing Sarcoma

Neurofibromatosis

Neurofibromatosis Type 1

Lymphosarcoma

Neuroepithelioma

Children and young adults who are being evaluated for protocols within the Pediatric Oncology Branch.

Brigitte C Widemann, M.D.

Patients who are being considered for participation in a NCI Pediatric Oncology Branch research study will be screened for eligibility under this protocol. For every NCI research study, patients must meet defined medical criteria in order to ensure the integrity of the research study and to maximize patient safety.

Tests and procedures required for determining eligibility depend on the specific study for which the patient is being considered. Some of the more common tests and procedures are:

* History and physical examination
* Blood and urine samples for routine laboratory tests and possibly research studies
* Quality of life assessment questionnaire
* Magnetic resonance imaging (MRI) scan uses a magnetic field and radio waves to produce pictures of body structures, including tumors
* Computerized tomography (CT) scan uses radiation to produce multiple detailed pictures of body structures
* X-rays uses radiation to provide a single picture of a body part
* Nuclear medicine scans uses a chemical tagged with a radioactive substance to detect tumors, measure kidney or heart function, or monitor the flow of cerebrospinal fluid (fluid that bathes the brain and spinal cord)
* Electrocardiogram (EKG) uses electrodes placed on the skin to evaluates heart rate and rhythm by measuring electrical impulses from the heart
* Echocardiogram uses high-frequency sound waves to evaluate heart structure and function
* Lumbar puncture tests for cancer cells and other substances in cerebrospinal fluid. Involves placing a needle into the lower back between the bones of the spine and withdrawing a fluid sample from the fluid-containing space below the spinal cord
* Ommaya reservoir surgically implanted catheter inserted into the fluid-filled ventricles of the brain, used to withdraw spinal fluid samples and to give medication
* Eye examination vision test and eye examination
* Biopsies removal of a small piece of tissue, by needle or by surgery, for examination under the microscope. An area of skin over the biopsy site is numbed with an anesthetic. For a needle biopsy, a needle is inserted into the tumor, tissue or bone marrow to pull out a small sample. A surgical biopsy may be done in the operating room, clinic, or hospital room, depending on the biopsy location. The tissue or tumor is removed by cutting a small piece of it with a sharp knife or scalpel and the area will be closed with sutures or staples.

BACKGROUND:

* Patients, who are screened for POB research protocols, undergo a series of tests and procedures to determine protocol eligibility prior to entry onto the primary research protocol
* In some cases, specific research samples required for the primary research protocol may becollected during the screening process to prevent subjecting the patient to a painful procedure on multiple occasions.
* Performing invasive procedures for the sole purpose of obtaining tissue specimens or body fluids for research purposes is often not ethically justifiable in children, yet these specimens are needed to advance our knowledge of childhood cancers. Therefore, it is critical to obtain tissue and fluid samples for future research when procedures are performed for clinical indications.

OBJECTIVES:

* Evaluate patient eligibility for participation in POB research protocols.
* Collect clinical data, such as a medical history and clinical laboratory results that can serve as baseline values for subsequent research protocols.
* Procure residual tissues or fluids that are remaining from tests or procedures that are performed for clinical indications (e.g., diagnosis or treatment of the cancer) during the screening process or during treatment and follow-up on a primary POB research protocol. These specimens will be transferred to subsequent research protocols for IRB-approved research studies or stored for future research studies.

ELIGIBILITY:

* Children and young adults who are being evaluated for and treated on protocols within the Pediatric Oncology Branch.
* Patients or their parents/guardians can refuse to participate in the tissue procurement portion of this protocol and still participate in the screening for eligibility on POB research trials.

DESIGN:

* Patients who are being evaluated for POB primary research protocols will be entered onto this screening and tissue procurement protocol for eligibility screening and collection of tissue specimens.
* Procedures to be done may include, but are not limited to, laboratory tests on blood, CSF, urine, or other specimens; pulmonary function tests; TB skin tests (with a control); subspecialty consultations; molecular diagnostics on tumor tissues such as PCR for Ewing s or rhabdomyosarcoma, HLA, IHC, or FISH; radiographic and nuclear medicine studies, which may require the administration of contrast or a radioisotopic tracer; and needle or open biopsies for diagnostic purposes.
* Tissues and body fluids that are obtained during or after the screening process or at any time during treatment and follow-up on a primary POB research protocol will be discarded or stored for future research purposes with the consent of the patient or his/her parent or guardian, if the patient is not eligible for or elects not to enroll on the primary research protocol. These specimens will be stored with patient identifiers, IRB approval will be requested prior to performing any research with these tissues or fluids or the samples will have identifiers removed (unlinked) and an exemption will be requested from OHSRP.

Eligibility Screening for a NCI Pediatric Oncology Branch Research Study

Eligibility Screening and Tissue Procurement for the National Cancer Institute (NCI), Pediatric Oncology Branch (POB) Clinical Research Protocols

Hematologic Neoplasms

patients undergoing allogeneic stem cell transplantation

Kristen Gunn E Wood, R.N.

Richard W Childs, M.D.

This study will collect biological samples for use in research experiments aimed at better understanding the clinical features of certain diseases. The specimens may be used to evaluate the effectiveness of known therapies, refine treatment approaches, identify potential new therapies, and explore opportunities for disease prevention.

The following individuals 2 years of age or older may be eligible for this study:

* Patients with a cancerous solid tumor or a cancerous or non-cancerous blood disorder who are being screened for or who are enrolled in a treatment study at the NIH Clinical Center
* HLA-compatible donor family members (18 years of age or older) of the above patients who are being evaluated for or are enrolled in an NIH study as a stem cell transplant donor
* Patients with a cancerous solid tumor or a cancerous or non-cancerous blood disorder or a bone marrow failure condition who cannot participate in an NIH treatment protocol or travel to the NIH Clinical Center and who are referred for participation through their home health care provider.

Research samples will be collected from participants when blood is drawn or bone marrow, urine, or stool is collected, or tumor or other tissue is biopsied as part of their general medical care. Investigators may periodically request an additional sample of blood, stool, or urine. Participants who are 18 years of age or older may donate a large number of white blood cells through a procedure called leukapheresis. This procedure is not part of general medical care and would be done for research purposes only. For apheresis, a catheter (plastic tube) is placed in a vein in the subject's arm. Blood flows from the vein into a cell separator machine, where the white cells are separated from the red cells, platelets, and plasma by a spinning process. The white cells are removed and collected, and the rest of the blood is returned to the subject through a second tube placed in the other arm.

The purpose of this protocol is to collect blood, bone marrow, urine, stool, oral samples, nasopharyngeal samples and/or both malignant and non-malignant tissue from patients who are either being evaluated for enrollment, are consented to NIH Clinical Center treatment protocols, or are receiving therapy for their disease through home health care providers. Since a substantial proportion of the clinical and translational research in the NHLBI involves patients undergoing allogeneic stem cell transplantation, this protocol will also be open to people identified as suitable HLA compatible donors for patients undergoing evaluation for or already enrolled in an allogeneic stem cell transplant protocol or receiving a stem cell transplant through their home health care providers. These HLA compatible donors will serve as a source of peripheral blood mononuclear cells (peripheral blood draws or leukapheresis) for use in evaluating allogeneic graft versus host and graft-versus-tumor effects.

The primary objective is to provide a mechanism for collection, tracking, storing, dispensing, analyzing, and disposing of these laboratory research samples from patients and HLA matched donors.

There is no primary endpoint.

Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members

Collection of Blood, Bone Marrow, Urine, and/or Tissue Samples From Patients With Solid Tumors, Hematological Malignancies or Non-Malignant Hematologic Disorders or HLA Compatible Family Members

National Heart, Lung, and Blood Institute (NHLBI)

MTX polyglutamylation, MTX transport, XTT cytotoxicity assays, Quantitative RT-PCR, Southern blotting, Mutation detection, and Western blotting

Tissue Procurement

John Healey, MD

The purpose of this study is to investigate tumors in the laboratory to determine how and why they respond, or fail to respond to different drug therapies. This study will also investigate why high pressure develops within tumors and how this affects how well drugs work. We will also take blood samples before and/or after your procedure to measure biochemical factors that may help us predict the behavior of osteogenic sarcoma and other solid tumors.

When tumor tissue known or presumed to be a primary or secondary bone cancer or solid tumor with known elevated intra-tumoral pressure such as retinoblastoma is being removed or has been removed for diagnostic or therapeutic reasons a small sample of it will be obtained for this study. The tumor samples will be used to study in vitro, determinants of chemotherapy resistance and oncogenesis. These determinants will be correlated with histologic response to preoperative chemotherapy and clinical outcome (event free survival). In addition, blood samples (20ml) may be obtained before or after the procedure.

Chemotherapy Resistance in Osteogenic Sarcoma and Other Solid Tumors

Hospital for Special Surgery, New York

Weill Medical College of Cornell University

Columbia University

Rockefeller University

Memorial Sloan Kettering Cancer Center

Breast Neoplasms

Breast Diseases

Skin Diseases

tissue procurement

Anne F. Schott, M.D.

This study is being performed so that tumor and blood samples from patients who will receive breast cancer treatment prior to surgery can be collected and stored for future research.

This protocol will provide a systematic approach to obtaining, cataloging, and distributing research tissue and blood from patients who will receive neoadjuvant systemic therapy for localized breast cancer.

Tissue Procurement Protocol for Patients Undergoing Neoadjuvant Systemic Therapy for Breast Cancer

UMCC 2004.064: Tissue Procurement Protocol for Patients Undergoing Neoadjuvant Systemic Therapy for Breast Cancer

University of Michigan Rogel Cancer Center

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasm, Residual

Neoplastic Processes

Chronic Graft Versus Host Disease

Myeloid Leukemia

Chronic Myeloid Leukemia

Although allogeneic stem cell transplantation is curative in CML, evidence of the BCR-ABL oncogene at low levels is still found in long-term follow-up of survivors. Such low levels of BCR-ABL post-transplant which do not fulfill criteria for molecular relapse are monitored regularly and considered to be suppressed by the GVL effect. Treatment with donor lymphocyte infusions is only instituted when quantifiable BCR-ABL transcript levels rise steadily, indicative of a true molecular relapse .

Similarly, BCR-ABL is still detectable in the majority of CML patients treated with imatinib who achieve complete cytogenetic response, although the amount of BCR-ABL transcripts seem to decline with longer follow-up. With 5 years follow-up of CML patients at CP who received imatinib, the estimated cumulative best rates of complete hematologic response and complete cytogenetic response were 98 percent and 87 percent, respectively10. For the minority of CP-CML patients who do not respond satisfactorily to imatinib, second-generation tyrosine kinase inhibitors are now the recommended next line of treatment.

A major question facing clinicians is whether imatinib and the other more pharmacologically potent second-generation tyrosine kinase inhibitors;can suppress the CML clone at the leukemic stem cell level as effectively as allogeneic stem cell transplantation. This protocol is designed to scientifically compare the treatment responses of patients who are treated with allogeneic stem cell transplantation with patients who receive imatinib or second generation tyrosine kinase inhibitors.

The primary endpoint of this trial will be the proportion of patients who have detected minimal residual disease (DMRD) in primitive CD34 plus progenitor subpopulations no earlier than 60 days from the onset of their respective treatments.

Although allogeneic stem cell transplantation is curative in CML, evidence of the BCR-ABL oncogene at low levels is still found in long-term follow-up of survivors. Such low levels of BCR-ABL post-transplant, which do not fulfill criteria for molecular relapse are monitored regularly and considered to be suppressed by the GVL effect. Treatment with donor lymphocyte infusions is only instituted when quantifiable BCR-ABL transcript levels rise steadily, indicative of a true molecular relapse."

Similarly, BCR-ABL is still detectable in the majority of CML patients treated with imatinib who achieve complete cytogenetic response, although the amount of BCR-ABL transcripts seem to decline with longer follow-up. With 5 years follow-up of CML patients at CP who received imatinib, the estimated cumulative best rates of complete hematologic response and complete cytogenetic response were 98 percent and 87 percent, respectively 10. For the minority of CP-CML patients who do not respond satisfactorily to imatinib, second-generation tyrosine kinase inhibitors are now the recommended next line of treatment.

A major question facing clinicians is whether imatinib and the other more pharmacologically potent second-generation tyrosine kinase inhibitors can suppress the CML clone at the leukemic stem cell level as effectively as allogeneic stem cell transplantation. This protocol is designed to scientifically compare the treatment responses of patients who are treated with allogeneic stem cell transplantation with patients who receive imatinib or second generation tyrosine kinase inhibitors.

The primary endpoint of this trial will be the proportion of patients who have detected minimal residual disease (DMRD) in primitive CD34 plus progenitor subpopulations no earlier than 60 days from the onset of their respective treatments.

Collection of Blood and Bone Marrow Samples From Select Patients With CML to Measure Minimal Residual Disease

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer	NCT01915225	Colorectal Neop... Gastric Neoplas... Cholangiocarcin... Bile Duct Cance... Pancreas Cancer		2 Years -	National Institutes of Health Clinical Center (CC)
Eligibility Screening for a NCI Pediatric Oncology Branch Research Study	NCT00026780	Ewing Sarcoma Osteosarcoma Neuroblastoma Acute Lymphobla... Neurofibromatos...		- 35 Years	National Institutes of Health Clinical Center (CC)
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members	NCT00071045	Neoplasms Hematologic Neo... Healthy Volunte...		2 Years - 100 Years	National Institutes of Health Clinical Center (CC)
Chemotherapy Resistance in Osteogenic Sarcoma and Other Solid Tumors	NCT00580385	Osteosarcoma	Tissue Procurem...	-	Memorial Sloan Kettering Cancer Center
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer	NCT01915225	Colorectal Neop... Gastric Neoplas... Cholangiocarcin... Bile Duct Cance... Pancreas Cancer		2 Years -	National Institutes of Health Clinical Center (CC)
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer	NCT01915225	Colorectal Neop... Gastric Neoplas... Cholangiocarcin... Bile Duct Cance... Pancreas Cancer		2 Years -	National Institutes of Health Clinical Center (CC)
Eligibility Screening for a NCI Pediatric Oncology Branch Research Study	NCT00026780	Ewing Sarcoma Osteosarcoma Neuroblastoma Acute Lymphobla... Neurofibromatos...		- 35 Years	National Institutes of Health Clinical Center (CC)
Chemotherapy Resistance in Osteogenic Sarcoma and Other Solid Tumors	NCT00580385	Osteosarcoma	Tissue Procurem...	-	Memorial Sloan Kettering Cancer Center
Tissue Procurement Protocol for Patients Undergoing Neoadjuvant Systemic Therapy for Breast Cancer	NCT00161265	Breast Cancer	tissue procurem...	18 Years -	University of Michigan Rogel Cancer Center
Collection of Blood and Bone Marrow Samples From Select Patients With CML to Measure Minimal Residual Disease	NCT00819143	Leukemia		18 Years -	National Institutes of Health Clinical Center (CC)
Collection of Blood and Bone Marrow Samples From Select Patients With CML to Measure Minimal Residual Disease	NCT00819143	Leukemia		18 Years -	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for tissue procurement