Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Eye Diseases

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Carcinoma, Renal Cell

Retinoblastoma

Sarcoma

Endocrine Gland Neoplasms

Neuroblastoma

Kidney Neoplasms

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Retinal Neoplasms

Eye Neoplasms

Eye Diseases, Hereditary

Retinal Diseases

Endocrine System Diseases

Renal Cell Carcinoma

Soft Tissue Sarcoma

Neuroepithelioma

Adult or Pediatric subjects, with any malignancy, pre-malignancy, suspected malignancy, family history of malignancy, or without malignancy undergoing surgery or well visit.

Human samples, specimens and data collected on IRB approved protocols that are now closed

Parent/caregiver of a participating pediatric or adult subject who is being treated for, or who has previously been treated for any form of pediatric cancer.

Donna B Bernstein, R.N.

Rosandra N Kaplan, M.D.

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

Background:

- Laboratory investigators who are studying common childhood cancers are interested in developing a tissue repository to collect and store blood, serum, tissue, urine, or tumors of children who have cancer or adults who have common childhood cancers. To develop this repository, additional samples will be collected from children and adults who have been diagnosed with common childhood cancers such as leukemia and tumors of the central nervous system.

Objectives:

- To collect and store blood, serum, tissue, urine, or tumor samples of children who have cancer or adults who have common childhood cancers.

Eligibility:

* Individuals who have been diagnosed with a common childhood cancer (e.g., leukemia) regardless of patient age.
* Children, adolescents, and adults who have been diagnosed with a type of cancer more commonly found in adults.

Design:

* Extra blood, serum (the liquid part of blood), tissue, urine, or tumor samples will be collected from participants at a time when sampling is required for medical care or as part of a research study.
* No additional procedures will be performed for the sole purpose of obtaining additional tumor tissue, aside from what is required for clinical care.

Background:

-Laboratory-based investigations have contributed to an improved understanding of the biology of cancer and to the development of new therapies for pediatric malignancies.

Objectives:

-Systematic Molecular, Genomic, Proteomic, Metabolomic ( Omic ) and other profiling for enrolled subjects.

Eligibility:

Pediatric or Adult subjects of any age with one of the following:

* Diagnosis of any tumor or malignancy, pre-malignant disorder or suspected cancer susceptibility familial syndromes, regardless of age
* Individuals without malignancy undergoing surgery, other treatment or normal well visit.
* Biological relatives of a subject with a pediatric tumor or malignancy or with suspected familial cancer syndrome.
* Patients enrolled in an approved companion protocol
* Blood and/or tissue specimens that have been previously collected and are available for research analysis
* Biospecimens can be collected with minimal additional risk to the subject during sampling or procedures required for routine patient care.

Design:

* This study will allow for the collection of specimens for a Tissue Repository, and for designated sample investigations including systematic molecular, genomic and proteomic (Omic) profiling, and growth factor and cellular profile investigations.
* Testing activities may include:

  * DNA, RNA and protein will be extracted from a section of tumor samples, the remainder will be stored.
  * Germ line DNA and RNA will be extracted from lymphocytes or other normal uninvolved tissue
  * Germ line DNA will be extracted from lymphocytes or other normal uninvolved tissue of the biological relatives of the subject.
  * Xenografts, explant and cell lines established from tumor, pre-malignant and normal samples
  * Tumor samples and samples for circulating tumor cells sent for the establishment of Xenografts and single cell suspension of tumor for drug testing
  * Omics (Genomics and Proteomic) studies will be performed
  * Growth factor and cellular profile investigations of bone marrow-derived cell populations to include quantification of hematopietic progenitor cells (HPCs), endothelial progenitor cells (EPCs), and mesenchymal progenitor cells (MPCs), levels of matrix metalloprotease 2 and 9 (MMP2) and (MMP9), gene expression, growth factor and microvesicle analysis and bone marrow analysis of progenitor cells in blood and tissue.
  * Research tests described in active IRB approved protocols
  * Immune profiling and stromal profiling of blood, tumor, and normal tissues
  * Immune function studies from blood and normal tumor tissues
* Utilizing an oversight committee to oversee the receipt and the distribution of unlinked tissues to other investigators.
* Qualitative methodologies will be used to ascertain knowledge, attitudes, beliefs, and behaviors in 25-35 parents/caregivers at NIH concerning the anticipated use of NGS for diagnosing and directing therapy for pediatric cancer and how incidental findings might be returned.
* Expected accrual 100-150 patients per year.

Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies

.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.

Perform systematic molecular, genomic, proteomic, metabolomics and other high throughput ( Omics ) profiling on tumor and normal tissues

National Cancer Institute (NCI)

Digestive System Diseases

Rectal Neoplasms

Colonic Neoplasms

Appendiceal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Cecal Neoplasms

Cecal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

Oxaliplatin

Topoisomerase I Inhibitors

Enzyme Inhibitors

Oxaliplatin and irinotecan

Dominique Elias, MD

The purpose of this study is to evaluate the treatment of a cancerous disease of the peritoneum with complete cytoreductive surgery with intraperitoneal chemohyperthermia using oxaliplatin plus irinotecan.

This is a Phase II study with 100 patients. Origins of the tumors: these include colon, rectum, appendix, peritoneum, and endocrine tumors.

Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery and Intraperitoneal Chemohyperthermia

Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery With Intraperitoneal Chemohyperthermia Using Oxaliplatin Plus Irinotecan

Gustave Roussy, Cancer Campus, Grand Paris

Symptoms and General Pathology

Pancreatic Neoplasms

Disease Progression

Pancreatic Cancer

Pancreatic Neuroendocrine Tumor

Pharmaceutical Solutions

Lanreotide

120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.

lanreotide (Autogel formulation)

Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.

Placebo

Medical Director, Endocrinology

The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.

Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours

Phase III, Randomised, Double-blind, Stratified Comparative, Placebo Controlled, Parallel Group, Multi-centre Study to Assess the Effect of Deep Subcutaneous Injections of Lanreotide Autogel 120mg Administered Every 28 Days on Tumour Progression Free Survival in Patients With Non-functioning Entero-pancreatic Endocrine Tumour

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

Time from randomization to first documentation of disease progression, or death. Disease progression centrally assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.0

Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.

Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints

Transformed scores from European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire responses (QLQ)-C30. Questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.

Overall survival defined as the time from randomisation to death due to any cause. Subjects were followed for overall survival beyond study completion/withdrawal via annual telephone contact until the last subject completed the study.

Ipsen

Lanreotide (Autogel Formulation)

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Time relative to baseline visit (Week 1).

Time since diagnosis

Pancreas

Midgut

Hindgut

Unknown/Other

Neuroendocrine tumour (NET) origin

≤1 × ULN

1-2 × ULN

>2 × ULN

Unknown

Chromogranin A is an NET marker. ULN: upper limit of normal.

Chromogranin A

Analysis based on intent-to-treat (ITT) population comprised of 204 subjects.

Medical Director Endocrinology

lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.

Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.

Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects.

Progression-Free Survival (PFS)

Week 48

Week 96

Percentage of Patients Alive & Without Disease Progression

At Week 4 predose (n=81)

At Week 12 predose (n=87)

At Week 24 predose (n=74)

At Week 36 predose (n=67)

At Week 48 predose (n=62)

At Week 72 predose (n=52)

At Week 96 predose (n=48)

lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.

Analysis based on the intent-to-treat (ITT) population which comprised 101 randomised subjects who received lanreotide

Pharmacokinetic Profile of Lanreotide

Analysis based on the intent-to-treat (ITT) population which comprised 193 randomised subjects with valid assessment.

Change in the Global Health Status Quality of Life Assessment

Analysis based on the subgroup of subjects with an elevated plasma CgA values. Subjects with a gastrinoma were excluded from the analysis.

Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels

Percentage of Patients Still Alive Based on Available Overall Survival Data

Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.

Overall Study

Stomach Neoplasms

Colorectal Neoplasms

Carcinoid Tumor

Colonic Diseases

Rectal Diseases

Pancreatic Diseases

Stomach Diseases

Stomach Cancer

Adult patients with well defined grade 1 and grade 2 GEP-NETs. Serial serum samples from all patients will be analyzed using the BRAHMS CgA II KRYPTOR Assay.

The BRAHMS CgA II KRYPTOR kit is an automated immunofluorescent assay for the quantitative determination of the concentration of CgA in human serum.

The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in patients with GEP-NETs (grade 1 and grade 2).

Serial testing for patient BRAHMS CgA II KRYPTOR assay values should be used in conjunction with other clinical methods for monitoring GEP-NETs (grade 1 and grade 2).

BRAHMS CgA II KRYPTOR

Daniel M Halperin, MD

Gastroentero-pancreatic neuroendocrine tumors (GEP-NETs) are a heterogenous group of neoplasms that arise from enterochromaffin cells of the gastrointestinal (GI) tract and pancreas. They account for 50-70% of all incident NETs. Due to the lack of symptoms in the early stage of disease and the frequency of nonspecific GI symptoms, GEP-NETs are difficult to diagnose.

Identification of effective biomarkers (such as Chromogranin A) to improve GEP-NET diagnosis, as well as to assess treatment efficacy, relapse and prognosis, is important for improving outcomes for patients with GEP-NETs.

The purpose of this study is to validate the performance of Brahms (BRAHMS) Chromogranin A II Kryptor (KRYPTOR) assay to monitor the course of disease in patients with well-defined GEP-NETs.

A general characteristic for neuroendocrine tumors (NET) is expression of chromogranin A (CgA), which is released from neuroendocrine cells, occasionally together with cell specific hormones such as gastrin, insulin, somatostatin, and serotonin in functional tumors. Human CgA is an acidic 439 amino acid protein with a sequence containing several mono- and dibasic cleavage sites, and correspondingly, numerous fragments of CgA have been identified in tissue and plasma. CgA is critical to the formation of secretory granules that characterize NETs, and is therefore a useful marker for NETs.

Plasma concentrations of CgA and/or CgA fragments are elevated in most NETs. Moreover, since plasma CgA concentrations seem to be closely related to tumor burden in humans, plasma CgA concentration is an important prognostic factor. As such, high plasma concentrations of CgA as well as a dramatic increase in plasma CgA within a short time period, is associated with a poorer prognosis. Plasma CgA has also been suggested to be useful in the follow-up of patients with NETs.

Taken together, these observations support the notion that CgA is a promising biomarker candidate for monitoring treatment effectiveness and disease progression or regression.

Participation in this clinical study requires no additional visits to the oncologist, radiology or the laboratory. All information needed for the study will be obtained during typical visits as recommended by the oncologist. Clinical assessment of patients with GEP-NETs (according to NCCN guidelines) is based on physical exam, imaging (CT or MRI scans) and laboratory parameters. The course of disease is followed by RECIST 1.1 categorization including the evaluation of tumor burden by imaging.

Chromogranin A as Blood Marker in Cancer Patients

Chromogranin A as Surveillance Biomarker in Patients With cARcinoids (The CASPAR Study)

Progression vs. non-progression in patients with well-defined GEP-NETs assessed by RECIST 1.1 criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies	NCT01109394	Sarcoma Endocrine Tumor... Neuroblastoma Retinoblastoma Renal Cancer		4 Weeks -	National Institutes of Health Clinical Center (CC)
Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery and Intraperitoneal Chemohyperthermia	NCT00180960	Colon Tumors Rectum Tumors Appendix Tumors Peritoneum Tumo... Endocrine Tumor...	Oxaliplatin and...	18 Years - 65 Years	Gustave Roussy, Cancer Campus, Grand Paris
Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours	NCT00353496	Endocrine Tumor...	lanreotide (Aut... Placebo	18 Years -	Ipsen
Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours	NCT00353496	Endocrine Tumor...	lanreotide (Aut... Placebo	18 Years -	Ipsen
Chromogranin A as Blood Marker in Cancer Patients	NCT03817866	Gastric Neoplas... Pancreatic Neop... Small Intestina... Colorectal Neop...	BRAHMS CgA II K...	18 Years - 85 Years	Brahms AG

Spots Global Cancer Trial Database for endocrine tumors