Neoplasms

Gland and Hormone Related Diseases

All Conditions

Endocrine Gland Neoplasms

Background:

* Tumors depend on blood vessels to provide the nourishment that allows them to grow.
* Thyroid, parathyroid, adrenal gland and pancreatic neuroendocrine tumors are among the tumors that contain the most blood vessels. Thus, endocrine tumors are important for the study of new blood vessel formation in tumors.

Objectives:

-To obtain tissues from endocrine tumors for examination to determine how they differ from normal tissue.

Eligibility:

-Patients who are scheduled for surgery to remove an endocrine tumor, those in or around the thyroid, parathyroid, adrenal gland, pancreas, or any neuroendocrine tissue.

Design:

* Tissues will be obtained from patients during surgery to remove thyroid, parathyroid, adrenal, pancreas, or neuroendocrine tumors.
* About 400 patients will be enrolled in the study over a period of 5 years.

Background:

* Endocrine neoplasms are among the fastest growing tumors in incidence in the United States. Between 1995 and 2005, the incidence of thyroid carcinoma has increased 98 percent.
* Tumors of the thyroid, parathyroid, adrenal gland and pancreatic neuroendocrine tumors are among some of the most highly vascularized tumors seen.
* Consequently, endocrine neoplasms provide an extremely important model for the study of tumor angiogenesis.
* The Tumor Angiogenesis Section of the Surgery Branch, NCI has a focus on studying neovascular formation in neoplastic tissues. In addition, this section has primary responsibility for providing endocrine surgery consultative services to the NIH. As such, our Section is uniquely positioned to acquire and perform important studies on endocrine tissue to help advance our knowledge of the mechanisms involved in tumor vessel development. The majority of the patients enrolled on this study will be patients on other protocols throughout the NIH, for which our Section is consulted in order to perform their surgery.

Objectives:

Primary Objective:

-To develop a class predictor model based on gene expression patterns to distinguish benign from neoplastic endocrine tissue for each of the endocrine histologies under study. This objective will drive the statistical endpoints of the study.

Secondary Objectives:

* To utilize the tissue obtained from these endocrine neoplasms for studies of gene expression changes, proteomic changes, and methylation changes.
* To perform histologic examination of these tissues including immunohistochemistry and in situ hybridization in order to study changes in tumor neovessel formation.
* To obtain, when accessible, adjacent normal endocrine tissue for comparison with the neoplastic tissue.
* To collect tissues from endocrine neoplasms arising in the thyroid, parathyroid, adrenal, pancreas, and extraadrenal neuroendocrine rests for future analysis and correlation with clinical outcome.

Eligibility:

* Patients with radiographic evidence of, biochemical evidence of, or histologically/cytologically proven, endocrine neoplasms, including lesions of the thyroid, parathyroid, adrenal, extra-adrenal endocrine rests, paragangliomas, neuroblastomas and pancreas.
* Patients must have an ECOG performance score of 0-2.
* Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery.

Design:

* A tissue acquisition trial in which tissues will be obtained at the time of surgical operation for the removal of neoplasms of the thyroid, parathyroid, adrenal, pancreas, paragangliomas and or extraadrenal rests of neuroendocrine tissue.
* Tissue will be processed at the time of collection, stored and then shipped to the PI's laboratory for further processing.
* No investigational therapy will be given.
* It is anticipated that 400 patients will be enrolled over a period of 5 years.

Evaluation of Blood Vessel Formation in Endocrine Tumors

Prospective Evaluation of Tumor Angiogenesis in Endocrine Neoplasms

National Cancer Institute (NCI)

Digestive System Diseases

Rare Diseases

Pancreatic Neoplasms

Neoplasms, Cystic, Mucinous, and Serous

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Procedure/Surgery Thermal Radiofrequency Ablation under endoscopic ultrasonography guidance of the pancreatic neuro endocrine tumor or mucinous cyst.

Pancreatic radiofrequency ablation under endoscopic ultrasonography guidance Procedure under general anesthesia Punction of the pancreatic lesion and aspiration of the liquid if present / then thermal ablation with a 18G needle (50 W during 10 secondes) - only one session

Radiofrequency Ablation under EUS

Marc Barthet, MD, PhD

Advances in conventional imaging (abdominal ultrasound, CT scan, MRI) are so great that chance to discover a incidental solid or cystic pancreatic lesion is becoming usual. Endocrine tumors have variable malignant potential depending on their size, some malignancy for lesions larger than 2 cm and indefinite for a smaller size. The branch-duct like IPMN (intraductal papillary mucinous pancreatic tumor) involving the pancreatic secondary ducts represent half of pancreatic cystic tumors and may degenerate into 5 to 10% of cases. Signs and risk of degeneration are the presence of mural nodules greater than 5 mm and size \> 3 cm, although the latter criterion is discussed. Mucinous cystadenomas could degenerate between 30 and 50% of cases even though the role of size is much discussed (\<4 cm). The follow-up imaging is performed using MRI and endoscopic ultrasonography (EUS). A fine needle aspiration for cytology and histology is possible and determination of biological markers is useful. But cytology is often unprofitable due to the poor cellular profile of the cystic pancreatic tumor. Once the diagnosis of suspected malignancy, the patient should be referred to the surgeon for pancreatic resection more or less extensive. But this attitude is facing a significant operative risk with up to 30% of morbidity and mortality between 1 and 3 % for cephalic resections. Some patients with high post operative risks are inoperable. For these reasons, some teams have proposed the destruction of the walls of the cyst under EUS, US or CT control by washing with absolute alcohol content of cystic tumor.

An interesting alternative endoscopic destruction would be the use of radio frequency ablation technique (RFA). RFA is a recognized technique for local tumor destruction by delivering thermal energy to obtain coagulation necrosis of the lesion. Taewong Medical ™ recently developed a radiofrequency needle EUSRA® coupled with a combo VIVA ™ generator for applying RFA sub EUS control. But no prospective study is available at this date regarding the treatment of the cystic or solid tumoral pancreatic lesion with this technique. The primary endpoint of the present study is to investigate the feasibility and safety of this guided radiofrequency probe EUS for the treatment of pancreatic endocrine tumors or inoperable pancreatic cystic tumors. The secondary objective will be the efficiency.

Efficacy and Safety of Radiofrequency Ablation in Pancreatic Neuroendocrine and Cystic Tumor

Efficacy and Safety of Radiofrequency Ablation Under Endoscopic Ultrasonography Guidance in Pancreatic Neuroendocrine and Cystic Tumor

Decrease of the size of the lesion using CT-scan and tumoral response using the Response Evaluation Criteria in Solid Tumors criterion

Société Française d'Endoscopie Digestive

MD, MSc

Thyroid Diseases

Vasoconstrictor Agents

Respiratory System Agents

Gastrointestinal Agents

Epinephrine

Pancrelipase

Racepinephrine

Epinephryl borate

Pancreatin

Parathyroid Hormone

* Patients who undergo thyroid surgical procedures. This registry was declared at the commission national informatique et libertés (CNIL) with the number R2015-22.
* Patients who undergo parathyroid surgical procedures. This registry was declared at the commission national informatique et libertés (CNIL) with the number R2015-23
* Patients who undergo adrenal surgical procedures. This registry was declared at the commission national informatique et libertés (CNIL) with the number R2015-24
* Patients who undergo pancreatic and digestive surgical procedures. This registry was declared at the commission national informatique et libertés (CNIL) with the number R2015-26

laurent Brunaud, MD, PhD

Brunaud

laurent Brunaud

This registry aims to collect informations about patients with endocrine tumors (Thyroid, Parathyroid, Adrenal, Endocrine Pancreas, Endocrine Digestive Tube) who undergo endocrine surgical procedures. This registry is part of the Eurocrine Project.

The EUROCRINE project aims to decrease morbidity and mortality of rare endocrine tumours, by means of a pan-European database. Recording and accessing data at the European level, makes it possible to identify these tumours, which cannot be distinguished at local or national level, because of their extreme rarity. Dissemination of results aims to raise clinical standards and reduce differences in practise between clinics and member states, and thereby diminish morbidity and mortality. Comparison of practice and outcomes will be especially interesting for centres wanting to improve their standards to what is currently considered best practice. EUROCRINE will be a key means by which the medical profession, researchers, health policy makers, and not least patients, can benefit from an increase in knowledge related to diagnosis, treatment, and future clinical research in the field of rare endocrine tumours.

samples from tumor specimen. All patients signed a specific and validated form allowing the collection of samples with DNA (CNIL N° DC2014-2114)

Registry of Endocrine Tumors (Thyroid, Parathyroid, Adrenal, Endocrine Pancreas, Endocrine Digestive Tube)

Registre Tumeurs Endocrine - Eurocrine

Dindo-Clavien classification in percentage (%)

Evaluation of sarcopenia using L3 skeletal muscle index (in cm²/m²)

dual-energy x-ray absorptiometry (DEXA) (in T-score unit)

standardized uptake values (SUV tumor / SUV liver ratio)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Blood Vessel Formation in Endocrine Tumors	NCT00923780	Lesions		-	National Institutes of Health Clinical Center (CC)
Efficacy and Safety of Radiofrequency Ablation in Pancreatic Neuroendocrine and Cystic Tumor	NCT02330497	Pancreatic Tumo... Endocrine Tumor Neoplasms, Cyst...	Radiofrequency ...	18 Years - 85 Years	Société Française d'Endoscopie Digestive
Registry of Endocrine Tumors (Thyroid, Parathyroid, Adrenal, Endocrine Pancreas, Endocrine Digestive Tube)	NCT03410394	Endocrine Tumor		-	Central Hospital, Nancy, France

Spots Global Cancer Trial Database for endocrine tumor