Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Neuroendocrine

Carcinoid Tumor

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Gastrointestinal Agents

All Drugs and Chemicals

Lansoprazole

Dexlansoprazole

Proton Pump Inhibitors

Antacids

Anti-Ulcer Agents

Enzyme Inhibitors

lansoprazole

Stan Van Uum, MD PhD

The goal of this study is to compare several methods for measurement of Chromogranin A in their ability to serve as a marker for disease activity in patients with neuroendocrine tumors.

Further, in a subgroup, we will determine if taking a proton pump inhibitor affects Chromogranin A levels.

Patient group: patients with neuroendocrine tumors (active or inactive) Healthy volunteers

Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples

For determination of normal CgA range, we will recruit 60 healthy subjects (30 female, 30 male), in whom a single plasma sample will be obtained for measurement of CgA B For determination of CgA in patients with carcinoid disease (active or inactaive), we wil recruit 200 patients with carcinoid disease from our local neuroendocinre oncology clinic.

To determine the effect of PPI on chromogranin A concentration, we will recruit a subgroup of 12 healthy subjects who will take a bedtime lansoprazole 30 mg for 7 days. Fasting serum samples for CgA will be obtained at day 7 and 1, 2, 4, and 7 days after discontinuation of the PPI.

University of Western Ontario, Canada

Principle investigator

Psychotropic Drugs

Serotonin

5-Hydroxytryptophan

Serotonin Receptor Agonists

Neurotransmitter Agents

5-Hydroxy-Tryptamine

Stan HM Van Uum, MD, PhD

This is a research study looking at the effect of 5-Hydroxy Tryptophan (5-HTP) on urine excretion of 5-Hydroxyindolacetic acid (5-HIAA). 5-HTP is a common over the counter product that is sold in natural food stores and via the Internet. Increased levels of 5-HIAA in the urine can be found in a specific type of cancer, called carcinoid tumor. This study will examine the effect of oral 5-HTP intake on 5-HIAA excretion. Understanding this effect may help to determine which tests should be done in a patient with increased 5-HIAA excretion who's also taking 5-HTP.

5-HTP is a common over the counter product that is sold in natural food stores and via the Internet. It is claimed to improve sleep problems, depression, anxiety, compulsive disorders, restless leg syndrome, migraines, fibromyalgia, and low pain threshold.Increased levels of 5-HIAA in the urine can be a of a specific type of cancer, called carcinoid tumor. Urinary 5-HIAA levels can also be increased by a number of food products and drugs. Oral 5-HTP is not known as a cause of elevation of 5-HIAA in urine. However, recent information suggests that 5-HTP may cause an increase.

In this study we examine the effect of oral 5-HTP intake (100 mg at bedtime for 10 days) on 5-HIAA excretion in the urine, following a prospective, double-blind placebo-controlled study design.

Understanding this effect may help to determine which tests should be done in a patient with increased 5-HIAA excretion who's also taking 5-HTP.

Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Recurrence

Disease Attributes

Prostate adenocarcinoma with Gleason score 6 or less

Prostate adenocarcinoma with Gleason score 7

Prostate adenocarcinoma with Gleason score 8 -10

C. Richard Choo, MD

This is a pilot study to test a hypothesis that a greater increase in serum chromogranin A (CgA) after a definitive radiotherapy (RT) with or without androgen deprivation therapy (ADT) is associated with a higher risk of prostate cancer recurrence after RT. Serum CgA level is measured before the start of RT and/or the start of neoadjuvant ADT for patients undergoing a definitive RT with or without ADT. CgA is also measured at various pre-defined post-RT time points. The study will analyze the followings: 1. Change in CgA level at various pre-defined post-RT time points from the baseline, 2. Correlation between the extent of post-therapy CgA change and Gleason score of malignancy, 3. Correlation between the extent of post-therapy CgA change and treatment outcome.

Neuroendocrine differentiation (NED) in prostate cancer is a well-recognized phenotypic change by which prostate cancer cells transdifferentiate into neuroendocrine-like (NE-like) cells. Accumulated evidences have suggested that the prevalence of NE-like cells is associated with disease progression and poor prognosis.

NED can be induced by a therapeutic agent. Such therapeutic agents include RT and ADT. RT-induced NED represents a novel pathway by which prostate cancer cells survive radiotherapy and contribute to treatment failure and tumor recurrence. Chromogranin A is the serum biomarker for NED and correlates well with CgA-positive staining in biopsy specimens. It has been reported that elevated serum CgA is associated with poor therapeutic response, androgen-independent growth, and biochemical recurrence.

The study tests whether the extent of serum CgA increase by RT +/- ADT, which reflects radiation-induced NED, is correlated with the risk of prostate cancer recurrence following RT and a Gleason score of prostate carcinoma.

Evaluation of Neuroendocrine Differentiation as a Potential Mechanism of Tumor Recurrence Following Radiotherapy

Mayo Clinic

Principal Investigator

Gland and Hormone Related Diseases

Digestive System Diseases

Endocrine Gland Neoplasms

Adenoma

Adenoma, Islet Cell

Endocrine System Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Pancreatic Neuroendocrine Tumor

Non Functioning Pancreatic Endocrine Tumor

Pancreatic Cancer

The plasma level of chromogranin A (CgA) was measured in enrolled patients who was diagnosed as PNET in preoperative condition.After surgical resection, the CgA level was only measured in the the patient with PNET. In the PNET group, the CgA level was regularly checked in a 3, 6, 12, and 24 months after surgical resection.

Chromogranin A

Songcheol Kim, MD PhD

Chromogranin A (CgA) is a glycoprotein with a molecular weight of 49 to 52 kDa produced by chromaffin cells of the adrenal medulla, enterochromaffin-like (ECL) cells, and endocrine cells of the stomach and pancreas, and it is the precursor to several functional peptides including vasostatin and pancreastatin.

Importantly, CgA can be measured in the serum or plasma or detected within the secretory vesicles as a general diagnostic biomarker for neuroendocrine tumors (NETs), and plasma CgA levels also provide information regarding tumor burden and response to treatment. It has a sensitivity and specificity between 27% and 81%.

Some studies have noted an association between CgA concentrations and tumor location or degree of differentiation. It has also been proposed that plasma CgA levels are more frequently elevated in well-differentiated tumors compared with poorly differentiated tumors of the midgut. Some other clinical series have provided evidence of an association between plasma CgA levels and the extent of disease, tumor burden, or presence of metastases, and high baseline levels of CgA are suggestive of a poor prognosis.

However, there exist still controversies the effectiveness of serum CgA levels on diagnostic relevance, treatment response after surgical resection or sandostatin analog, clinicopathologic features of pancreatic neuroendocrine tumors (PNETs).

To date, moreover, a precise association between CgA levels and survival has not been clearly demonstrated, although a number of studies suggest that this relationship may exist. There, especially, is no relevant data on value of serum CgA level for clinical usefulness in Korean population.

An interventional, prospective, multi center pilot study to assess the clinical relevance of CgA levels in patients with PNET as performed in current clinical practice.

There will be a measurement of CgA levels at baseline (preoperative measures after consent) and afterwards, in 3, 6, 12, and 24 months after resection. Immunoradiometric assay (IRMA, normal values: \< 100 ng/mL) will be used.

The collection of blood samples will proceed as detailed below:

Extraction of samples for serum collection:

7 ml of blood without anticoagulants will be allowed to sit for 30 min at room temperature before the serum is separated by centrifugation (3500 rpm). The serum will be stored at -20ºC

Assessments: Baseline (preoperative measures after consent), 3,6, 12, and 24 months

Clinical parameters: weight, height, performance status, vital signs including blood pressure, clinical signs and symptoms, survival data

Blood biochemical parameters: Sodium, potassium, calcium, glucose, urea, creatinina, bilirubin, alkaline phosphatase, aspartate transaminase (AST), and alanine transaminase (ALT).

Computed tomography (CT) : preoperative condition, and 3,6,12,24 months after resection.

Clinical Effectiveness of Serum Chromogranin A Levels on Diagnostic of Pancreatic Neuroendocrine Tumors

Clinical Effectiveness of Serum Chromogranin A (CgA) Levels on Diagnostic Relevance, Response After Surgical Resection and Recurrence of Pancreatic Endocrine Tumors (PET)

In the PNET group, the plasma level of CgA was regularly measured.

In the PNET group, the plasma level of CgA was regularly checked to follow up the status of disease progression.

In the PNET group, the CT was regularly checked to follow up the status of disease progression.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples	NCT01216267	Neuroendocrine ...	Lansoprazole lansoprazole	18 Years - 70 Years	University of Western Ontario, Canada
Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples	NCT01216267	Neuroendocrine ...	Lansoprazole lansoprazole	18 Years - 70 Years	University of Western Ontario, Canada
Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion	NCT00227136	Carcinoid Tumor... Neuroendocrine ...	5-Hydroxy-Trypt...	18 Years -	Western University, Canada
Evaluation of Neuroendocrine Differentiation as a Potential Mechanism of Tumor Recurrence Following Radiotherapy	NCT03017794	Prostate Cancer		18 Years -	Mayo Clinic
Clinical Effectiveness of Serum Chromogranin A Levels on Diagnostic of Pancreatic Neuroendocrine Tumors	NCT02759718	Non Functioning...	Chromogranin A	19 Years - 80 Years	Asan Medical Center
Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples	NCT01216267	Neuroendocrine ...	Lansoprazole lansoprazole	18 Years - 70 Years	University of Western Ontario, Canada
Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion	NCT00227136	Carcinoid Tumor... Neuroendocrine ...	5-Hydroxy-Trypt...	18 Years -	Western University, Canada

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