Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Immune System Diseases

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Obesity

Syndrome

Hypersensitivity

Metabolic Diseases

Weight Loss

Polycystic Ovary Syndrome

Body Weight

Noncommunicable Diseases

Overweight

Overnutrition

Nutrition Disorders

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Insulin

Insulin, Globin Zinc

All patients who participate in the study will be recruited to the Intervention Arm and will undergo the STREAM program, a 24-week weight loss program which includes meal replacement, dietician teaching and regular appointments with their bariatric medicine specialist.

The STREAM program is a 24-week weight-loss program which includes meal replacement, dietician coaching/teaching and weekly visits with a physician.

STREAM program

Judy Shiau, MD

Lesley Ananny, BA

Julie Laroche

The goal of this clinical trial is to study the effects of a intensive weight loss program (STREAM) in patients living with PCOS. The main questions the investigators aim to answer are: how much weight will these patients lose over a 24-week program, and what other health markers (ie., insulin sensitivity) will improve and by how much?

Participants will complete a 24-week weight loss program (STREAM). During this program they will:

* weigh themselves
* complete regular bloodwork and
* fill out a Quality of Life questionnaire at regular intervals

Polycystic ovary syndrome is a common disorder affecting up to 20% of women of reproductive age associated with, but not exclusive to, obesity. Excess weight and especially visceral adiposity lead to increased insulin resistance which in turn will promote decreased SHBG concentrations and excess androgen secretion from the ovaries. Weight-loss is known to improve PCOS symptoms in individuals but threshold of weight-loss needed to achieve improvement in many PCOS outcomes is poorly understood, as is the impact of varied weight-loss strategies employed to promote weight loss.

OBJECTIVE The goal of this study is to understand the effects of increasing weight loss thresholds on multiple PCOS symptoms and features, using a 24-week intensive weight loss program (STREAM) with the possibility of added pharmacotherapy for weight loss when indicated.

RESEARCH QUESTION What is the required weight loss to achieve significant improvement in PCOS outcomes including metabolic, endocrine, fertility and mental health parameters? Is there a difference in outcome improvement from different approaches (meal replacement, adjunct pharmacotherapy), independent from weight-loss?

PRIMARY OUTCOMES

To identify the percentage of bodyweight loss needed to achieve significant improvement in each of the following:

* Endocrine parameters (SHBG, Testosterone, Androstenedione, LH/FSH ratio)
* Insulin sensitivity (HOMA-IR)
* Lipid profile (TG, HDL and Non-HDL levels)
* Liver enzyme profile (ALT)
* Menstrual cyclicity (yes/no)
* Quality of life scale (QOLS-public domain, see annex)

STUDY DESIGN Participants will be recruited from those already referred to the LEAF Clinic. Women over the age of 18 who meet the inclusion criteria will be invited to participate in the STREAM program, a 24-week intensive weight-loss program that includes full and partial meal replacement, dietician group coaching and weekly meetings with a weight-loss specialist physician. The program cost, $2250, will be waived for the purpose of limiting sampling bias as the cost can be untenable for many patients.

DATA COLLECTION Participants will complete PCOS-specific blood tests at the launch of the program, at the end of the 24 weeks and then again at 6 months after the program is finished. They will also be asked to complete the same blood draws at every 5% weight loss from their baseline. Participants will also be asked to complete the Quality of Life Scale (QOLS), a short survey, at the same intervals.

ANTICIPATED RESULTS Learning more about individual variations in outcome improvement with gradual weight loss in a population of women living with PCOS will be helpful in individualizing approaches to weight loss in this population. This study could not only help determine predictors of improvement for each outcome but as well identify weight loss strategies that are more efficient for specific outcomes. This will result in better care for women living with PCOS.

Clinic patients with PCOS will be recruited to participate in a 24-week weight loss program. They will all receive the program. There is no control group.

Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity

Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity - A Prospective Study Using a Multi-disciplinary Multi-modal Approach to Weight-loss

There is no plan to share IPD with other researchers at this time and we are not seeking permission to do so from our research ethics board.

percentage difference in participant weight

Change in blood test results (SHBG, Testosterone, Androstenedione, LH/FSH ratio) which are all endocrine markers of PCOS

Change in blood test results (HOMA-IR) which is a marker of PCOS

Change in blood test results (TG, HDL and Non-HDL levels) which are markers of PCOS

Change in blood test results (ALT) which is a marker of PCOS

QoLs is a public-domain questionnaire measuring several subjective quality-of-life parameters

LEAF Weight Loss Clinic

Ottawa Hospital Research Institute

Nervous System Diseases

Adenoma

Pituitary Diseases

Pituitary Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Hormones

The first group of subjects, Group I, will be followed in Protocol I and are a group of subjects with an apparent clinically nonfunctioning pituitary lesion who will be studied in a prospective study of conservative non-surgical management.

A second group of subjects, Group II, are subjects who are undergoing surgical intervention for CNFA or radiotherapy for CNFA and these subjects will be studied in a prospectively follow up as part of Protocol II.

Surgical intervention for CNFA

Radiotherapy for CNFA

Carlos M Reyes-Vidal, MD

Wayna Paulino, MD

Krystal Hernandez, MD

Pamela U. Freda, MD

Sharon L Wardlaw, MD

Jeffrey N Bruce, MD, FACS

Yaakov Stern, PhD

This project is the first comprehensive prospective study of clinically non-functioning pituitary adenomas (CNFAs). Two groups of subjects will be studied: Group I will consist of 100 patients with clinically non-functioning (CNF) pituitary lesions who are asymptomatic and do not require surgery; Group II will consist of 250 patients who have pituitary lesions that are symptomatic and require surgery. Patients will be followed with a series of endocrine laboratory testing, physical examinations, testing of quality of life and neurocognitive function before and serially over time either during non-surgical management or after surgery and in some patients before and after radiotherapy (RT). Data on pituitary magnetic resonance imaging (MRI) studies and visual field testing being done over time during follow up as part of clinical care will be collected.

PROTOCOL I: Prospective Study of the outcome of conservative non-surgical management of patients with asymptomatic, clinically non-functioning (CNF) pituitary lesions. This protocol will evaluate prospectively the outcome of non-surgical management of clinically non-functioning pituitary lesions that do not appear to need surgery as their initial therapy. The overall design consists of an initial baseline evaluation and then serial prospective follow up studies over time for up to 5 years of follow up. The study will evaluate laboratory testing, clinical examinations, quality of life and neurocognitive function in these patients. Data will be collected on visual fields and MRI studies of the pituitary tumor that are done prospectively as part of clinical care to evaluate these patients.

PROTOCOL II : Prospective study of the outcome of patients with symptomatic, clinically non-functioning pituitary tumors who are treated with transsphenoidal surgery and in some cases also radiotherapy. This protocol will evaluate prospectively the outcome of surgical management of asymptomatic clinically nonfunctioning pituitary lesions. The overall design consists of an initial baseline evaluation and then serial prospective follow up studies over time with up to 5 years of follow up. The study will evaluate laboratory testing, clinical examinations, quality of life and neurocognitive function in these patients. Data will also be collected on visual fields and MRI studies of the pituitary tumor that are done prospectively as part of clinical care to evaluate these patients. Data will be analyzed to determine the safety of observation alone following surgery for patients who do not have a clinically significant tumor remnant, if the silent corticotroph tumor type is characterized by elevated plasma levels of ACTH or its precursor, POMC, and if it is associated with an increased tumor recurrence rate. A group of patients who are planning RT will also be studied by these same procedures before and after RT in order to determine if the outcomes of patients who receive RT for treatment of tumor re-growth to that of those who do not receive RT with respect to further tumor growth, endocrine or neurological dysfunction. Quality of life and neurocognitive function in patients with clinically non-functioning pituitary lesions treated with surgery alone or those who also receive radiotherapy will be prospectively assessed.

Prospective Study of Clinically Nonfunctioning Pituitary Adenomas

Neurocognitive function change over the time frame of the study

National Institute of Neurological Disorders and Stroke (NINDS)

Columbia University

Professor of Medicine

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Neuroendocrine

Pancreatic Neoplasms

Neuroendocrine Tumors

Carcinoid Tumor

Carcinoma, Islet Cell

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Pancreatic Cancer

Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

Gastrointestinal Agents

Anti-Infective Agents

Everolimus

Octreotide

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Hormonal

Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day.

Stratum 2 patients who were to receive everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot therapy.

Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.

Participants took two 5 mg tablets of Everolimus orally with a glass of water, once daily (preferably in the morning) in a fasting state or after no more than a light, fat-free meal. Dosing was to occur at the same time each day. If vomiting occurred, the vomited dose was not to be replaced.

Everolimus 10 mg

Octreotide Depot

Novartis Pharmaceuticals

The purpose of this study was to assess the efficacy and safety of everolimus in the treatment of advanced pancreatic neuroendocrine tumor (NET) not responsive to cytotoxic chemotherapy. All patients were treated with everolimus until either tumor progression was documented using a standard criteria that measures tumor size called Response Evaluation Criteria in Solid tumors (RECIST), or until unacceptable toxicity occurred, or until the patient or investigator requested discontinuation of treatment.

This was a stratified two-stage, single-arm, phase 2 study of treatment with everolimus in patients with advanced (unresectable or metastatic) pancreatic neuroendocrine tumor (NET) after failure of cytotoxic chemotherapy.

Stratum 1, consisted of patients not receiving chronic Octreotide Depot therapy, will receive everolimus monotherapy at 10 mg/day.

Stratum 2, consisting of patients with tumors that have progressed during Octreotide Depot treatment will continue their entry dose of Octreotide Depot plus everolimus 10 mg/day.

Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy

An Open Label, Stratified, Single-arm Phase II Study of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumor (NET) After Failure of Cytotoxic Chemotherapy

Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.

Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR):

* Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression.
* Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.

Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions

Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed.

Median PFS was obtained and displayed along with 95% confidence intervals.

Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause.

If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed.

For all patients in both strata, a blood sample for everolimus trough level determination will be collected immediately prior to the everolimus administration on Cycle 1 Day 15, Cycle 2 Day 1, and every month thereafter. A treatment cycle was defined as 28 days of consecutive daily treatment with everolimus and treatment continued until tumor progression. It is critical that patients not take their daily everolimus dose before the sample is drawn.

The effect of Octreotide Depot on the trough concentrations of everolimus was assessed at Cycle 1 Day 15.

Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.

Stratum 1: Everolimus 10 mg

Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.

Stratum 2: Everolimus 10 mg + Octreotide Depot

Total

Age Continuous

Sex: Female, Male

Novartis Study Director

The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.

Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)

Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus. Only those patients whose best overall response was complete response (CR) or partial response (PR) were included in this analysis.

Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review

Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.

Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.

Very low number of patients demonstrated a partial response, the median duration of response as per central review has not been calculated.

Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review

Full Analysis Set (FAS) was consisted of all patients who received at least one dose of everolimus.

Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)

Adverse Events

Death

Serious Adverse Events

The safety population consists of all patients who received at least one dose of everolimus and had at least one post-baseline safety assessment.

Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1]

Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2]

Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1)

Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2)

The full analysis set consisted of all patients who received at least one dose of everolimus.

Time to Overall Survival (OS)(Stratum 1)

Time to Overall Survival (OS) (Stratum 2)

Full Analysis Set (FAS) is consisted of all patients who received at least one dose of everolimus. Patients with everolimus pharmacokinteic samples, with nonzero concentration, at Cycle 1 Day 15 were included

Everolimus Trough Level Determination by Pharmacokinetics Parameter in Both Strata (Stratum 1 and 2)

Cycle 1 Day 1 (pre-treatment baseline) (n=37)

Cycle 2 Day 1 (n= 38)

Full Analysis Set (FAS) is consisted of all patients who received at least one dose of everolimus. Patients with Octreotide Depot pharmacokinetic samples, with nonzero concentration, at Cycle 1 Day 1 or Cycle 2 Day 1 were included.

Effect of Octreotide Depot on the Trough Concentrations of Everolimus

Overall Study

Pasireotide

Hormone Antagonists

pasireotide LAR

Peter J. Snyder, MD

The purpose of this study is to determine if administration of pasireotide LAR for one year to three patients with gonadotroph adenomas and elevated serum FSH concentrations will reduce the serum follicle-stimulating hormone (FSH) to normal and reduce the adenoma size.

Gonadotroph adenomas are the most common pituitary macroadenomas. Currently no medical treatment as been found that decreases the size of these adenomas, so surgery is the only treatment. The reason to think that pasireotide might affect gonadotroph adenomas is that pasireotide binds avidly to somatostatin subtype 5 receptors, and gonadotroph adenomas express these receptors. For this study, three subjects who have gonadotroph adenomas, as judged by a macroadenoma of the pituitary and elevated serum FSH concentration, will be treated with a long-acting form of pasireotide once a month for one year. The effect of pasireotide on the size of the adenoma will be determined by MRI, and FSH secretion will be judged by the serum concentration.

Effect of Pasireotide Long Acting Release (LAR) on Gonadotroph Adenomas

Effect of Pasireotide LAR on Gonadotroph Adenomas: A Pilot Study

MRI of the pituitary will be performed at baseline, Month 6 and Month 12 to demonstrate a decrease of ≥3 mm in at least two of three dimensions on MRI (cephalocaudal, transverse, and posterior-anterior). The outcome measure is defined as the number of participants who demonstrated a ≥3 mm decrease in adenoma size in two dimensions.

Serum FSH (mIU/mL) will be measured at baseline and then monthly for the 12 months of the study to determine if serum FSH concentrations decrease by 20%.

University of Pennsylvania

Pasireotide LAR

Age, Categorical

United States

Region of Enrollment

patients with a gonadotroph adenoma

This trial was terminated due to difficulty in identifying 3 subjects for completion of the study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity	NCT06325449	Polycystic Ovar... Obesity	STREAM program	18 Years - 99 Years	Ottawa Hospital Research Institute
Prospective Study of Clinically Nonfunctioning Pituitary Adenomas	NCT01556230	Pituitary Adeno... Pituitary Tumor	Surgical interv... Radiotherapy fo...	18 Years -	Columbia University
Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy	NCT00363051	Islet Cell Carc... Neuroendocrine ... Neuroendocrine ... Pancreatic Neop...	Everolimus 10 m... Octreotide Depo...	18 Years -	Novartis
Effect of Pasireotide Long Acting Release (LAR) on Gonadotroph Adenomas	NCT00929669	Gonadotroph Ade...	pasireotide LAR	18 Years -	University of Pennsylvania
Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity	NCT06325449	Polycystic Ovar... Obesity	STREAM program	18 Years - 99 Years	Ottawa Hospital Research Institute
Lapatinib and Trastuzumab With or Without Endocrine Therapy	NCT00548184	Breast Cancer	Lapatinib Trastuzumab Endocrine	18 Years - 65 Years	Baylor Breast Care Center
Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors	NCT00609765	Pancreatic Canc...	Avastin Fluorouracil Doxorubicin Streptozocin Dexamethasone Ondansetron	18 Years - 80 Years	H. Lee Moffitt Cancer Center and Research Institute
A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.	NCT01602380	Hormone Recepto...	faslodex 500mg arimidex 1mg faslodex dummy arimidex dummy	18 Years - 130 Years	AstraZeneca
Effect of Pasireotide Long Acting Release (LAR) on Gonadotroph Adenomas	NCT00929669	Gonadotroph Ade...	pasireotide LAR	18 Years -	University of Pennsylvania

Spots Global Cancer Trial Database for endocrine

Every month we try and update this database with for endocrine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for endocrine

Every month we try and update this database with for endocrine cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for endocrine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.