Gland and Hormone Related Diseases

All Conditions

Neoplasms

Thyroid Diseases

Thyroid Nodule

Endocrine System Diseases

Thyroid Neoplasms

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Under ultrasonography the thyroid nodules will be ablated by radiofrequency ablation

Under USG control, the nodule will be ablated by radiofrequency with a needle that has an active tip of 1 cm.

Radiofrequency ablation of the thyroid nodule

Erhan Aysan, Prof. Dr.

Yeliz Ersoy, Assoc.Prof

Erhan Aysan, Prof

Yeliz Ersoy, Assoc. Prof

ERHAN AYSAN, PROF.

Thyroid nodules are common problems and although \> 95% are stated to be benign, they may cause some problems like hyperthyroidism, compression symptoms, and cosmesis associated with their function, size and localization. Especially for these nodules, patients undergo surgery and face up with the problems associated with surgical complications although they are not cancer. In some studies, radiofrequency ablation previously used for intrabdominal tumors like hepatic metastasis...,was stated to be efficient in the treatment of benign thyroid nodules and in some recurrent thyroid cancer cases. Therefore, the investigators decided to use this method in our patients having nodules like previously mentioned and see the efficacy and safety of the technique.

Radiofrequency Ablation in Thyroid Nodules

Efficacy of Radiofrequency Ablation in Thyroid Nodules

Bezmialem Vakif University

M.D.

"In-person" geriatric consults to be done via telemedicine due to the current pandemic and consideration for patient safety.

The geriatrics service sees these patients for at least 2 postoperative days, if deemed clinically necessary by the geriatrician. During the inpatient hospital course, the geriatrics service will ensure the execution of preoperative recommendations and will discuss with the surgical team, who will act as a primary team, any additional recommendation in order to improve postoperative care. "In-person" geriatric consults to be done via telemedicine due to the current pandemic and consideration for patient safety.

in-person geriatric co-management

Following completion of the eRFA, the summary of impairments as well as the recommendations generated by the study team (hard-copy or email) will be provided in real-time to the surgery team for their attention.

automated geriatric co-management

Armin Shahrokni, MD, MPH

The purpose of this study is to find out if it is possible to use the automated geriatric co-management program to manage the participants care before, during and after surgery.

The proposed study is a randomized controlled trial study.

Automated Geriatric Co-Management Program in Older Patients With Solid Mass or Nodule Suspicious for Cancer

Feasibility and Effectiveness of Automated Geriatric Co-Management Program on Improving the Perioperative Care of Older Patients With Solid Mass or Nodule Suspicious for Cancer

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

percentage of recommendations that were followed by the surgery team

Memorial Sloan Kettering Cancer Center

In-person Geriatric Co-management Group

automated geriatric co-management: Following completion of the eRFA, the summary of impairments as well as the recommendations generated by the study team (hard-copy or email) will be provided in real-time to the surgery team for their attention.

Automated Geriatric Co-management Program Group

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Armin Shahrokni, MD, MPH

Feasibility of Automated Geriatric Co-management Program

Overall Study

Immune System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Hypersensitivity

Multiple Pulmonary Nodules

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Use of cryoprobes and then conventional forceps during the same operating time.

Use of conventional forceps and then cryoprobes during the same operating time.

In this experimental group, the Cryoprobe is used in first and the classic biopsy forceps in a second time. This medical device under study is the flexible, single-use Cryoprobe, supplied in sterile condition, 1.1 mm in diameter, 1150 mm long, with extraction tube, 817 mm long (reference 20402-401), or 757 mm long (reference 20402-402) marketed. These cryoprobes are covered by a CE marking. Cryoprobes must be used in conjunction with the Erbecryo®2 device and its accessories.

Cryoprobes First

In this second experimental group, the same medical devices are used but in the other order.

Cryoprobes Second

In pulmonary oncology, the diagnosis of medium-sized pulmonary nodules (10 to 20 mm), too distal to be reached by standard bronchial fibroscopy but remaining proximal, is difficult.

There are 2 techniques: transthoracic puncture-biopsy under CT scan, usually performed by radiologists, and distal sampling guided by radial ultrasound mini-probe.

The limitations of the last technique could be overcome by the use of cryoprobes for sampling, as they would take more tissue by freezing.

Concerning the interventional pneumology technique, it is performed in two steps: identification of the mass with the mini ultrasound probe and then distal sampling with a small biopsy forceps. Experience shows that there is a significant difference between the identification of the mass, which is fairly conclusive, and the samples, which are much less productive (60% at best), because it is necessary that :

* that the tumor is endo-bronchial,
* that the forceps open sufficiently to take samples by back and forth movements
* but, on the other hand, that the bronchus is not too wide.

The use of cryoprobes would allow to take more tissue by freezing. The target tissue freezes at the tip of the cryoprobe and can be detached by traction. The longer the freezing time, the more tissue is removed.

Various studies of endo-bronchial visible tumor diagnosis have compared these 2 sampling techniques (cryoprobe and conventional biopsy forceps). The cryoextraction technique performed by cryoprobes has a superior diagnostic yield (compared to flexible forceps biopsy) due to large biopsies and superior quality of the biopsied tissue (very few crush artifacts or hematomas; the morphological structure remains intact).

In this context, it seems interesting to compare these 2 techniques but in distal situation, under ultrasound detection with the mini-probes, for tumors not visible in endo-bronchial. The first samples taken in the investigating center by this technique are convincing.

In the framework of this study, in the same operating time and after ultrasound identification of the tumor, biopsies will be performed by conventional forceps (5 samples) and by cryoprobes (3 samples) on the same site. The sequence of use of one or the other technique will be randomly selected. Thus, each patient is his own control.

This first pilot study will explore the feasibility, effectiveness and safety of this procedure. Depending on the results of this comparative study, a second study including more patients will validate this procedure.

This is a clinical investigation of a CE (Communauté Européenne)-marked medical device that is monocentric, interventional, prospective, comparative, randomized, open-label, with cross-over design.

Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules

Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules Using Cryoprobes Versus Standard Biopsy Forceps During Distal Sampling Guided by Mini Radial Ultrasound Probes

Histological diagnosis from the material collected by cryoprobes and conventional forceps

specificity, sensitivity, predictive values

Collection of adverse events for the duration of the study.

Elsan

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

For: Dose escalation phase/Phase II Expansion Phase. Cohorts of 3-6 patients were to be enrolled sequentially until an MTD or a recommended Phase II dose were defined. All patients were to receive the combination treatment. Sequential cohorts may receive different doses of the combination. In the Phase II expansion, all patients were to receive the same combination treatment.

BYL719 is a small molecule inhibiting PI3-Kinase.

BYL719

AMG 479 is a monoclonal antibody directed against IGF1-R.

AMG 479

Novartis Pharmaceuticals

This was a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part was to estimate the MTD(s) and/or identify the recommended phase II dose(s) (RP2Ds) for the combination of BYL719 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. Patients were to be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. All patients were to be followed up. At a minimum, patients must have completed the safety follow-up assessments 30 days after the last dose of the study treatment.

This was a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part was to estimate the MTD(s) and/or identify the recommended phase II dose(s) (RP2Ds) for the combination of BYL719 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. The dose escalation part of the study were to be guided by a Bayesian Logistic Regression Model (BLRM).

Once MTD/RP2D had been determined, patients were to be enrolled in two Phase II arms. Patients with PIK3CA mutated or amplified hormone receptor positive breast carcinoma were to be enrolled in Arm 1; patients with PIK3CA mutated or amplified ovarian carcinoma were to be enrolled in Arm 2. Patients were to be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. All patients were to be followed up. At a minimum, patients must have completed the safety follow-up assessments 30 days after the last dose of the study treatment.

A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

The antitumor activity of alpelisib in combination with ganitumab in patients with PIK3CA mutated or amplified hormone receptor positive (HR+) breast (arm 1) or ovarian (arm 2) cancer.

Overall response rate is defined as the proportion of patients who have a best overall response of complete response or partial response assessed per RECIST 1.1.

The anti-tumor activity of alpelisib and ganitumab in combination as per RECIST 1.1

the antitumor activity of alpelisib in combination with ganitumab in patients with PIK3CA mutated or amplified hormone receptor positive (HR+) breast (arm 1) or ovarian (arm 2) cancer.

Phase II only, Cycle 1 Day 1 through Cycle 6 Day 28; assessed at baseline and every 8 weeks thereafter

Serum concentration for BYL719 (alpelisib)

1 cycle - 28 days of treatment

Area under curve for BYL719 (alpelisib)

1 cycle - 28 days of treatment

Tmax and half life of BYL719 (Alpelisib)

1 cycle - 28 days of treatment

Serum concentration for AMG 479 (ganitumab)

1 cycle - 28 days of treatment

Area under curve for AMG 479 (ganitumab)

1 cycle - 28 days of treatment

Tmax and half life of AMG 479 (ganitumab)

1 cycle - 28 days of treatment

NantCell, Inc.

One patients with a tumor type other than Breast and Ovarian treated in the phase II part not represented.

BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors

BYL 200mg + AMG 12 mg/kg

BYL 300mg + AMG 12 mg/kg

BYL 350mg + AMG 12 mg/kg

Patients with PIK3CA mutated or amplified hormone receptor (HR) positive breat carcinoma (BC) were treated with alpelisib 300 mg once daily and ganitumab 12 mg/kg

HR + BC - Phase II

Patients with other than Breast and Ovarian cancer treated in the phase II

Ovarian - Phase II

BYL 200mg + AMG 12mg/kg

BYL 300mg + AMG 12mg/kg

BYL 350mg + AMG 12mg/kg

Patients with PIK3CA mutated or amplified hormone receptor (HR) positive breast carcinoma (BC) were treated with alpelisib 300 mg once daily and ganitumab 12 mg/kg.

HR+BC - Phase II

Patients with PIK3CA mutated or amplified ovarian cancer were treated with alpelisib 300 mg once daily and ganitumab 12 mg/kg

Patients with other than Breast and Ovarian cancer treated in the phase II part

Non-HR+BC/Ovarian - Phase II

Race/Ethnicity, Customized

Due to the competitive landscape for anticancer therapies in ovarian and breast cancer and given the limited clinical activity observed with the study combination treatment, Novartis decided in 2014 to halt the recruitment in the trial.

Study Director

Drug hypersensitivity

Hyperglycemia

Rash maculopapular

Urticaria

Dose determining set (DDS): DDS includes all patients from the safety set who either met the minimum treatment exposure and safety evaluation requirements without experiencing DLT within Cycle 1 or experienced a DLT at any time during Cycle 1.

Dose Limiting Toxicities (DLTs) - Phase Ib

The total column "All patients" includes a patient with non-HR+BC and non-Ovarian cancer treated in the Phase II part.

All Patients - Phase

Full analysis set (FAS). The full analysis set (FAS) includes all patients who received at least one full or partial dose of alpelisib or ganitumab. Patients were analyzed according to the planned treatment combination.

Percentage of Patients With Overall Response Rate (RECIST) Based on Investigator Radiology Assessment for HR Positive Breast and Ovarian Cancer - Phase II

Complete response (CR)

Partial response (PR)

Stable disease (PD)

Progressive disease (PD)

Unknown

Number of Patients With Best Overall Response (RECIST) Based on Investigator Radiology Assessment - Phase Ib

Percentage of Patients With Disease Control Rate (RECIST) Based on Investigator Radiology Assessment - Phase Ib

All Patients - Phase II

Percentage of Patients With Disease Control Rate (RECIST) Based on Investigator Radiology Assessment for HR Positive Breast and Ovarian Cancer - Phase II

Cycle 1 Day 1

Cycle 1 day 15

Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received.

Cmax of BYL - Phase Ib

Area Under Curve (AUC) 0-24 Hour of BYL - Phase Ib

Tmax (Cycle 1 Day 1)

Tmax (Cycle 1 Day 15)

Thalf (Cycle 1 Day 1)

Thalf (Cycle 1 Day15)

Tmax and T Half of BYL - Phase Ib

Cmax of AMG - Phase Ib

Area Under Curve (AUC) 0-336 Hour of AMG - Phase Ib

Tmax

Thalf

Tmax and T Half of AMG - Phase Ib

Carcinoma

In this group, patients willingly receive CT-guided percutaneous radiofrequency ablation procedures are selected according to the inclusion criteria as follows. After a series of preoperative evaluation and preoperative preparation，the procedures will be performed under the CT guidance. CT/MRI scans will be ordered after 24-48 hours to see if there are complications (such as haemorrhage, pneumothorax and pleural effusion). Regularly follow-up will be carried out for several years after RFA to assess the effectiveness and safety of RFA integratedly.

Percutaneous radiofrequency ablation (RFA) is a minimally invasive technique will be performed in patients with malignant pulmonary nodules in this group. RFA kills the tumors by causing coagulation necrosis via tissue heating. The electrode delivers thermal energy will be inserted into the target tissues under the CT guidance to ensure the area of ablation should cover the targets and the lung tissues 0.5-1.0 cm around the tumors. Post-operative scan and laboratory test will be conducted in time.

CT-guided percutaneous radiofrequency ablation

Yueyong Xiao

The objective of this study is to evaluate the outcomes of radiofrequency ablation in the treatment of patients with malignant pulmonary nodules（not exceed 3cm ）who are not suitable candidates for or refuse surgical resection.

Percutaneous radiofrequency ablation (RFA) is a minimally invasive technique widely used to treat solid tumors. Patients with malignant pulmonary nodules will undergo a series of CT- guided percutaneous RFA procedures. During the procedures，percutaneous needles will be inserted into the target tissues under CT guidance，the needles deliver thermal energy and then destroy the tumors by causing coagulation necrosis via tissue heating. The purpose of this study is to assess the effectiveness and safety of RFA in pulmonary nodules （maximum tumor diameter ≦30 mm） was 10 mm apart from the big trachea, primary bronchi, esophagus, great vessels，heart and pleura. Preoperative and postoperative evaluations，including recent laboratory tests evaluated and imaging studies reviewed，will be performed both before and after the procedures.

Radiofrequency Ablation of Malignant Pulmonary Nodules

Efficacy and Safety of Radiofrequency Ablation of Malignant Pulmonary Nodules

Including puncture-related complications such as pulmonary haemorrhage, hemothorax, pneumothorax, cardiac tamponade, and air embolism and ablation-related complications such as chest pain, pleural reactions, cough, and skin burns.

Changes in imaging findings in the ablation zone

Chinese PLA General Hospital

Director of the Department

Kuen-Yuan Chen, MD

Kuen Yuan Chen, MD

In the outpatient clinic based population setting, the investigators want to reappraise the accuracy of the new model of multi-factorial ultrasound diagnosis with the conventional fine-needle aspiration cytology.

4 to 7 percent of adult population has a palpable thyroid nodule and 17% to 27% of cases can be found when examined by sonography. Although the incidence of the thyroid nodules is high, only 1 of 20 clinically identified nodules is malignant.

Several gray scale sonographic characteristics have been suggestive of malignancy, including hypoechoigenicity, micro calcification, blurred margin and intranodular vascularity. The intranodular vascularity has been studied in several researches. But the previous studies usually evaluated the vascularity by color Doppler sonography and only divided into several categories subjectively. And the result is controversial.

The evaluation of the tumor microcirculation by Doppler ultrasound has been used in many tumors and defined as vascularity index (VI). The power Doppler sonography has many advantages over color Doppler ultrasound in studying the vascularity. It is more sensitive, less noisy. Power Doppler can detect the blood flow of small internal tumor vessels with a diameter of less than 100μm at slow flow rates on the order of a few mm per second1,2 According to our previous study, the vascularity index(PDVI) of thyroid tumor by power Doppler ultrasound between benign and malignant one are statistically different.

In the present study, the investigators examine different PDVI of thyroid tumors and the traditional（B-mode）ultrasound features including the heterogeneity, echogenicity, margin status, and the presence of microcalcification. The investigators consider the several factors simultaneously by statistical model (PCA, FLD). In the outpatient clinic based population setting, the investigators want to reappraise the accuracy of the new model of multi-factorial ultrasound diagnosis with the conventional fine-needle aspiration cytology.

Thyroid Disease Diagnosis by Mutiple Ultrasonic Factors.

Diagnosis of Thyroid Tumors by Multiple Ultrasonic Factors.

Patients who were eligible for this trial will receive the new model of ultrasound evaluation . The traditional features including echogenicity, margin, heterogeneity, size and the presence of microcalcification will be recorded in the same time. Then the investigators evaluate the thyroid tumor vascularity in sagittal and transverse section by power Doppler mode (wall filter (WF): medium, colour power angiography (CPA): 82, retroperitoneal fibrosis (RPF): 1000). The DICOM data of the vascularity index(PDVI) will be collected and analyzed later.

National Taiwan University Hospital

Patients undergoing lung segmentectomy through a mini thoracotomy

VATS

Mini muscle sparing thoracotomy for lung segmentectomy

Mini thoracotomy

Aim of this prospective randomized study is to assess the safety and efficacy of video-assisted lung segmentectomy (Group B) comparing with mini muscle-sparing thoracotomy (group A) during diagnostic process for pulmonary nodules.

Fast Track Rehabilitation Following Video-assisted Lung Segmentectomy

Theagenio Cancer Hospital

Head of Thoracic Surgery Department

Patients with thyroid cancer or benign thyroid disease (nodules or goiter) who underwent thyroidectomy and/or neck dissection as standard of care.

Kathryn G. Schuff, M.D.

The purpose of this study is to evaluate how common gene mutations are in benign and malignant thyroid lesions.

The overall objective of this study is to evaluate the prevalence of molecular markers in patients with benign and malignant thyroid lesions. This study consists of:

Retrospective review of archived surgical pathology specimens at Oregon Health \& Science University (OHSU) from patients with thyroid cancer or benign thyroid disease (nodules or goiter) who underwent thyroidectomy and/or neck dissection as standard of care. Molecular markers will be evaluated on archived tissue.

Molecular markers will be correlated with clinical information extracted from OHSU medical records: histologic subtype of cancer, measures of tumor aggressiveness (capsular and angiolymphatic invasion, local invasion, lymph node and distant metastases, TNM stage(TNM Classification of Malignant Tumours)) and clinical outcome (recurrence, distant metastases and death).

Patients with other malignancies presenting for standard of care services will have peripheral blood collected for DNA, RNA and buffy coat/white blood cells as a "positive" control for the DNA/RNA isolation techniques and mutation assays, as other cancers commonly express some of the same mutations. Normals will have peripheral blood collected for DNA, RNA and buffy coat/white blood cells as a "negative" control for the DNA/RNA isolation techniques and mutation assays.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiofrequency Ablation in Thyroid Nodules	NCT01750593	Thyroid Nodules	Radiofrequency ...	18 Years - 70 Years	Bezmialem Vakif University
Automated Geriatric Co-Management Program in Older Patients With Solid Mass or Nodule Suspicious for Cancer	NCT03885908	Cancer	in-person geria... automated geria...	65 Years -	Memorial Sloan Kettering Cancer Center
Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules	NCT05230992	Nodule	Cryoprobes Firs... Cryoprobes Seco...	18 Years -	Elsan
A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors	NCT01708161	PIK3CA Mutated ... PIK3CA Amplifie...	BYL719 AMG 479	18 Years -	Novartis
Radiofrequency Ablation of Malignant Pulmonary Nodules	NCT02629978	Neoplasms Carcinoma	CT-guided percu...	-	Chinese PLA General Hospital
Thyroid Disease Diagnosis by Mutiple Ultrasonic Factors.	NCT04388956	Thyroid Nodule Diagnoses Disea...		-	National Taiwan University Hospital
Fast Track Rehabilitation Following Video-assisted Lung Segmentectomy	NCT01397045	Multiple Pulmon...	VATS Mini thoracotom...	- 80 Years	Theagenio Cancer Hospital
Molecular Markers in Thyroid Cancer	NCT00598364	Thyroid Cancer		1 Year -	OHSU Knight Cancer Institute

Spots Global Cancer Trial Database for nodule

Every month we try and update this database with for nodule 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 nodule

Every month we try and update this database with for nodule 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 nodule 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.