Behaviors and Mental Disorders

All Conditions

Neoplasms

Rare Diseases

Financial Stress

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Stress, Psychological

Behavioral Symptoms

Quality of Life

Neuroendocrine Tumor

Neuroepithelioma

Stefano Partelli, Professor

The aim of this study is to evaluate the financial toxicity reported by Italian patients affected by GEP-NEN during the first year of treatment after diagnosis and its correlations with patient-reported outcomes (PROs) and quality of life (QoL).

Gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN) are rare tumours whose incidence has increased during the years. However, referral centers specialized in diagnosis and treatment of these diseases are few. So, patients may be forced to travel long distances in order to reach a disease specialized center (ENETS certification) to plan the correct management and receive the better treatment. On the other hand, patients could research different clinical consulting by several medical specialists without clear indication. Moreover, today also advanced disease allows the patients a good prognosis with long survival. The resulting emotional and psychological burden may contribute to the worse quality of life. Therefore, patients with GEP-NEN have a deal with the financial consequences related to the diagnosis and treatment of their disease including out of pocket costs, loss of income and caregiver burden. Financial toxicity, defined as subjective financial concerns of cancer and objective financial consequences, has been investigated in this study in Italian patients affected by GEP-NEN

Financial Toxicity and Patient-Reported Outcomes in GEP-NEN During Treatment

Financial Toxicity and Patient-Reported Outcomes in Italian Patients Affected by Gastroenteropancreatic Neuroendocrine Neoplasms (GEP-NEN)

Financial toxicity measured by Comprehensive Score for financial toxicity (COST) and out of pockets.

Evaluate the QoL of patients affected by GEP-NEN, as measured by the Questionnaires assessing the QoL of Cancer Patients (QLQ-C30)

Massimo Falconi

Head od Pancreatic Surgery Unit

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Renal Cell

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Sunitinib

Interferons

Interferon-alpha

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

advanced renal cell cancer patients treated with sunitinib as first-line therapy

sunitinib 50 mg, per os, daily for 4 weeks then 2 weeks pause, duration months

sunitinib

Patient receiving sunitinib according the clinician's independent decision as first-line treatment of advanced renal cell carcinoma (RCC) will be asked for informed consent. Treatment with sunitinib will start and end solely on the treating clinicians and the patients independent discretion. Consenting patients will prospectively answer standardized quality of life questionnaires (15D, EQ-5D) during the treatment. Data on health care resource utilisation will be collected prospectively (outpatient visits, hospital stays, concomitant drugs, investigations, sick-leaves, travels). In addition, after treatment failure anti-cancer drugs, hospital stays and date of death will be recorded.

The health economic data during sunitinib treatment and the length of the sunitinib treatment will be compared with the corresponding previously published data collected retrospectively from patients with the same condition treated with IFN-alfa. Stepwise regression analysis will be used to explore whether patient and tumor characteristics explain potential variation in treatment duration and costs that is not explained by the treatment.

Health-related quality of life (HRQoL) data will be presented as descriptive data and compared to age-standardized general population.

At least four major Finnish oncology centers have consented to participate in this study. The inclusion time will be approximately 24 months, and the study time approximately 48 months. Eighty patients will be included.

Evaluation of the Cost and Effectiveness Sunitinib Compared to Interferon-Alfa in Finland

Evaluation of the Cost and Effectiveness in the First-line Treatment of Advanced Renal Cell Cancer With Sunitinib Compared to Interferon-alfa in Finland.

University of Turku

Oulu University Hospital

Pirkko-Liisa Kellokumpu-Lehtinen

Prof

Blood and Lymph Conditions

Symptoms and General Pathology

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

A cohort of adult patients with CML who were treated with TKIs were identified using the IBM® MarketScan® Commercial and Medicare Supplemental databases (commercial claims; the MarketScan database)

The study included patients with CML who were previously treated with TKIs, who are relapsed/refractory to/intolerant of TKIs on third or later lines of therapy in the US.

Tyrosine Kinase Inhibitors (TKIs)

Novartis Pharmaceuticals

Retrospective, non-interventional observational cohort study conducted among patients with CML.

A retrospective, non-interventional cohort study was used to address the study objectives. A cohort of adult patients with CML who were treated with TKIs were identified using the IBM® MarketScan® Commercial and Medicare Supplemental databases (commercial claims; the MarketScan database) to have a better understanding of real-world treatment patterns, HRU and healthcare costs among patients with CML treated with later lines of therapy (i.e., third line or later).

For Phase I, the IBM® MarketScan® Commercial Claims and Encounters and Medicare Supplemental Databases were used (commercial claims). The commercial claims covered the period from 01/01/2001 to 06/30/2019.

The study consisted of the following periods:

* The baseline period was defined as the 6-month period before the first line therapy initiation for CML.
* The observation period was defined as the period of at least 12 months from the first CML diagnosis to the end of data availability or end of health plan coverage, whichever occurs first; the observation period varied by patient.

Study Conducted Among Patients With CML

Real-World Treatment Patterns, Healthcare Resource Utilization and Associated Costs Among Patients With Chronic Myeloid Leukemia in Later Lines of Therapy

Number of patients across all lines of therapy were reported to evaluate treatment sequences among the patients.

Number of patients with the use of pre-treatment hydroxyurea were reported to evaluate treatment patterns in patients.

Number of patients Treatment received and initial dose at each line were reported to evaluate treatment patterns in patients.

Number of patients as per the calendar year of line of therapy initiation were reported to evaluate treatment patterns in patients.

Duration of the line of therapy was reported to evaluate treatment patterns in patients.

Treatment-free period among those with an observed subsequent line of therapy was reported to evaluate treatment patterns in patients.

Number of patients who discontinued treatment were reported to evaluate treatment patterns in patients.

Number of patients: All cause Health Resource Utilization were reported to estimate HRU among patients with three lines of therapy or more.

Healthcare costs among patients with three lines of therapy or more were reported.

Prevalence was defined as the number of cases alive per year of patients with CML who were currently or previously treated on later lines of therapy (third line or later), by calendar year from 2006 to 2018

Healthcare costs among patients with earlier lines of therapy were reported.

Number of patients: All cause Health Resource Utilization among patients with earlier lines of therapy were reported.

Gland and Hormone Related Diseases

Thyroid Neoplasms

Thyroid Diseases

Thyroid Cancer, Papillary

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Papillary Thyroid Carcinoma

Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated with the Ultrasonic coagulation device (Harmonic ACE® Scalpel) and the bipolar energy sealing system (LigaSure Precise) during Conventional Thyroidectomy

Ultrasonic coagulation device (Harmonic ACE® scalpel)

bipolar energy sealing system (LigaSure Precise)

Ja Seong Bae, MD,phD

The aim of the study is to evaluate differences between use of Ultrasonic Coagulation Device (New Harmonic ACE™, Ethicon endo-surgery) and Bipolar Energy Sealing System (LigaSure Precise™, Covidien) in surgery for thyroid cancer.

Abbreviations: Ultrasonic Coagulation Device (UC), Bipolar Energy Sealing System (BES), Recurrence-free survival (RFS), Overall survival (OS)

Background: Thyroid is an organ that has abundant vessels. In thyroid surgery, it should be cautious to avoid injury of the recurrent laryngeal nerve and parathyroid, thus careful hemostasis during surgery is crucial for surgeons who perform thyroid surgery. Recently, there have been significant advances in vessel sealing systems for the occlusion of vessels during surgery as endoscopic surgery has been developed. UC and BES are now commonly used in thyroid surgery. However, only a few studies have compared the two surgical devices to determine which technique is superior in terms of operative time and complication rate. Thus, this single-blind prospective randomized trial is conducted to determine if there was a difference in operative time, complication rate, postoperative drainage volume, admission time, cost, and, furthermore, oncologic outcomes (RFS and OS) between the two surgical devices in surgery for thyroid cancer.

Safety and Efficacy Study of Ultrasonic Coagulation Device and Bipolar Energy Sealing System

Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated With the Harmonic ACE® Scalpel and LigaSure Precise™ Instrument During Conventional Thyroidectomy: A Single-blind Prospective Randomized Controlled Trial

Seoul St. Mary's Hospital

Division of Breast and Endocrine Surgery, Department of Surgery, The Catholic University of Korea College of Medicine

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

Cola

laparoscopic surgery in right colon cancer operations

open surgery in right colon cancer operations

Laurent Hannoun, MD, PhD

The primary goal of this study is to compare in the long-term costs of laparoscopic or open right colectomy in patients sustaining a colon cancer controling for the carcinologic equivalence of the two surgical strategies. The secondary goals to compare long-term mortality, morbidity as well as quality of life of the two groups.The present study is an prospective multicentric observational trial taking into account the usual surgical strategy of every centers

The aim of the present study is to compare in the long-term costs of laparoscopic and open right cancer colectomy as well as the mortality the morbidity and the quality of life of the operated patients.

The number of patients need to get a 54% power is 300. The average number of patients/surgical center is approximately 27 in 14 surgical centers.

The proposed undertaking of every patient is fully identical to that which is usually proposed by the surgical center in charge of the patient (i.d. 7 centers will perform laparoscopic procedures and 7 centers open procedure according to their usual practice).

A complete information leaflet will be given to the patients during the first consultation which will correspond to the enrollment day.

The preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center.

The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed e-questionnaire.

The follow-up encompass 5 postoperative consultations:1 month, 6 ,12 ,18 and 24 months.

On every consultation the patient will fill a very simple validated quality of life questionnaire (EORTC,QLQ.C30) an give back a weekly journal reporting the potentially arising medical and surgical events.

Globally the comparative analysis of the costs ,the mortality ,the morbidity, the quality of life ot the patients undergoing either a laparoscopic or a open right colectomy for cancer will be performed controling for the carcinologic equivalence of the two surgical strategies.

Laparoscopic Surgery Equivalent to Open Surgery in Right Colon Cancer Surgery?

Right Colon Cancer: Laparoscopic Surgery Versus Open Surgery, Costs, Mortality, Morbidity and Quality of Life

Assistance Publique - Hôpitaux de Paris

After complete right colon mobilization and ileocolic and right colic vessels ligation, the proximal transverse colon and the terminal ileum are transected and a side-to-side anastomosis is fashioned with a laparoscopic stapler.

After complete right colon mobilization and ileocolic and right colic vessels ligation, the terminal ileum, right colon, and proximal transverse colon are exteriorized for bowel division through a small midline skin incision in the upper abdomen. Then, a primary ileocolic side-to-side handsewn or mechanical anastomosis is fashioned extracorporeally.

After complete right colon mobilization and ileocolic and right colic vessels ligation, the proximal transverse colon and the terminal ileum are transected with a laparoscopic EndoGIA TM stapler (Covidien Medtronic). The antimesenteric side of the stapled ends of the transverse colon and terminal ileum are approximated by a stay suture tied intracorporeally and then held by the assistant. An antimesenteric enterotomy and an antimesenteric colotomy are made about 10 cm distal to the stapled ends of the transverse colon and terminal ileum, respectively. A side-to-side anastomosis is fashioned with a laparoscopic EndoGIA TM stapler (Covidien Medtronic). The enterotomies are then closed by two layers of reabsorbable sutures tied intracorporeally. The specimen is delivered through a small Pfannenstiel or a median incision. A big dressing covering all incisions will be applied, similar to that used for the EIA group.

Laparoscopic right colectomy with intracorporeal ileocolic anastomosis (IIA)

After complete right colon mobilization and ileocolic and right colic vessels ligation, the terminal ileum, right colon, and proximal transverse colon are exteriorized for bowel division through a small midline skin incision in the upper abdomen. A primary ileocolic side-to-side handsewn or mechanical (with GIA stapler - Covidien Medtronic) anastomosis is fashioned and the bowel returned to the abdominal cavity. After reinduction of pneumoperitoneum, the lack of twists of the ileocolic anastomosis is checked. A big dressing covering all incisions will be applied.

Laparoscopic right colectomy with extracorporeal ileocolic anastomosis (EIA)

Marco E Allaix, MD, PhD

Mario Morino, MD

Giuseppe Giraudo, MD, PhD

Alberto Arezzo, MD

Simone Arolfo, MD

Maurizio Degiuli, MD

Massimiliano Mistrangelo, MD, PhD

Roberto Passera, MD

Marco A Bonino, MD

During the last few years, the laparoscopic right colectomy with intracorporeal ileocolic anastomosis (IIA) has been proposed as an alternative to laparoscopic right colectomy with extracorporeal ileocolic anastomosis (EIA) for the treatment of right colon tumors. However, the level of evidence coming from the currently available literature is low, based on the results of a few small and heterogeneous retrospective non-randomized studies. A randomised controlled trial is warranted to challenge these two procedures. The aim of this randomized controlled trial is to assess the outcomes after IIA or EIA after laparoscopic right colectomy for right colon tumors.

While there are no differences in oncologic principles (no touch technique, proximal vessel ligation, lymphadenectomy) between laparoscopic right colectomy with IIA and EIA, potential advantages of IIA are: (1) no need for extensive mobilization of the transverse colon to reach the abdominal wall; (2) performing the anastomosis away from the abdominal wall may lead to reduced rates of superficial site infection; (3) a shorter incision for the specimen extraction may be associated with clinical benefits such as less pain and lower rates of superficial site infections; (4) laparoscopic visualization during the creation of the IIA may reduce unrecognized twisting of the terminal ileum mesentery, and (5) the ability to remove the specimen through any type of incision, with subsequent reduced risks of incisional hernias in case of Pfannenstiel incision when compared to midline or off-midline incisions.

Some retrospective and heterogeneous studies comparing perioperative outcomes after laparoscopic right colectomy with EIA and IIA have been published in the last decade, reporting controversial results. Furthermore, the results of recent metanalyses are challenged by the heterogeneity and the poor quality of the published studies. Lastly, no comprehensive economic evaluation of the two procedures have been performed yet.

Consecutive patients with right colon tumors are included in a randomized controlled trial. This is a single Institution prospective randomized controlled trial comparing the outcomes in patients undergoing laparoscopic right colectomy with IIA or EIA for right colon neoplasm. Eligible patients will be randomly assigned in a 1:1 ratio to undergo either laparoscopic IA or EA according to a list of randomization numbers with treatment assignments. This list will be computer generated. An Internet application will allow central randomization.

Cost analysis will be based on the following costs: surgical instruments (including re-usable trocars and disposable tools), operative room, routine postoperative surgical care, diagnosis and treatment of postoperative complications. Operative room costs include healthcare personnel, medications, and structure costs. To calculate the cost of each postoperative complication, the following items will be assessed: laboratory and microbiology analysis; medical, technical, and diagnostic services; surgical and therapeutic interventions; medications; prolonged hospital stay, and outpatient clinic follow-up. The mean length of hospital stay of uncomplicated patients will be the basis to calculate the prolonged hospital stay in each patient with complication. In patients who will develop multiple complications, resources used to treat each complication will be recorded separately.

A big dressing covering all incisions will be applied at the end of each operation in both arms.

Intracorporeal or Extracorporeal Anastomosis After Laparoscopic Right Colectomy.

Intracorporeal or Extracorporeal Ileocolic Anastomosis After Laparoscopic Right Colectomy.

evaluation of the number of lymph nodes in the specimen on pathology report

percentage of patients requiring narcotics after surgery

Cost analysis will be based on the following costs: surgical instruments (including re-usable trocars and disposable tools), operative room, routine postoperative surgical care, diagnosis and treatment of postoperative complications. Operative room costs included healthcare personnel, medications, and structure costs. To calculate the cost of each postoperative complication, the following items will be assessed: laboratory and microbiology analysis; medical, technical, and diagnostic services; surgical and therapeutic interventions; medications; prolonged hospital stay, and outpatient clinic follow-up. The mean length of hospital stay of uncomplicated patients will be the basis to calculate the prolonged hospital stay in each patient with complication. In patients who will develop multiple complications, resources used to treat each complication will be recorded separately.

the SF-12 questionnaire will assess quality of life

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Financial Toxicity and Patient-Reported Outcomes in GEP-NEN During Treatment	NCT05334290	Neuroendocrine ...		18 Years -	IRCCS San Raffaele
Evaluation of the Cost and Effectiveness Sunitinib Compared to Interferon-Alfa in Finland	NCT00980213	Neoplasms Renal Cell Carc...	sunitinib	18 Years - 85 Years	Tampere University Hospital
Financial Toxicity and Patient-Reported Outcomes in GEP-NEN During Treatment	NCT05334290	Neuroendocrine ...		18 Years -	IRCCS San Raffaele
Study Conducted Among Patients With CML	NCT05476562	Chronic Myeloid...	Tyrosine Kinase...	18 Years - 85 Years	Novartis
Safety and Efficacy Study of Ultrasonic Coagulation Device and Bipolar Energy Sealing System	NCT01565486	Thyroid Cancer	Ultrasonic coag... bipolar energy ...	20 Years - 80 Years	Seoul St. Mary's Hospital
Laparoscopic Surgery Equivalent to Open Surgery in Right Colon Cancer Surgery?	NCT01772407	Colon Cancer		18 Years - 80 Years	Assistance Publique - Hôpitaux de Paris
Study Conducted Among Patients With CML	NCT05476562	Chronic Myeloid...	Tyrosine Kinase...	18 Years - 85 Years	Novartis
Evaluation of the Cost and Effectiveness Sunitinib Compared to Interferon-Alfa in Finland	NCT00980213	Neoplasms Renal Cell Carc...	sunitinib	18 Years - 85 Years	Tampere University Hospital
Intracorporeal or Extracorporeal Anastomosis After Laparoscopic Right Colectomy.	NCT03045107	Colon Cancer Anastomosis	Laparoscopic ri... Laparoscopic ri...	18 Years -	University of Turin, Italy
Safety and Efficacy Study of Ultrasonic Coagulation Device and Bipolar Energy Sealing System	NCT01565486	Thyroid Cancer	Ultrasonic coag... bipolar energy ...	20 Years - 80 Years	Seoul St. Mary's Hospital

Spots Global Cancer Trial Database for costs

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

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