Infections

All Conditions

Neoplasms

Blood and Lymph Conditions

Symptoms and General Pathology

Immune System Diseases

Nervous System Diseases

Musculoskeletal Diseases

Rare Diseases

Leukemia

Communicable Diseases

Lymphoma

Leukemia, T-Cell

Virus Diseases

Bone Marrow Diseases

Paraparesis, Tropical Spastic

HTLV-I Infections

HTLV-II Infections

Muscle Spasticity

Paraparesis

Leukemia-Lymphoma, Adult T-Cell

Spinal Cord Diseases

Disease Attributes

Leukemia, Lymphoid

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Central Nervous System Diseases

Myelitis

Central Nervous System Infections

Retroviridae Infections

RNA Virus Infections

Neuroinflammatory Diseases

Syndrome

Immunologic Deficiency Syndromes

Lymphosarcoma

Human T-cell Leukemia Virus Type 1

HTLV-1 Associated Myelopathy/tropical Spastic Paraparesis

Leukemia, T-cell, Chronic

Human T-cell Leukemia Virus Type 2

Serum/plasma specimens which are HTLV I, HTLV II or HTLV I/II known positive (KP)

Serum/plasma specimens with symptoms or any of the following neurological disorders: Acute Disseminated Encephalitis, Amyotrophic Lateral Sclerosis, Autonomic Dysfunction, Conus Medularis Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Dermatomyositis, HAM-TSP, Meningitis, Mild Cognitive Impairment, Multiple Sclerosis, Polymyositis, Spastic Paraparesis, Sciatica

HTLV I/II Confirmation and Differentiation

MP Diagnostics HTLV Blot 2.4

Sara Dionne, PhD

This post-market study is intended to assess the performance of the HTLV Blot 2.4 in repository serum/plasma specimens with neurological disorders (n=100) or an HTLV known positive infection (n=50).

The HTLV Blot 2.4 Post-Market Clinical Study is an open-label, multi-center, single-blind clinical study of neurological disorders (n=100) and HTLV known-positive (KP) specimens (n=50). This study is being conducted to support additional labeling claims and to further assess the sensitivity and specificity of the HTLV Blot 2.4 in specimens with neurological disorders and HTLV known positive specimens.

Cohort A: 100 Neurological Disorder Specimens Cohort B: 50 HTLV Known Positive Specimens

Clinical Sites and the Reference Core-Lab will be masked of specimen disease state

MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

HTLV Blot 2.4 Post-Market Clinical Study of Neurological Disorders and HTLV Positive Specimens

All clinical study data will be compiled and shared with investigators following database lock.

MP Biomedicals Asia Pacific Pte. Ltd.

MP Biomedicals, LLC

Blood donor specimens that tested repeat reactive on the first FDA licensed HTLV screening assay and non-reactive on the second FDA licensed HTLV screening assay

Susan Stramer, Ph.D

The purpose of this study is to assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4 in blood specimens testing repeat reactive (RR) on the first FDA licensed screening assay (Abbott Prism) and non-reactive (NR) on the second FDA licensed screening assay (Avioq ELISA).

This is a prospective study designed to assess the safety and effectiveness of a dual algorithm testing for HTLV I/II in blood donors. The study hypothesis is that blood donors testing repeat reactive (RR) on the first FDA licensed HTLV screening assay and non-reactive (NR) on a second FDA licensed screening assay will be confirmed as indeterminate or negative on the MP Diagnostics HTLV Blot 2.4.

Dual Algorithm Post Market Clinical Study

Evaluation of the MP Diagnostics HTLV Blot 2.4

Individual patient data (IPD) was deidentified prior to sharing.

HTLV I/II confirmation of specimens testing RR on the first FDA licensed HTLV screening assay and non-reactive (NR) on a second FDA licensed HTLV screening assay.

Digestive System Diseases

Nutritional and Metabolic Diseases

Stomach Neoplasms

Malnutrition

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Nutrition Disorders

Stomach Cancer

Pharmaceutical Solutions

All Drugs and Chemicals

Parenteral Nutrition Solutions

Preparation of parenteral nutrition (PN): Among winuf(1820cc for central vein, 1,450cc for peripheral vein), smofkabaven(986cc for central vein, 1206cc for peripheral vein), and nutriplex(1875cc for central vein, 1,250cc for peripheral vein) Amount of PN: Total energy expenditure (TEE) of the patients will be calculated with Harris-Benedict Equation, activity factor, and stress factor. The amount of calorie from oral intake will be subtracted from TEE then the remainder will be provided through PN.

Route of PN Injection: PICC (percutaneously-inserted central catheter) will be secured for PN for the central vein. PN for the peripheral vein will be injected directly through peripheral superficial vein.

* Day0 : fasting(NPO) + crystalloid fluid
* POD#1 : Keep fasting, then start sips of water in the evening + crystalloid fluid
* POD#2 : Semifluid diet (SFD) + crystalloid fluid
* POD#3 : Semifluid diet (SFD) + PN
* POD#4-7: Soft blended diet (SBD) + PN

* Day0 : fasting(NPO) + crystalloid fluid
* POD#1 : Keep fasting, then start sips of water in the evening + crystalloid fluid
* POD#2 : Semifluid diet (SFD) + dextrose 5% water
* POD#3 : Semifluid diet (SFD) + dextrose 5% water
* POD#4-7: Soft blended diet (SBD)

* Day0 : fasting(NPO) + crystalloid fluid
* POD#1 : Keep fasting, then start sips of water in the evening + crystalloid fluid
* POD#2 : Semifluid diet (SFD) + crystalloid fluid
* POD#3 : Semifluid diet (SFD) + PN
* POD#4-7: Soft blended diet (SBD) + PN

Hyuk-Joon Lee, Professor

Sa-Hong Kim, Fellow

Hyuk-Joon Lee, MD, PhD

* If a patient undergoes gastrectomy, which is a kind of major abdominal operation, he/she loses more than 5% of his/her body weight in 2 months after surgery. This point is one of the criteria of 'risk of malnutrition' according to Nutrition Risk Screening (NRS 2002) and the patient who corresponds to this criterion needs nutritional support.
* According to Nutrition Risk Screening (NRS 2002), moderate malnutrition is defined as the state that the patient orally intakes 25\~50% of recommended requirements; severe malnutrition is less than 25%.
* Meanwhile, when oral nutrition support was provided to patients after gastric cancer surgery, the patients' average daily intake during the first three months was about a half of the recommended requirements.

  * Putting together the facts i) that the patient underwent major abdominal operation, ii) that the weight loss rate exceeded 5% for two months, iii) that the average daily intake of patients during the first three months was about half of the recommended amount, the patients are eligible to be classified as a group who require nutritional support according to NRS 2002.

Therefore, it is intended to verify the efficacy and safety of supplemental parenteral nutrition by comparing Arm A, who are provided oral intake with supplemental parenteral nutrition, Arm B, who are provided oral intake only after curative gastric cancer surgery.

With at least 5 days of supplemental parenteral nutrition, we expect minimized body weight loss, favorable blood test result, eligibility for chemotherapy compliance, increased quality of life (QoL), decreased infection rate, decreased hospital stay, and decreased mortality.

Supplemental Parenteral Nutrition During Postgastrectomy in Nutritionally at Risk Patient

The Effect of Postoperative Supplemental Parenteral Nutrition (SPN) in Gastric Cancer Patients Who Underwent Gastrectomy: A Multicenter Prospective Randomized Controlled Trial

Sharing the specific individual participant data sets is not mandatory.

Complete blood count : Hb (hemoglobin) : g/dl

Complete blood count : WBC (white blood cell) : cells/mm3

Complete blood count : TLC (total lymphocyte count) : cells/mm3

Blood chemistry : total cholesterol (mg/dl)

Blood chemistry : AST (aspartate aminotransferase) : IU/L

Blood chemistry : ALT (alanine aminotransferase) : IU/L

Blood chemistry : CRP (C-reactive protein) : mg/dl

ECOG(Eastern Cooperative Oncology Group) performance status: 0\~5 (higher scores mean a worse outcome) 0 : Fully active, able to carry on all pre-disease performance without restriction 5 : Death

ASA(American Society of Anaesthesiologists) score : 1\~6 (higher scores mean a worse outcome)

1 : A normal healthy patient 6 : A declared brain-dead patient whose organs are being removed for donor purposes

EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30) : EORTC QLQ-C30 Scoring Manual (Fayers et al., 2001).

EORTC QLQ-STO22 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach 22) : Clinical and psychometric validation of a questionnaire module, the EORTC QLQ-STO 22, to assess quality of life in patients with gastric cancer (J.M Blazeby el al. 2004).

SF-36 (36-Item Short Form Health Survey) : 0\~100 (higher scores mean a worse outcome)

Seoul National University Hospital

Professor

Blood donor specimens that tested non-reactive by previously licensed HTLV screening assay.

Blood donor specimens that tested repeat reactive by previously licensed HTLV screening assay, but are unconfirmed.

Blood donor specimens that tested repeat reactive with a licensed HTLV screening assay and have been confirmed through additional, unlicensed supplemental testing.

Supplemental testing algorithm performed by the CDPHL.

CDPHL Algorithm

The purpose of this study is:

1. To assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4.
2. To conduct a sensitivity analysis of the HTLV Blot 2.4 using a known positive population.

This is a retrospective study designed to assess the validity and reproducibility of the MP Diagnostics IVD device, the HTLV Blot 2.4 (MP Blot), in various populations. The study will be conducted at three geographical distinct locations.

The validity of the MP Blot will be assessed by calculating the following:

1. Percent negative agreement with CDPHL Algorithm on 200 EIA negative specimens
2. Percent positive agreement with CDPHL Algorithm on 200 EIA repeat reactive specimens

The sensitivity of the MP Blot will be evaluated by testing 200 known positive specimens. The study will be performed using three product lots at three clinical sites.

The reproducibility of the MP Blot will be assessed by testing two replicates of a three member panel at three clinical testing sites with each of three lots of product over multiple days by three operators.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study	NCT03226119	HTLV-I Infectio... HTLV-II Infecti... Human T-lymphot... Human T-lymphot... HTLV I Associat... HTLV I Associat...	MP Diagnostics ...	18 Years -	MP Biomedicals, LLC
Dual Algorithm Post Market Clinical Study	NCT03146013	HTLV-I Infectio... HTLV-II Infecti... Human T-lymphot... Human T-lymphot... HTLV I Associat... HTLV I Associat...	MP Diagnostics ...	18 Years -	MP Biomedicals, LLC
Supplemental Parenteral Nutrition During Postgastrectomy in Nutritionally at Risk Patient	NCT04607057	Gastric Cancer Gastrectomy Malnutrition	Parenteral Nutr...	18 Years -	Seoul National University Hospital
Evaluation of the MP Diagnostics HTLV Blot 2.4	NCT01467024	HTLV-I Infectio... HTLV-II Infecti... Human T-lymphot... Human T-lymphot... HTLV I Associat... HTLV I Associat...	CDPHL Algorithm	18 Years -	MP Biomedicals, LLC

Spots Global Cancer Trial Database for supplemental

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