Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Patients with pulmonary nodules (diameter ≤3cm) plan to use biopsy or surgery or treatment to diagnosis benign and malignant.

Up to 15 ml of peripheral blood will be collected from each subject, and the blood specimen will be processed to isolate mature red blood cells and extract the DNA and RNA from RBCs. DNA and RNA methylation will be tested by next-generation sequencing (NGS).

Methylation tests of nucleic acids extracted from mature red blood cells (RBCs)

Zichen Jiao, MD

Tao Wang, MD

This study plan to enroll 852 patients with pulmonary nodules smaller than 3 cm in diameter, whose DNA and RNA will be extracted from mature red blood cells isolated from peripheral blood. The DNA 5-methylcytosine(5-mC) and RNA 2'-O-methylation information will be acquired by NGS and Nm Judge Universally sequencing (NJU-Seq), which will be used to establish models to distinguish patients with benign and malignant nodule in the training group and further evaluated in the validation group. The pathological results will be acquired after surgery or biopsy as standard in the study.

This is a prospective, multi-center, observational, cohort study and seeks to enroll 852 participants with pulmonary nodules smaller than 3 cm in diameter from 4 hospitals in China.

Each participant pulmonary nodule is ≤30mm as assessed by CT scanning, nodule is suspected to be malignant, and plan to use biopsy or surgery for diagnosis or treatment within 60 days.Their blood samples, CT scan data, and clinical data will be collected at each visit and tissues will be collected when participants who receive pneumonectomy or percutaneous lung biopsy.

Each subject will analysis DNA and RNA methylation in nucleic acids extracted from mature red blood cells isolated from peripheral blood by next-generation sequencing (NGS) . A proprietary algorithm will be used to identify the modification sites and pattern for differentiating the benign and malignant pulmonary nodules. Sensitivity and specificity of the different methylation panels will be to evaluated.

The Red Blood Cells Based Blood Test for Lung Cancer EARLY Detection

The Training and Validation Study: Development of a Red Blood Cells Based Blood Test for Early Detection of Lung Cancer

Peking Union Medical College Hospital

Shanghai Chest Hospital

Guangzhou Panyu Central Hospital

My-BioMed Technology （Guangzhou） Co., Ltd.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Carcinoma

Multiple Myeloma

Neoplasms, Plasma Cell

Prostatic Neoplasms

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Lymphoma

Anemia

Carcinoma, Small Cell

Esophageal Neoplasms

Small Cell Lung Carcinoma

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Neoplasms, Glandular and Epithelial

Carcinoma, Bronchogenic

Bronchial Neoplasms

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Lymphosarcoma

Small Cell Lung Cancer

Hematinics

All Drugs and Chemicals

Epoetin Alfa

epoetin alfa

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with cancer receiving chemotherapy, and to investigate possible quality-of-life benefits associated with the use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, in part because of the fatigue associated with anemia. Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level may improve quality of life and help patients live longer. This study is a 12-week, double-blind, placebo-controlled multicenter study to compare the ability of epoetin alfa and placebo in reducing or preventing anemia and transfusions, and to investigate quality-of-life benefits associated with the use of epoetin alfa in patients receiving chemotherapy for selected cancers. During the double-blind period there will be two groups of patients: one group receiving epoetin injections under the skin 3 times per week (starting at 150 units per kilogram, adjusted if needed to a maximum of 300 units per kilogram) and other group receiving injections under the skin of a placebo of matching appearance and volume. If hemoglobin rises above 140 grams per liter (women) or 150 grams per liter (men), the dose will be adjusted to keep hemoglobin within a target range. A 12-week open-label extension of the study will be available to all patients completing the 12-week comparison period. The primary measure of effectiveness is determined by the proportion of patients with no transfusions after the first month. Additional measures of effectiveness include: the proportion of responders, the change of hemoglobin unrelated to transfusion, cumulative transfusion rate and proportion of patients transfused during the double-blind phase (excluding the first month), as well as the mean change over the study period in scores for energy, activity and overall quality of life. The results will be analyzed separately for non-platinum-containing chemotherapy and for different tumor types. Safety evaluations include assessments of the incidence and severity of adverse events, clinical laboratory tests, vital sign measurements, and physical examinations. The hypothesis of the study is that epoetin alfa is superior to placebo in improving anemia, reducing the number of transfusions, and improving quality of life. Epoetin alfa 150 units (U) per kilogram (kg) or placebo, injected under the skin 3 times weekly for 4 weeks; then either continued at 150 U/kg or adjusted to 300 U/kg according to hemoglobin levels for the remaining 8 weeks. Open-label (12 weeks): dose to maintain target hemoglobin range.

The Effect of Epoetin Alfa on the Anemia of Patients With Selected Cancers Receiving Chemotherapy

A Placebo-Controlled Study on the Effect of Epoetin Alfa in Patients With Malignancy Receiving Chemotherapy

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Wounds and Injuries

Symptoms and General Pathology

Burns

Hemorrhage

Hypoxia

Hematologic Neoplasms

Subjects requiring chronic transfusions with red blood cells for treatment of a hematologic malignancy will receive 1 transfusion with 2 units of hypoxic red blood cells manufactured with the Hemanext ONE device. The subjects will be monitored for all adverse events from Informed Consent through Day 28 or the subsequent standard of care transfusion, whichever occurs first.

Subjects requiring transfusion with red blood cells during the excision procedure after an acute burn will receive 2 units of hypoxic red blood cells manufactured with the Hemanext ONE device. As the excision treatments require transfusion of more than 2 units of red blood cells, the first 2 units transfused during the procedure will be hypoxic red blood cells. The subjects will be monitored for all adverse events through Day 28.

Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced

Hypoxic Red Blood Cells

Kimberly Dorsch

Stian Almeland, MD

Hakon Reikvam, MD

The overall objective of this study is to collect preliminary safety data on the transfusion of hypoxic RBCs, manufactured with the Hemanext ONE device, in patients with burns and patients with hematological malignancies. The Hemanext ONE device received CE mark in April 2021.

The primary objective is to assess hypoxic RBCs safety and tolerance assessment up to 24 hours following the transfusion initiation and overall up to 7 days (+/- 1 day) after the transfusion episode (single transfusion course).

Secondary objectives include the following.

1. Assessment of pre and post transfusion hemoglobin levels
2. Assessment of hemoglobin level before the following transfusion, if applicable
3. Assessment of AEs occurrence:

   i. Up to 7 days (+/- 1 day) post transfusion, in comparison with historical control (including but not limited to infection, deep vein thrombosis, acute respiratory distress syndrome, transfusion-related acute lung injury, transfusion associated circulatory overload, anaphylactic shock, acute hemolytic transfusion reaction).

   ii. Up to the subsequent transfusion episode or up to 28 days (+/- 1 day) after the initial transfusion, whichever comes first.

   iii. From enrollment, up to their subsequent transfusion or 28 days (+/- 1 day) post transfusion, whichever comes first, through the assessment of patient's diary.
4. Assessment of the vital signs during and up to 15 minutes after the transfusion.

Hypoxic Red Blood Cells for Burns and Hematological Malignancies at Haukeland University Hospital

A Single Center, Pilot Clinical Investigation of Surgical Bleeding in Burn Patients, and Chronically Transfused Patients With Haematologic Malignancies, Who Are Transfused With Hypoxic Red Blood Cells Manufactured With Hemanext ONE System

The type and the grade of each adverse event will be categorized according to:

* Association for the Advancement of Blood and Biotherapies (AABB) technical manual, 20th edition (2020)
* Biomedical Excellence for Safer Transfusion (BEST) Collaborative review - Lancet 2016; 388: 2825-36
* Local AEs database (for reference)
* ISO 14155-2020 definitions

The difference in measured hemoglobin (grams/dL) between pre-transfusion and up to 30 minutes post-transfusion.

The hemoglobin increment from each transfusion will be determined by calculating the difference between the subject's post-transfusion and pre-transfusion hemoglobin (g/dL). It will then be corrected for estimated subject blood volume and the amount of Hb transfused.

The following equation used for the hemoglobin increment calculation:

HgB Increment = (Subject's HgB level post-transfusion - Subject's HgB pre-transfusion)/ (total HgB transfused x Subject's BloodVolume)

Equations for calculating the hemoglobin increment may be found in the following publication: Wendelbo Ø, Opheim EN, Hervig T, Felli Lunde TH, Bruserud Ø, Mollnes TE, Reikvam H. Cytokine profiling and post-transfusion haemoglobin increment in patients with haematological diseases. Vox Sang. 2018 Oct;113(7):657-668. doi: 10.1111/vox.12703. Epub 2018 Aug 29. PMID: 30159896.

The difference in measured hemoglobin (grams/dL) between the pre-transfusion hemoglobin level for the study transfusion and the pre-transfusion hemoglobin level for the next scheduled transfusion.

Review of blood pressure (systolic/diastolic; mmHg) throughout the study transfusion.

Review of respiratory rate (breaths per minute) throughout the study transfusion.

Review of amount of oxygen in the body (% S02 level) measured with a pulse oximeter throughout the study transfusion.

Review of heart rate (beats per minute) throughout the study transfusion.

Hemanext

Behaviors and Mental Disorders

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphatic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Quality of Life

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

The purpose of this study is to evaluate the effect of treatment with epoetin alfa versus placebo on the percentage of red blood cells in anemic patients with chronic lymphocytic (white blood cell) leukemia and its effect on the patients' quality-of-life. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, in part because of the fatigue associated with anemia. Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level may improve the quality of life and help patients live longer. This is a 12-week, double-blind, placebo-controlled, multicenter study to determine the effect of treatment with epoetin alfa on the percentage of red blood cells in anemic patients with chronic white blood cell leukemia. At the start of the study, patients were either receiving no chemotherapy, single-agent chemotherapy, and/or were on prednisone (steroid) treatment. Patients will be randomly assigned 2:1 to receive either epoetin alfa or placebo. Patients receiving epoetin alfa will receive subcutaneous (under the skin) epoetin alfa injections 3 times per week and patients on placebo will receive an equal volume of matching placebo, injected subcutaneously 3 times per week. Based on patients' rate of increase in red blood cell percentage, the original dose of 150 units per kilogram 3 times per week may be raised gradually to 300 units per kilogram 3 times per week, to reach a target red blood cell percentage of 38% to 40%. Patients achieving the target red blood cell percentage will be eligible for a 12-week open-label extension of the study, which will focus on safety findings. Effectiveness will be determined by the proportion of patients who reach the target red blood cell percentage of 38% to 40% by the end of the study, the number of transfusions required, the proportion of patients achieving a red blood cell percentage of 38% to 40% at any time during the study, and changes in quality of life parameters. Safety evaluations, including the incidence of adverse events, laboratory tests, and vital signs, will be performed throughout the study. The hypothesis of the study is that epoetin alfa will be superior to placebo in increasing the percentage of red blood cells to the target level, reducing the number of transfusions required, and improving the quality of life. Epoetin alfa 150 units per kilogram 3 times weekly subcutaneously for 12 weeks. Individualized dose increases of 50 mg/week depend on red blood cell response, up to a maximum 300 units per kilogram 3 times per week to obtain the target level of 38% to 40% red blood cells.

Epoetin Alfa for the Treatment of Anemia Resulting From Chronic Lymphocytic Leukemia

The Effect of Subcutaneous r-HuEPO in Patients With Chronic Lymphocytic Leukemia

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Red Blood Cells Based Blood Test for Lung Cancer EARLY Detection	NCT05380999	Lung Cancer Red Blood Cells Methylation	Methylation tes...	18 Years -	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The Effect of Epoetin Alfa on the Anemia of Patients With Selected Cancers Receiving Chemotherapy	NCT00270166	Anemia Multiple Myelom... Lymphoma Breast Cancer Ovarian Cancer Carcinoma, Smal... Esophagus Cance... Prostate Cancer Neoplasm	epoetin alfa	18 Years - 80 Years	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Hypoxic Red Blood Cells for Burns and Hematological Malignancies at Haukeland University Hospital	NCT05549232	Hematologic Neo... Burns	Hypoxic Red Blo...	18 Years -	Hemanext
Epoetin Alfa for the Treatment of Anemia Resulting From Chronic Lymphocytic Leukemia	NCT00270049	Anemia Leukemia, Lymph... Leukemia, Lymph... Cancer Neoplasms Quality of Life	epoetin alfa	18 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Epoetin Alfa for the Treatment of Anemia Resulting From Chronic Lymphocytic Leukemia	NCT00270049	Anemia Leukemia, Lymph... Leukemia, Lymph... Cancer Neoplasms Quality of Life	epoetin alfa	18 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Spots Global Cancer Trial Database for red blood cells