Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

All Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Nervous System Diseases

Rare Diseases

Nasopharyngeal Carcinoma

Recurrence

Carcinoma

Small Cell Lung Carcinoma

Breast Neoplasms

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Prostatic Neoplasms

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Lung Neoplasms

Papilloma

Carcinoma, Basal Cell

Breast Neoplasms, Male

Granuloma

Carcinoma, Adenoid Cystic

Laryngeal Diseases

Esthesioneuroblastoma, Olfactory

Carcinoma, Acinar Cell

Carcinoma, Verrucous

Papilloma, Inverted

Carcinoma, Mucoepidermoid

Mucoepidermoid Tumor

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Small Cell Lung Cancer

Breast Cancer, Male

Laryngeal Cancer

Hypopharyngeal Cancer

Adenoid Cystic Carcinoma

Olfactory Neuroblastoma

Acinic Cell Carcinoma

Camurati-Engelmann Disease

Mucoepidermoid Carcinoma

Metastatic Squamous Neck Cancer With Occult Primary

Midline Lethal Granuloma

All Drugs and Chemicals

Herbal and Botanical

Mitogens

Cola

Patients with head and neck cancer, and lung, breast, colorectal, and prostate cancers who are to undergo radiation therapy

Venipuncture for blood samples. Samples will be tested for TGF-beta.

venipuncture

Radiation treatments vary according to type of cancer and by patient per doctors' recommendation

radiation therapy

A. Bapsi Chakravarthy, MD

RATIONALE: Measuring levels of transforming growth factor-beta (TGF-beta) in the blood of patients with epithelial cancers (head and neck, lung, breast, colorectal, and prostate) may help doctors predict how patients will respond to treatment with radiation therapy.

PURPOSE: This research study is measuring levels of TGF-beta in patients with epithelial cancers who are undergoing radiation therapy.

OBJECTIVES:

* To determine whether there is a dose-dependent increase in TGF-beta following radiotherapy in patients with epithelial cancers.

OUTLINE: Patients undergo blood sample collection prior to treatment, 24-72 hours after the first fraction of radiotherapy, and at the end of radiotherapy. Patients will also be asked for a weekly blood sample, but this is optional. Samples are analyzed to compare pre- and post-treatment TGF-beta levels.

Growth Factor Levels in the Blood of Patients Undergoing Radiation Therapy for Epithelial Cancer

A Pilot Study of TGF-beta as a Potential Target for Prevention of Radiation-Induced Injury

TGF-beta is a protein that can be detected in the blood.

National Cancer Institute (NCI)

Vanderbilt-Ingram Cancer Center

Associate Professor

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Before the start of sample collection questionnaire A on paper will be filled in by all study subjects. The order of sample collection will be: automated capillary sampling, lancet capillary sampling and venipuncture. Herein automated and lancet capillary sampling will be performed by the study subjects themselves whereas the venipuncture will be performed by the study personnel. After all sampling has been completed, the subject is asked to complete questionnaire B which will evaluate pain, burden, ease of use and preference.

For subjects in arm A and C this entails the end of the study

The subjects of arm B are requested to perform automated capillary and lancet capillary sampling at home following their next two outpatient visits. During these outpatient visits, a reference value blood CEA measurement will be obtained using venipuncture by the personnel of the clinical laboratory of Erasmus MC. The required materials will be sent to the home address of the patient. Sampling will be performed at home and by the subjects themselves. Subjects will have access to the tutorial videos for automated and lancet capillary sampling.

The TAP-II device will be compared to lancet capillary sampling and the venipuncture

TAP-II

The lancet capillary sampling will be compared to TAP device and the venipuncture

Lancet capillary sampling

The venipuncture will be compared to TAP device and the lancet capillary sampling

Venipuncture

Kelly R Voigt, MD

Lissa Wullaert, MD

Dirk J. Grünhagen, MD, PhD

The goal of this study is to determine the feasibility of CEA assessments at home using (automated) capillary sampling in patients in the follow-up after treatment for colorectal cancer.

The main questions it aims to answer are:

* To determine the success rate of capillary sampling at home by the patient
* To assess reliability and satisfaction of (automated) capillary CEA measurements Participants will be asked to perform automated capillary sampling and lancet capillary sampling at home twice after regular check-up visits in the hospital, with an interval of 3-6 months in between. During this hospital visit, a CEA measurement in blood sampled by venipuncture will be performed to act as a reference for the CEA measurements in (automated) capillary blood to be sampled at home.

Reliability of CEA measurements will be assessed for automated capillary and lancet capillary sampling compared to venipuncture.

Satisfaction in terms of patient reported outcomes (pain, burden, ease of use, and preference) will be evaluated.

The follow-up of patients after colorectal cancer surgery mainly consists of blood CEA assessments. These blood assessments could be done at home and could be beneficial in terms of patients' well-being and societal cost-effectiveness. Capillary blood sampling can be an alternative to venipuncture in home based or decentralized surveillance as it can be performed by the patient themselves. Before home based capillary sampling can be implemented, feasibility, reliability, and satisfaction for serum CEA measurements has to be determined.

Feasibility, Reliability, and Satisfaction of CEA Using Home Based (Automated) Capillary Blood Sampling

Feasibility, Reliability, and Satisfaction of Carcinoembryonic Antigen Measurements Using Home Based (Automated) CApillary Blood SAmpling; the Prospective CASA-I Study

Home based (automated) capillary sampling will be considered feasible if a success rate of 85% or greater has been reached. Herein a successful (automated) capillary sampling at home is defined as a sampling of blood by the patient that reached the clinical laboratory of the hospital via post and in which a CEA level could be determined reliably. Both capillary sampling methods will be analysed and compared to venepuncture separately.

Reliability will be assessed by a Bland-Altman analysis to determine mean bias and the 95% limits of agreement of measurements from (automated) capillary samples compared to venipuncture samples. These will be compared to predefined clinically relevant cut-off values for the mean bias and the limits of agreement. A mean bias of greater or equal to +/- 5% and or 95% limits of agreement equal to or greater than +/- 10% will be considered clinically relevant and thereby unreliable. These cut-off values are defined based on previously found 95% limits of agreement of the automated capillary sampling device and the precision of the Cobas 8000 analyzer which will be used to perform the CEA analyses.

All study subjects will be asked to complete the questionnaire to evaluate pain, burden, ease of use and preference. Herein they are asked to provide their perceived level of pain separately for automated capillary sampling, lancet capillary sampling and venipuncture. A visual analogue scale ranging from 0 to 10 will be used to measure perceived level of pain. Pain measurements will be compared across all three sampling methods in the entire cohort of 100 subjects using repeated measures ANOVA. An α \< 0.05 will be considered statistically significant.

the sample processing time from entering the clinical laboratory until a successful measurement is obtained will be compared across all sampling methods using analysis of variance (ANOVA). An α \< 0.05 will be considered statistically significant.

Erasmus Medical Center

Principal Investigator

Immune System Diseases

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Hematologic Neoplasms

Immunologic Deficiency Syndromes

Mucopolysaccharidoses

Mucopolysaccharidosis I

Neuroblastoma

Severe Combined Immunodeficiency

Syndrome

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Metabolism, Inborn Errors

Carbohydrate Metabolism, Inborn Errors

Genetic Diseases, Inborn

Lysosomal Storage Diseases

Mucinoses

Connective Tissue Diseases

Metabolic Diseases

Primary Immunodeficiency Diseases

Infant, Newborn, Diseases

DNA Repair-Deficiency Disorders

Hematologic Diseases

Mucopolysaccharidosis

Mucopolysaccharidosis Type I

Neuroepithelioma

Vaccines

Immunologic Factors

Stephen Gottschalk, MD

This protocol (GENEFU) provides a mechanism for the 15-year followup period that the FDA requires for all participants in gene transfer protocols and assures that adequate followup can be maintained for a wide variety of participants on different individual gene therapy protocols at St. Jude Children's Research Hospital.

GENEFU serves as an umbrella protocol for long-term follow-up (LTFU) for recipients of gene therapy/gene marked (GT/GM) products at St. Jude Children's Research Hospital. The FDA has recommended methods to assess the risk of delayed adverse events after GT/GM and has provided specific requirements regarding the duration and design of LTFU observations. This protocol is intended to provide LTFU in accordance with the FDA guidelines for those who received a GT/GM product as part of a St. Jude-sponsored clinical trial or compassionate use treatment plan. The protocol calls for a physical examination or general health evaluation and collection of required blood samples annually for up to 15 years after the last receipt of a GT/GM product.

Goals will be to obtain clinical histories in order to detect late clinical outcomes suggestive of retroviral or lentiviral disease, including but not limited to cancer/second malignancies, neurologic disorders, autoimmune disorders, and hematologic disorders. Blood samples will be archived and tested when clinically or scientifically indicated, as in the event of development of a second malignancy. This prospective cohort study will utilize descriptive statistics in the analysis of long-term late effects outcomes. It offers a uniform approach to long-term safety monitoring in research participants who have received a gene-transduced product as part of St. Jude-sponsored GT or GM protocols and compassionate use treatment plans.

Secondary objectives include the following: to obtain and archive blood samples to 1) detect frequency of vector marking in peripheral blood mononuclear cells when clinically or scientifically indicated, such as in the event of participant development of second malignancy, autoimmune disease, hematologic abnormality, or neurologic event, and; 2) To obtain and archive blood samples to detect and characterize clonal proliferation events occurring in gene transfer trials when clinically or scientifically indicated.

Long Term Follow Up Of Patients Who Have Received Gene Therapy Or Gene Marked Products

Long Term Follow Up Of Patients Who Have Received Gene Therapy Or Gene Marked Products at St. Jude Children's Research Hospital

Obtain histories for detection of significant delayed medical events including hematologic, malignant, autoimmune, and neurologic events in research participants who have received an integrating vector-based gene therapy/gene marked product at St. Jude Children's Research Hospital (SJCRH).

St. Jude Children's Research Hospital

Precancerous Conditions

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

Lidocaine

The prospective SCC-PML cohort is envisioned to provide a well-matched group of high-risk subjects that will provide clinically comparable subjects with lesional sites representing progressive and non-progressive disease.

Bronchoscopy: Your nose, throat, vocal cords and windpipe are sprayed with Lidocaine (numbing medicine) to help keep you from coughing and to numb your airways. A tube with either a white light or the fluorescent light (bronchoscopy) is put down through your nose or mouth into your throat. Your nose, throat, vocal cords and lungs will be checked for any unusual areas while the tube goes down. You might have medicine sprayed into your mouth. You may be given a shot into your vein or muscle to help you be more comfortable.

Endobronchial Biopsy: Very tiny pieces of lung tissue (about the size of the head of a pin) will be taken from the lining of your lungs using forceps and a small brush. These tissues will be taken to a laboratory and tested.

Bronchoscopies

Subjects will be asked to perform the early morning spontaneous cough technique over a six-day period to provide for pre-screening evaluations. If moderate atypia is detected in a pre-screening specimen, additional sputum samples will be collected prior to each subsequent bronchoscopy. If this cannot be performed prior to bronchoscopy with adequate results, the sputum collection may be done after bronchoscopy. The sputum will be collected in containers containing Saccomanno's fixative.

Sputum Sample

Thirty milliliters of blood will be withdrawn from each subject, and the blood will be sent to the biorepository for analysis and storage.

Brandi Kubala

Dakota Hitchcock, BA

Michele Baloneque-Siqueira, BA

Robert Keith, MD

This protocol pertains specifically to the prospective lung squamous cell carcinoma pre-malignant lesion (PML) cohort that will form a primary study group for the Lung Pre-Cancer Atlas.

Via pre-screening, subjects at high risk for the development of lung squamous cell carcinoma (SCC) will be identified and enrolled to undergo serial bronchoscopies at 12 month intervals over a 2-3 year period. A variety of specimen types will be collected to support analyses of the genomic and microenvironmental features of these PMLs.

The Lung PCA: A Multi-Dimensional Atlas of Pulmonary Premalignancy

Prospective data collection of histologic specimens for the purposes of reducing lung cancer mortalities.

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

University of Colorado, Denver

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

Aflibercept

Endothelial Growth Factors

Angiogenesis Inhibitors

Growth Inhibitors

VEGF Trap

Bone marrow biopsy

bone marrow aspiration

For test of free VEGF Trap compared to bound VEGF Trap and for routine clinical testing during treatment

Stephen Strickland, MD

RATIONALE: Aflibercept may stop the growth of cancer cells by blocking blood flow to the cancer.

PURPOSE: This phase II trial is studying how well aflibercept works in treating patients with advanced refractory, relapsed, or untreated acute myeloid leukemia.

OBJECTIVES:

Primary

* To determine the response rate to aflibercept as a single agent in adult patients with advanced refractory, relapsed, or untreated acute myeloid leukemia (AML).
* To determine the 3-month progression-free survival following treatment with at least 4 courses of aflibercept in these patients.

Secondary

* To determine if there is any correlation between pre-treatment expression of VEGFR1 or VEGFR2 by marrow myeloblasts and disease response to aflibercept.
* To determine if bone marrow microvessel density (MVD) pre-treatment correlates with disease response to aflibercept, and if any decrease in MVD following treatment correlates with changes in bone marrow blast percentage (disease response).
* To assess changes in circulating endothelial cells (CEC) and circulating endothelial progenitor cells (EPC) as pharmacodynamic markers of aflibercept activity and possible correlates of disease response to aflibercept.
* To measure blood levels of free VEGF versus VEGF bound by aflibercept post-treatment to determine if the chosen dose of aflibercept is sufficient to bind all detectable soluble VEGF in these patients.
* To characterize the population pharmacokinetics of aflibercept with its associated interpatient variability and to explore for demographic and clinical covariates.
* To derive individual estimates of the duration over which VEGF-saturating aflibercept concentrations were systematically present and to examine their distribution across the population.
* To explore the potential relationship between the systemic-free and bound aflibercept levels and safety and efficacy data.

OUTLINE: This is a multicenter study.

Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow and blood sample collection periodically for pharmacokinetic/pharmacodynamic studies. Samples are analyzed for peak plasma-free aflibercept levels after the first infusion, trough plasma-free and bound aflibercept levels prior to each subsequent infusion and 60 days after the last infusion, and anti-aflibercept antibody via ELISA methods; circulating endothelial cells (CEC's) via ELISA and flow cytometry to determine if there is correlation between changes in circulating endothelial cells and changes in bone marrow blast percentage (i.e., disease response); myeloblast expression of VEGFR-1 and VRGFR-2 via immunohistochemistry (IHC); endothelial progenitor cells colony forming units (EPC-CFU's) to determine via in situ staining if changes in circulating endothelial progenitors following treatment with aflibercept correlates with disease response, and if there is a subpopulation of patients identified by pre-treatment circulating EPC-CFU's that may benefit from aflibercept; and bone marrow microvessel density (MVD) determination via immunohistochemistry.

After completion of study treatment, patients are followed for 60 days.

A Multi-Center Phase 2 Study of VEGF Trap as a Single Agent in Acute Myeloid Leukemia

A Multi-Center Phase 2 Study of Vascular Endothelial Growth Factor (VEGF) Trap as a Single Agent in Acute Myeloid Leukemia

As determined by the International Working Group: Complete response: bone marrow blast(BMB) percentage (%) \<=5% of nucleated cells and no detectable extramedullary disease; Partial response: BMB \>5% but decreased by at least 50% pre-treatment (pre-tx) value OR extramedullary disease still present; Stable disease: BMB \>5% and decreased or increased by \<50% of pre-tx value and no new extramedullary disease; Progressive disease: BMB \>=20% and an increase of at least 50% of pre-tx value and/or appearance of at least 50% in circulating blasts

Density of microscopically small blood vessels in bone marrow biopsies

Blood levels of free VEGF Trap compared to bound VEGF trap to determine if the chosen level of VEGF Trap is sufficient to bind all detectable soluble VEGF in this group of patients

Patients who undergo a minimum of 4 cycles of treatment and who have either a complete or partial response to treatment or who have stable disease and who are free of progressive disease at 12 weeks

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Growth Factor Levels in the Blood of Patients Undergoing Radiation Therapy for Epithelial Cancer	NCT00897793	Breast Cancer Colorectal Canc... Head and Neck C... Lung Cancer Prostate Cancer	venipuncture radiation thera...	18 Years -	Vanderbilt-Ingram Cancer Center
Feasibility, Reliability, and Satisfaction of CEA Using Home Based (Automated) Capillary Blood Sampling	NCT05646030	Colorectal Canc...	TAP-II Lancet capillar... Venipuncture	21 Years -	Erasmus Medical Center
Long Term Follow Up Of Patients Who Have Received Gene Therapy Or Gene Marked Products	NCT00695279	Severe Combined... Malignancy, Hem... Neuroblastoma Neoplasm Mucopolysacchar...	Venipuncture	-	St. Jude Children's Research Hospital
The Lung PCA: A Multi-Dimensional Atlas of Pulmonary Premalignancy	NCT03881098	Lung Cancer	Bronchoscopies Sputum Sample Venipuncture	18 Years -	University of Colorado, Denver
A Multi-Center Phase 2 Study of VEGF Trap as a Single Agent in Acute Myeloid Leukemia	NCT00601991	Leukemia	VEGF Trap Bone marrow bio... bone marrow asp... Venipuncture	18 Years -	Vanderbilt-Ingram Cancer Center
Angioedema Biomarker Research Study	NCT06210698	Angioedema Angioedemas, He... Urticaria Mastocytosis ACE Inhibitor-I... C1 Inhibitor De... Systemic Mastoc... Indolent System...	Venipuncture	12 Years - 75 Years	Foundation For Rare Disease Research

Spots Global Cancer Trial Database for venipuncture

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