Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients will not receive a patient-directed intervention.

Patients will receive a tailored interactive PC-based intervention at a freestanding kiosk.

PC-based tailored intervention

Patients will receive generic printed educational materials about CRCS in the PEC when they arrive at the Main Campus for their appointment.

Printed educational materials

Sally W Vernon, PhD

The primary goal of this research project is to conduct a 5-year prospective randomized trial of a theory-based intervention to increase patient completion of colorectal cancer screening (CRCS) among patients ages 50 to 64 years old.

Specific Aim 1: Identify behavioral, social, and environmental factors associated with CRCS in male and female patients ages 50 to 64 years old in a primary care practice in Houston, Texas.

1.1. Update literature reviews of CRCS adherence. 1.2. Conduct secondary analysis of relevant data from other projects. 1.3. Conduct focus groups with primary care patients to determine their knowledge, attitudes, and beliefs about CRCS and to gather data to use for development of the educational intervention.

Specific Aim 2: Develop a personal computer (PC)-based tailored interactive intervention based on the transtheoretical (stages of change) model to increase CRCS in accordance with American Cancer Society (ACS) CRCS guidelines.

Specific Aim 3: Evaluate the effectiveness of the PC-based tailored interactive intervention for increasing CRCS through a randomized controlled trial.

Specific Aim 4: Analyze the relationship between a number of predictor variables and CRCS completion in order to develop a more complete conceptual framework for understanding screening adherence.

Specific Aim 5: Conduct a cost-effectiveness analysis of the PC-based tailored interactive intervention for increasing CRCS in a primary care setting.

Tailored Interactive Intervention to Increase CRCS

6, 12, and 24 months post intervention, medical charts were reviewed to validate self-reported CRCS behavior.

Survey data were collected at 6,12,and 24 months.

National Cancer Institute (NCI)

The University of Texas Health Science Center, Houston

Professor

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Pancreatitis

Pancreatic Diseases

Endocrine Gland Neoplasms

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Patients undergoing any type of pancreatic surgery.

Open, laparoscopic or robotic surgery of the pancreas

Pancreatic surgery

Guiseppe K Fusai, MD, MS

Dimitri A Raptis, MD, MSc, PhD

Cristina Ferrone, MD

"Snapshot" study worldwide over 3 months in 2021. Provide a verified record of true morbidity and mortality. Identify modifiable predicting factors of outcome. Obtain PubMed citable co-authorship,

The PancreasGroup.org team is conducting a "snapshot" clinical study investigating the outcomes of pancreatic surgery worldwide. This "collaborative" model for snapshot clinical studies is a well-established approach for assessing current practice in a short period of time.

There will be 3 months of prospective enrolment and 3 months follow up within a 12-month frame. The study will provide highly valuable data on outcomes after pancreatic surgery.

The investigators are aiming at providing a verified record of true morbidity and mortality in consecutive unselected patients. This way the investigators will help identify relevant, modifiable predicting factors for outcome after pancreatic surgery.

International Pancreatic Surgery Outcomes Study - PancreasGroup.Org

PancreasGroup.Org - International Pancreatic Surgery Outcomes Study

PancreasGroup.org is a collaboration of all surgeons contributing data as equal partners. Each surgeon contributing data has access to analysis files of the entire database at any time point and the right to propose analyses and publish data as long as every surgeon contributing data are included as a group author in every publication and have an opportunity to review the data prior to submission. Each collaborator has access to their own data in a form of excel export file without requiring permission or approval by the PancreasGroup.org management committee.

Postoperative complication rates classified according to Clavien-Dindo

University College London Hospitals

Massachusetts General Hospital

Royal Free Hospital NHS Foundation Trust

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Taxane

Tubulin Modulators

Antimitotic Agents

Patients receiving neoadjuvant paclitaxel 175mg/m2 and carboplatin (AUC5) at three weekly interval by intravenous route

Neoadjuvant chemotherapy

Manoj Pandey, MS, PhD

Cervical cancer represents the second commonest cancer in women worldwide, with 500,000 new cases and 300,000 deaths reported yearly. Among cervical cancer cases, 80% occur in developing countries and about 70% are identified as advanced cancer. According to the International Federation of Gynecology and Obstetrics (FIGO) staging system, a locally advanced cervical cancer includes stage IB2 to IIB.

Treatment modalities include radical surgery with or without adjuvant radiotherapy (RT), Neoadjuvant Chemotherapy (NAC) plus radical hysterectomy with or without adjuvant RT, and concomitant chemo radiation. Currently, platinum based concurrent chemoradiotherapy is the gold standard for locally advanced cervical carcinoma.

Neoadjuvant chemotherapy has many advantages: decreasing tumor size making surgery easier with improved rate of complete resection, decreased pelvic recurrence rate significantly, decreasing rate of parametrial invasion and lymph node metastasis, better brachytherapy distribution, minimal radiation toxicity, and 15% absolute increase of 5-year survival.

This study will evaluate various factors i.e. patient related (Age, Menopausal status, HPV, HIV, Comorbidities), Tumor related pathological stages (TNM), grade, lymphovascular perineural invasion, lymph nodes, extranodal extension, tumor margins including radial margin, type of tumor i.e. Adeno vs squamous, mutation profile and Treatment related factors (type of NAC, duration of NAC, no of cycles of NAC).

This is a single group prospective study to evaluate factors affecting treatment responses in uterine cervical carcinoma. All patients who will be receiving NAC followed by surgery will be included and assessed for various defined factors influencing response. Responses will be assessed by RECIST 1.1 criteria.

1. All patients of cervical growth will be evaluated. Initial clinical evaluation, biopsy and if positive, HPV DNA status will be done. On confirmation of malignancy further staging will be done by FIGO Classification. Imaging will include contrast enhanced computed tomography (CECT) abdomen or Magnetic resonance imaging (MRI) pelvis and ultrasound (USG) abdomen. Routine blood investigations, chest X-ray (CXR) and Electrocardiography (ECG) will be done.
2. In recruited patients, 3 cycles of NAC consisting of Paclitaxel (175 mg/m2) and Carboplatin (AUC5) at 21 day intervals were given.
3. Adverse reactions if any were recorded as WHO toxicity grades.
4. Evaluation of response was done after end of 2nd cycle of chemotherapy with clinical examination and Imaging (CT/MRI) by RECIST 1.1 criteria.
5. Response was divided into two groups- 1) Complete/ Partial response 2) Poor response/ Stable disease/ Progressive disease. Patients with Poor response/ stable disease/ progressive disease will undergo concurrent chemoradiation (CCRT) while patients with partial/complete response will undergo Wertheim's hysterectomy.
6. After surgery Pathological evaluation will include T, N, M, histological type, Lymphovascular invasion (LVI), Perineural invasion (PNI), Depth of Tumor Invasion, Extra nodal extension (ENE), Grade, (next generation sequencing (NGS)- Mutation Analysis.
7. Post operative external pelvic irradiation was given according to Sedlis criteria in node negative, margin negative, parametria negative cases.
8. Follow up Evaluation was done at 1, 3 \& 6 months by clinical examination, Biopsy for any recurrence and Imaging (CECT or MRI pelvis) at 6 months. Follow up was continued every 3 months thereof.

Patients with locally advanced carcinoma of the uterine cervix were recruited for assessment of clinical and pathological therapeutic response. Multivariate analysis was conducted to predict the independent predictors of response

Neoadjuvant Chemotherapy in Cervical Cancer

To Study the Factors Affecting Treatment Responses in Patients With Uterine Cervical Carcinoma Undergoing Neoadjuvant Chemotherapy

Response to intervention by RACIST criteria 1.1

Pathological response after evaluation of surgical specimen and pathological staging

Banaras Hindu University

Immune System Diseases

Nervous System Diseases

Symptoms and General Pathology

Blood and Lymph Conditions

Musculoskeletal Diseases

Autoimmune Diseases

Myasthenia Gravis

Autoimmune Diseases of the Nervous System

Hyperplasia

Thymoma

Thymus Neoplasms

Neuromuscular Junction Diseases

Thymus Hyperplasia

Muscle Weakness

Paresis

Asthenia

Muscular Diseases

Neuromuscular Manifestations

Neurologic Manifestations

Syndrome

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Nervous System Neoplasms

Neurodegenerative Diseases

Neuromuscular Diseases

Neoplasms by Histologic Type

Thoracic Neoplasms

Lymphatic Diseases

Patients with myasthenia gravis who are receiving medical treatment and treatment of crisis as plasmapheresis

Drug treatment of myasthenia gravis and treatment of crisis

Nourelhoda AA Haridy, Lecturer

Eman MH Khedr, Professor

Asmaa MM Hasan, Lecturer

This study aims to characterize the clinical features, frequency of different subgroups of MG, and identify predictors of treatment responsiveness among different subgroups of MG. The predictors are including primary outcome (percentage of changes in MG scales at baseline at time of enrollment and after 3 months) and secondary outcome (treatment-related adverse events). Also it aims to determine the frequency of patients with refractory MG.

This information will be used to understand the trends and mechanisms of disease relapse, and optimal management strategies.

Myasthenia gravis (MG) is a rare acquired autoimmune disease affecting the neuromuscular junction (NMJ), caused by autoantibodies that target the post-synaptic membrane. It's overall prevalence ranged from 150 to 250 cases per million. The most common autoantibodies are those directed to the nicotinic acetylcholine receptor (AChR), but there is smaller proportion of cases, in whom, other antibodies can be present and they included antibodies directed to muscle specific tyrosine kinase (MuSK) or to lipoprotein receptor-related protein 4 (Lrp-4). The manifestation of MG is in form of fatigable skeletal muscle weakness, affecting ocular, bulbar and limb muscles. In general, the disease diagnosis is confirmed by presence of this characteristic muscle weakness with positive autoantibodies in the serum. The main current treatment of the disease is symptomatic and immunomodulating therapies which are efficient in managing the disease manifestation. The disease prognosis is mostly favorable and about 15%, is considered medically refractory to the conventional therapy. MG can be classified into different subgroups according to different factors which included the autoantibody status, age of onset, and degree of muscle affection. These subgroups are significantly influencing the therapeutic decisions. Moreover, this proposed classification could explain the distinct immunopathological, clinical, therapeutic, and prognostic differences among these subgroups.

Current standard immunotherapies have a broad-spectrum of immune suppression, and potential side effects associated with their use can significantly impact quality of life, especially as they are usually needed life-long. Significant heterogeneity in treatment responsiveness and outcomes exists among the various subgroups of MG based on epidemiology, clinical presentation, autoantibody status, and comorbidities. In MG clinical trials, the evaluation is mainly depending on the short-term clinical efficacy, but the long-term benefits and impact on patient's quality of life and other disease burdens, (i.e., treatment-related side effects, financial impact), were not measured. The outcomes of MG were assessed in many studies and they included the reduction in quality of life, the negative impact on social and physical health, that related to the disease itself and the immunomodulators used for its treatment. Based on these factors, the investigators aimed to conduct this study to find the disease characteristics in the participants, the patient-tailored targeted treatment strategies, treatment outcomes, disease progression and quality of life.

Predictors and Prognostic Factors of Myasthenia Gravis Outcome

The MG Activities of Daily Living (MG- ADL) Scale an easily administered, 8-item questionnaire. Each item is graded on a 4- point symptom severity scale (0 = normal, 3 = most severe), with the total score ranging from 0 to 24. Test items emphasize the functional impact of muscle weakness (eg, the ability to comb one's hair or brush one's teeth instead of hand grip or outstretched arm strength tests) rather than its quantitation. The MG-ADL requires no special equipment or training and can be administered in 10 minutes. The MG-ADL test domains include ocular (2 items), oropharyngeal (3 items), respiratory (1 item), and extremity/limb (2 items).

Everyday clinical use led to the development of an abbreviated 15-item version, the MG-QOL15. These 15 items were derived from the mobility (9 items), symptoms (3 items), general contentment (1 item), and emotional well-being (2 items) domains of the 60-item version. Each of the items/statements (eg, "I have limited my social activity because of my condition") is scored by patients on a 5-point scale ranging from 0 ("not at all") to 4("very much") based on their experience over the previous 4 weeks; the item scores are summed to generate a total score ranging from 0 to 60.

The MG-MMT assesses the strength or function of 30 muscle groups typically affected by MG and includes a total of 18 items, with 12 assessed bilaterally, and 6 assessed as single items (lid closure, cheek puff, tongue protrusion, jaw closure, neck flexion, and neck extension). Each item is scored on a 5- point severity scale, based on the severity of muscle weakness \[0 = no weakness, 1 = weak/mild (25%) impairment, 2 = weak/moderate (50%) impairment, 3 = weak/severe (75%) impairment, 4 = paralyzed/unable to perform\]. Bilateral scores are summed for a total item score, and all item scores are summed for a total MG-MMT score. MG-MMT scores range from 0 to 120; domains include ocular (3 items, including eyelid closure), facial/oropharyngeal (3 items), axial strength (neck flexion/extension; 2 items), and limb strength (10 items).

The MG Composite (MGC) Scale is considered a mixed outcome measure that incorporates both physician-evaluated and patient-reported outcome items. In creating this composite scale, the developers sought to minimize the number of items (and thus administration time), to maximize the sensitivity and clinical relevance of each item, and to weight items (as recommended by the Myasthenia Gravis Foundation of America MGFA task force) commensurate with their impact on functional status, QOL, overall health status, and prognosis.13 The MGC Scale is composed of individual items from outcome measures (including the quantitative myasthenia gravis score (QMG), the MG-ADL, and the MG-MMT). Total score spans from 0 to 50.

Adverse effects of treatment of myasthenia gravis

Clinical statuses of patients are assessed and categorized according to Myasthenia Gravis Foundation of America (MGFA) postintervention status (PIS). It assesses the clinical state of MG patients at any time after institution of treatment for MG

Assiut University

Principal investigator, Lecturer of Neurology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Nasopharyngeal Carcinoma

Hypothyroidism

Neoplasms, Glandular and Epithelial

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Thyroid Diseases

All patients will receive intensity-modulated radiation therapy (IMRT) with or without adjunct chemotherapy as standard of care. They will have baseline pre-treatment and post-IMRT serum thyroid function test at least yearly after IMRT.

All patients will receive intensity-modulated radiation therapy with or without chemotherapy as usual standard of care in our institution.

Intensity-modulated radiation therapy

Victor HF Lee, MD

The investigators evaluate if there are radiation dosimetric parameters for the prediction of biochemical and clinical hypothyroidism after intensity-modulated radiation therapy (IMRT) for non-metastatic nasopharyngeal carcinoma (NPC).

Eligible patients include those with previously untreated non-metastatic nasopharyngeal carcinoma (NPC) who will receive only one course of radical IMRT with or without adjunct chemotherapy for their NPC as curative treatment. Patients who have a history of any thyroid disorders, pituitary disorders, prior thyroid surgery or a drug history of thyroxine (T4) or triiodothyronine (T3) are excluded. Patients who have a history of radiation therapy to other areas are also excluded. Pretreatment investigations and workup include serum hematology, biochemistry, antibodies against Epstein-Barr virus (EBV) viral capsid antigen (VCA) and early antigen (EA), fabrication of customized head and neck thermoplastic cast for subsequent contrast-enhanced computed tomography (CT) scan of the head and neck region down to mid-thoracic region in IMRT treatment position with 3mm thickness, as well as T1-sequence, T2-sequence and gadolinium-enhanced magnetic resonance imaging (MRI) of the head and neck region by a 3-tesla scanner with the images co-registered with the planning head and neck CT images for detailed target and organ-at-risk (OAR) delineation and IMRT planning. A separate contrast-enhanced CT scan of the thorax and abdomen will also be performed to rule out distant metastasis.

The gross tumour volumes of both the primary tumour (GTV-P) and the radiologically involved cervical nodes (GTV-N) are outlined on the planning CT images with the aid of co-registered MRI images. Subsequently clinical target volume (CTV-70) and planning target volume containing CTV-70 with a 3mm margin (PTV-70) are generated to take into account the microscopic disease spread, physiological body motions and set-up errors respectively. Another CTV-66 encompassing the high risk areas including the posterior half of the maxillary sinuses, nasal cavities, parapharyngeal spaces, styloid processes, basi-occiput, basi-sphenoid, clivus, foramina rotunda and ovale, pterygopalatine fossae, pterygomaxillary fissures, infra-orbital fissures, cavernous sinuses and level Ib and level V nodal stations is also contoured. A corresponding PTV-66 with a 3mm margin encompassing CTV-66 is created by boolean operations of the treatment planning system which is also used for IMRT optimization and planning. All OARs including brainstem, spinal cord, globes, optic nerves, optic chiasm, lenses, temporomandibular joints, temporal lobes, auditory nerves, cochleae, mandible, oral cavity, larynx, parotid glands, vestibules, pituitary and thyroid are to be contoured manually. During IMRT optimization, the maximum dose of brainstem, optic nerves and chiasm must be \<=54 Gy (allowing 0.1cc brainstem \<60 Gy) and spinal cord \<=45 Gy (allowing 0.1cc spinal cord \<48 Gy). Efforts will also made to limit mean dose of parotid glands to 26 Gy whenever possible and dose to the lenses and temporal lobes as low as reasonably achieved without compromising dose coverage to the PTVs. No dose constraint is to be given to the thyroid and pituitary during optimization of all IMRT plans.

A 7 to 9 field IMRT plan delivered by step-and-shoot technique with a 6-megavoltage linear accelerator will be generated by Eclipse Treatment Planning System. A total dose of 70 Gy and 66 Gy was prescribed to PTV-70 and PTV-66 respectively, all in 33 to 35 fractions over 6.5 to 7 weeks by simultaneous accelerated radiation therapy technique (SMART). The whole neck was irradiated with IMRT and no matching anterior field to the lower neck was noted. This has been the standard prescription and practice in our institution for the past 10 years. Positional verification with on-board imaging was performed before IMRT commencement. It was repeated again daily immediately before the first 3 fractions of IMRT and then weekly afterwards during the whole course of IMRT, to track any anteroposterior and lateral body displacements.

All patients had routine 6-site nasopharyngeal biopsies at 8 weeks after IMRT to confirm local clinical remission. Repeated nasopharyngeal biopsies were performed at 10 weeks and 12 weeks after IMRT if residual tumour cells were still observed in previous post-IMRT nasopharyngeal biopsies. Additional radiation therapy in the form of intracavitary brachytherapy, stereotactic radiation therapy or IMRT would be given if patients developed local persistence at 12 weeks after IMRT. For patients confirmed to be local clinical remission, they received regular clinical follow up and imaging surveillance every 3 to 4 months for the 1st year after IMRT, then every 4 to 6 months for the 2nd and 3rd year and yearly afterwards to monitor for any treatment-related chronic complications and relapse. Blood tests for thyroid function tests including free T4 and thyroid stimulating hormone (TSH) will be arranged at least once yearly to monitor post-IMRT hypothyroidism. Biochemical hypothyroidism is defined as either elevation of TSH above the upper normal limit or reduced free T4 below the lower normal limit or both, without the presence of clinical symptoms of hypothyroidism. Clinical hypothyroidism is defined as the presence of biochemical abnormalities of thyroid function same as that defined for biochemical hypothyroidism together with the presence of clinical symptoms of hypothyroidism. Those who are found to have clinical hypothyroidism will receive thyroxine supplement starting with 50 micrograms daily with repeated serum thyroid function tests 2 to 3 months later followed by dose titration if necessary, then every 6 to 12 months thereafter when therapeutic dosage was reached.

Univariable and multivariable binary logistic regression will be performed for dosimetric predictors of biochemical and clinical hypothyroidism. All statistical analyses will be performed by Statistical Package for Social Sciences (SPSS) and statistical significance is defined as p-value \<0.05 (two-sided).

Post-radiation Hypothyroidism After IMRT for Nasopharyngeal Carcinoma

Dosimetric Predictors of Hypothyroidism After Radical Intensity-modulated Radiation Therapy for Non-metastatic Nasopharyngeal Carcinoma

There is no plan to make individual participant data available.

Time from IMRT to development of biochemical hypothyroidism

Time from IMRT to development of clinical hypothyroidism

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tailored Interactive Intervention to Increase CRCS	NCT01084746	Colorectal Canc...	PC-based tailor... Printed educati...	50 Years - 64 Years	The University of Texas Health Science Center, Houston
International Pancreatic Surgery Outcomes Study - PancreasGroup.Org	NCT04652271	Pancreatic Neop... Pancreatitis	Pancreatic surg...	18 Years -	Royal Free Hospital NHS Foundation Trust
Neoadjuvant Chemotherapy in Cervical Cancer	NCT05384366	Cervix Cancer Cervical Cancer Cancer of the U...	Neoadjuvant che...	18 Years - 100 Years	Banaras Hindu University
Predictors and Prognostic Factors of Myasthenia Gravis Outcome	NCT05214612	Myasthenia Grav... Autoimmune Dise... Neuromuscular J... Thymoma Thymus Hyperpla... Nervous System ... Myasthenia Grav... Myasthenia Grav... Myasthenia Grav... Myasthenia Grav... Myasthenia Grav... Myasthenia Grav...	Drug treatment ...	16 Years -	Assiut University
Post-radiation Hypothyroidism After IMRT for Nasopharyngeal Carcinoma	NCT02689609	Hypothyroidism Complications	Intensity-modul...	18 Years - 80 Years	The University of Hong Kong

Spots Global Cancer Trial Database for predictors

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

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