Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Vaccines

The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.

This study assesses the safety of GSK Biologicals' Human papillomavirus (HPV) vaccine in terms of frequency and intensity of adverse events (AEs) and serious adverse events (SAEs) when administered routinely in male and female subjects aged between 9 and 25 years, according to the approved Prescribing Information in Korea.

All AEs reported during the 30-day post-vaccination follow-up period (Day 1 to Day 30) and all SAEs reported through the study period from dose 1 up to 30 days after the last dose administered during the post-marketing surveillance (PMS) were collected as part of safety data in this PMS.

Safety data collection (following routine vaccination) by a continuous surveillance method.

GSK Clinical Trials

The purpose of this post-marketing surveillance (PMS) study is to collect safety information on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at least 600 Korean women and men) within 30 days after each vaccination dose, when administered according to the approved prescribing information (PI) in Korea in a real health care setting over a period of 4 years.

A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea

Post-marketing Surveillance of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 Vaccine, Cervarix When Administered According to the Approved Prescribing Information in Korea

An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100.

An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement.

A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.

GlaxoSmithKline

Data was collected based on the Total Vaccinated Cohort.

Cervarix Group

Age, Continuous

Male

Female

Sex/Gender, Customized

Korean

Non-Korean

Race/Ethnicity, Customized

Statistical significance of AEs incidence proportion by baseline background factor wasn't planned in statistical analysis plan. As per Ministry of Food and Drug Safety regulation, additional analysis was done to determine what factors may affect AEs incidence in Korea routine clinical practice. Study design didn't include stratification or adjustment to account for baseline factors in analysis. Study findings are to be interpreted with caution considering clinical plausibility and significance.

GSK Response Center

The analysis was performed on Total Safety cohort, which included all subjects with data available at the specified time point who received at least one dose of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.

Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 1

The analysis was performed on Total Safety cohort, which included all subjects with data available at the specified time point who received two doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.

Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 2

The analysis was performed on Total Safety cohort, which included all subjects with data available at the specified time point who received three doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.

Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 3

The analysis was performed on Total Safety cohort, which included all participants with data available at the specified time point who received at least one dose of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.

Number of Participants With AEs by Maximum Intensity Post Dose 1

The analysis was performed on Total Safety cohort, which included all participants with data available at the specified time point who received two doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.

Number of Participants With AEs by Maximum Intensity Post Dose 2

The analysis was performed on Total Safety cohort, which included all participants with data available at the specified time point who received three doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.

Number of Participants With AEs by Maximum Intensity Post Dose 3

Serious Adverse Events

Fatal Serious Adverse Events

The analysis was performed on the Total Safety cohort, which included all participants who received at least one dose of vaccine as per the protocol and who reported adverse events even though they have not completed 30 days follow up period after vaccination.

Number of Participants With Serious Adverse Events (SAEs) and Fatal SAEs

Overall Study

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients with a diagnosis adenocarcinoma of the rectum will provide a tumor sample from their diagnostic biopsy and surgical procedure for research purposes, including RNA gene expression analysis. In addition to a standard MRI, patients will have an Intravoxel Incoherent Motion MRI (IVIM) and a Dynamic Contrast Enhanced MRI (DCE-MRI) for research purposes.

A tumor sample from the diagnostic biopsy and surgical procedure will be used for research.

Diagnostic Biopsy and Surgical Procedure

At the end of a standard MRI, we will perform IVIM, which is a diffusion-weighted imaging sequence that simultaneously characterizes the microscopic diffusivity of water and the macroscopic transport of water via bulk flow. IVIM may more accurately reflect the properties of the tumor microenvironment including vascular permeability, interstitial fluid pressure, and response to neoadjuvant therapy.

Intravoxel incoherent motion MRI (IVIM)

Following a standard MRI scan, Dynamic Contrast Enhanced MRI (DCE-MRI) will be done. DCE-MRI is an indicator-dilution experiment in which the delivery and transcapillary transfer of a contrast agent, typically one of a number of gadolinium-based contrast agents (GBCA), is used to assess a number of parameters characterizing tissue physiology. In locally advanced rectal cancer patients, use of DCE-MRI for determining pathologic response has produced equivocal results but more promising data has been published recently in the cervical cancer literature.

Dynamic Contrast Enhanced MRI (DCE-MRI)

RNA will be collected from biopsy and surgical tissue for gene expression analysis.

RNA gene expression analysis

Marka Crittenden, MD, PhD

This is an observational study of tumor samples and MRI imaging in patients with colorectal cancers. A tumor sample, MRI scans, and treatment outcome data will be used for research purposes to see if it is possible to predict patients' response to treatment.

The quality of the immune environment in colorectal cancer biopsy samples correlates with disease-free survival and overall survival more so than current staging conventions. This study will use a scoring system called 'immunoscore' to characterize the immune enviroment. Researchers hypothesize that the immunoscore will correlate with outcomes of colorectal patients treated with neoadjuvant chemoradiation.

Patients who enroll in the study will all undergo a biopsy as part of their standard of care evaluation. Biopsies samples will be obtained and sent to pathology for paraffin embedded blocks for diagnostic evaluation and for subsequent research. Patients will also have tissue stored in RNA later for subsequent microarray analysis.

Immunoscore in Rectal Cancer

A Study to Determine the Immunopheotype of Locally Advanced Rectal Adenocarcinoma and Its Correlation With the Efficacy of Neoadjuvant Chemoradiotherapy

This project is being done to contribute pathology samples and patient outcome data to a larger data set intended to validate an algorithm to predict patient outcome based on pathology data obtained at diagnosis. As part of this project, pre-existing samples will be used. There will be new slides made from the samples that will be stained to identify immune response. Pathology analysis and images of the slides will be provided (without patient identifiers) along with de-identified patient outcome data to a central coordinating center.

Quantitative immunohistochemical analysis will be performed on parameters of interest on both pre-treatment biopsy specimens as well as post-operative specimens. The pre-treatment sample will be used to establish the immunophenotype score. The primary analysis will evaluate the ability of immunophenotype score to correlate with pathologic response.

Oregon Health and Science University

Providence Health & Services

Symptoms and General Pathology

Body Weight

Neoplasm Metastasis

Liver Neoplasms

Colonic Diseases

Neoplastic Processes

Liver Diseases

Hematinics

Anticonvulsants

Central Nervous System Depressants

Psychotropic Drugs

Liver Extracts

Nitrazepam

Patients who are enrolled in the study will undergo an additional diffusion weighted MRI (T2W, DWI and ADC sequences) of the liver.

Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.

Diffusion Weighted MRI scan

Caroline Martin

Syvella Ellis

Pippa Hill

Lesley Wilkinson

Chris Smart

Helena Cox

Manjusha Keni

Lauren Shillito

Peng Lee

Raksha Mistry

Gemma Faulkner

Suzie Rayner

Iheoma Amaechi

Lindsay Piper

Sarah Duff

Matthew Noonan

Catriona Farrell

Julie Storer

Michelle Swann

Ravivarma Balasubramaniam

Cordelia Grant

Christos Kontovounisios

Heeam Nassa

Mark Robinson

Pritpal Klear

Holly Lawrence

Jamal Abdulkarim

Ruth Casey

Graham Branagan

Nicola Gibbons

Antony Higginson

Gina Brown

Eligible patients with high risk colorectal malignancy (T3/4, spread greater than 5mm, EMVI positive) will have additional surveillance of breath hold T1, T2 and DW-MRIs (no IV contrast) post surgery six monthly for three years.

Findings of liver MRIs as reported by radiology PI will be shared with their local MDT who make decisions as appropriate, including the management of any identified liver metastases, according to local protocol.

A phase II multicentre, interventional study to determine if additional staging at diagnosis with liver DW-MRI will diagnose more synchronous metastases than CT alone in patients with high risk colorectal cancer. Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local policy.

Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI (SERENADE)

Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI.

Proportion of additional patients diagnosed with liver metastases on DW MRI compared with CT.

% of patients diagnosed with liver metastases according to known prognostic risk factors

% lesions suspected as metastatic on DW MRI confirmed by subsequent 'gold standard' of contrast enhanced MRI and/or surgical resection, and/or progressive enlargement of the lesion.

Survival and recurrence outcomes according to presence or absence of liver metastases

Fong score of all patients with liver metastases

Proportion of patients undergoing curative treatment and methods of treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea	NCT03671369	Neoplasms, Rect...	Safety data col...	9 Years - 25 Years	GlaxoSmithKline
Immunoscore in Rectal Cancer	NCT02017509	Cancer of the R... Neoplasms, Rect... Rectal Cancer Rectal Tumors Rectal Adenocar...	Diagnostic Biop... Intravoxel inco... Dynamic Contras... RNA gene expres...	18 Years -	Providence Health & Services
Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI (SERENADE)	NCT02246634	Colorectal Neop... Neoplasm Metast... Hepatic Neoplas...	Diffusion Weigh...	16 Years -	Imperial College London
A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea	NCT03671369	Neoplasms, Rect...	Safety data col...	9 Years - 25 Years	GlaxoSmithKline

Spots Global Cancer Trial Database for neoplasms, rectal