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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Emma Harding-Esch
info@esti2.org.uk


Dr Tariq Sadiq
ssadiq@sgul.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - Patient-consented samples for STI diagnostic & biomarker evaluation

Patient-consented samples for STI diagnostic & biomarker evaluation

Completed

Open to: Female / Male

Age: 16 Years - N/A

Medical Conditions

Infections with a predominantly sexual mode of transmission


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Testing for sexually transmitted infections (STIs) provides care for the individual, by enabling treatment which can prevent serious consequences of infection, and is also a public health intervention with the potential to reduce onward transmission of infection to sexual partners. New testing technologies, including point-of-care tests that test for a number of infections, may help overcome some of the challenges of STI prevention by enabling immediate treatment for a range of infections and improving partner notification. In addition, the discovery and evaluation of the diagnostic potential of multiple pathogen and inflammatory biomarkers ("a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention") means these can subsequently be transferred onto existing and novel diagnostic platforms.

The aim of the study is to facilitate the development and take-up of rapid, accurate, point-of-care diagnostic tests and platforms for STIs, and high quality clinical studies investigating potential biomarkers of STIs. This study will use patient-consented clinical samples, additional to routine clinical samples, to inform the development of, and conduct evaluations of, tests and biomarkers for STIs.

We will work with a number of industrial partners and different testing devices. The methods for sample and data collection for evaluations in this study will be similar. Individual contracts will be drawn up and signed for each of the industrial partners, outlining responsibilities under the Human Tissue Act. The results of the tests under evaluation will not be used to inform patient care.

This study is being conducted by eSTI2: a UKCRC-funded consortium. This study, as part of the consortium, is funded until February 2016.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

12 May 2014 31 Jan 2017

Observational

Observational type: Clinical Laboratory Study;



You can take part if:



You may not be able to take part if:


i) Patient not attending a clinic participating in an evaluation under this study ii) Patient unable to consent iii) Patient aged under 16 years Further specific exclusion criteria will be specified for each evaluation, using the Evaluations Specifics form. These could include specification of the following inclusion/exclusion criteria: • Sample characteristics: o Sample(s) type (blood/sera, vulvo-vaginal swab, vaginal swab, endocervical swab, rectal swab, urethral swab, meatal swab, ulcer swab, saliva sample, oral tissue sample, mouthwash/throat gargle, urine (first catch, mid-stream or post prostatic massage), prostatic secretion, genital skin swabs, or semen) o Samples selfor cliniciancollected o Sample media o Collection device o Date of sample collection o Sample processing o Sample adequacy o Sample volume o Organism load • Patient characteristics: o Time since last passing urine o Menstruating (for women) o Gender o Upper or lower age limits (no under 16 year olds will be included in the study) o Sexual orientation o Ethnicity o Sex abroad o Asymptomatic/symptomatic o Reason for attending clinic o Clinical symptoms o Results of any point-of-care tests (e.g. wet mount if routinely conducted, rapid HIV tests) o Clinical test results o Date and type of any recent treatment o Routinely collected risk behaviour criteria (for example, number of sexual partners in the last 3 months, and previous STI) o Test result if returning to clinic for treatment o Contact of a testpositive


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

Dr Tariq Sadiq
ssadiq@sgul.ac.uk


Dr Emma Harding-Esch
info@esti2.org.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by St. George's Hospital Medical School and funded by Medical Research Council (MRC) .




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for Trial ID: CPMS 15136

Last updated 23 March 2017

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