Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2016-11-30
Brief Summary
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This study aims to develop innovative, more sensitive and reliable tests for better targets, in order to assess and monitor circulating cancer biomarkers. Easily accessible samples, like blood, will be tested such that invasive tissue biopsies can be avoided. Both healthy individuals and cancer patients will be recruited in this study to establish if a laboratory test is powerful enough to distinguish between individuals that may have cancer or not. Participants' involvement will also support development of novel tests to decide if a novel therapy is efficiently counteracting cancer growth or not.
Participants in the study will be asked to donate blood, sputum, urine or other body fluids, depending on the cancer and the assay being developed. After participants give their informed consent, the researchers will isolate cells, soluble factors or nucleic acids from body fluids. Researchers will then use various laboratory techniques to screen cells, soluble factors or nucleic acids for specific markers. This study looks at the effectiveness of using laboratory tests to quantify tumour markers in body fluids and, subsequently, to monitor patients' response to treatments.
Detailed Description
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After obtaining informed consent, volunteers will be asked to donate blood, urine, sputum (saliva) or other body fluids, like bronchoalveolar lavage, for our study, at the same time other analyses are carried out as part of individuals' usual medical care. If some participants are already scheduled to receive a novel drug therapy in an existing trial, we may ask them to contribute with small amount of blood, saliva, urine or other body fluids, twice, before and after the programmed treatment. Samples will be collected at the same time as participants' routine medical examinations are carried out.
Biological specimens will be collected and stored according to sample type and test specifications; then separation of cellular components and soluble factors from liquid part will be performed by research team members. Isolation techniques will vary based on the sample source.
Depending on the specific assay to be developed, protein content will be analysed by flow cytometry, enzyme-linked immunoassay (ELISA) or other immunoassays, including the beads-based Luminex® technology. In all these laboratory techniques, the unique interaction between a specific antibody and antigen enables identification of single or multiple target proteins inside a complex protein mixture.
Flow cytometry uses fluorescence properties of some dyes to evaluate the presence of specific markers on the surface or inside healthy or cancerous cells. This will help establish frequency of specific cell populations or intensity of specific markers on the cells. Likewise, ELISA allows qualitative and quantitative characterisation of soluble substances; multiple target proteins in suspension can be evaluated with Luminex® procedure within the same sample. Other biochemical techniques, such as immunoblotting can be used to determine presence/ absence of proteins located either on the cell surface of or intracellularly.
In addition to proteins, nucleic acid content can be assessed, including DNA, RNA or microRNA by biomolecular techniques.
Research data will be generated by these laboratory methods as software-specific files, such as flow cytometry standard (FCS) files for results by flow cytometry, images and data tables. Parameters like sensitivity, limit of detection and assay variability will also be evaluated and reported in numeric tables. During assay development, data from both healthy donors and cancer patients will be compared with standard statistical packages, in order to establish robust tests that can discriminate between the two groups.
Conditions
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Keywords
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Study Groups
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Healthy donors
No interventions
Venesection
Blood will be removed from the circulatory system through a cut (incision) or puncture for the purpose of analysis by qualified staff. Serum or plasma will be separated from the cellular fraction and stored for analyses.
Urine collection
Urine will be collected in appropriate sterile holders provided.
Sputum collection
Saliva will be collected in appropriate sterile holders provided.
Bronchoalveolar lavage
Bronchoscopy will be performed. Briefly, clinical care team will collect liquid after an instrument (bronchoscope) is passed through the nose or mouth into the lungs, and saline solution is squirted into a small part of the lung, then collected for analyses.
Cancer patients
No interventions
Venesection
Blood will be removed from the circulatory system through a cut (incision) or puncture for the purpose of analysis by qualified staff. Serum or plasma will be separated from the cellular fraction and stored for analyses.
Urine collection
Urine will be collected in appropriate sterile holders provided.
Sputum collection
Saliva will be collected in appropriate sterile holders provided.
Bronchoalveolar lavage
Bronchoscopy will be performed. Briefly, clinical care team will collect liquid after an instrument (bronchoscope) is passed through the nose or mouth into the lungs, and saline solution is squirted into a small part of the lung, then collected for analyses.
Interventions
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Venesection
Blood will be removed from the circulatory system through a cut (incision) or puncture for the purpose of analysis by qualified staff. Serum or plasma will be separated from the cellular fraction and stored for analyses.
Urine collection
Urine will be collected in appropriate sterile holders provided.
Sputum collection
Saliva will be collected in appropriate sterile holders provided.
Bronchoalveolar lavage
Bronchoscopy will be performed. Briefly, clinical care team will collect liquid after an instrument (bronchoscope) is passed through the nose or mouth into the lungs, and saline solution is squirted into a small part of the lung, then collected for analyses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cancer patients: age of 18 years or over; diagnosed with documented objective evidence.
Exclusion Criteria
* Cancer patients: inability to give informed consent. Suffering from severe blood coagulation disorders.
18 Years
ALL
Yes
Sponsors
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Guy's and St Thomas' NHS Foundation Trust
OTHER
Cancer Research UK
OTHER
King's College London
OTHER
Responsible Party
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Principal Investigators
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James F Spicer, FRCP, PhD
Role: PRINCIPAL_INVESTIGATOR
King's College London; Guy's & St Thomas' Hospital NHS Foundation Trust
Locations
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Guy's & St Thomas' Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Keith Brennan
Role: primary
Jennifer Boston
Role: backup
Other Identifiers
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IRAS ID 188917
Identifier Type: -
Identifier Source: org_study_id