TumorsNCT02874729
Assay Development for Cancer Biomarkers
An observational study of Tumors, run by King's College London at 1 site in United Kingdom.
Trial summary
Tumour biomarkers are substances produced by cancer or by other cells of the body in response to cancer conditions. They are used to help detect, diagnose, manage and predict outcome or recurrence of some types of cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tumors
- What is being tested?
- Venesection, Urine collection and Sputum collection
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2016to Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy participants will be recruited from the general public and staff of King's College London and Guy's and St Thomas' NHS Foundation Trust, by word of mouth and email circular. Cancer patients will be recruited from outpatients, clinical areas and ward at Guy's and St Thomas' NHS Foundation Trust.
Who may be able to join
- Healthy individuals: age of 18 years or over; no history of cancer or chronic inflammatory diseases. No further screening required.
- Cancer patients: age of 18 years or over; diagnosed with documented objective evidence.
Who cannot join
- Healthy individuals: any current or previous diagnosis of cancer or chronic inflammatory diseases. Inability to give informed consent. History of blood-borne viral disease (HBV, HCV, HIV). Known or suspected anaemia. Pregnancy. Other disease that might make blood donation dangerous to the potential participant.
- Cancer patients: inability to give informed consent. Suffering from severe blood coagulation disorders.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's & St Thomas' Hospital NHS Foundation Trust
London, SE1 9RT
Keith Brennan, +44 020 7848 6391 ext. 86391, keith.brennan@kcl.ac.uk
Jennifer Boston, +44 2071885733 ext. 85733, Jennifer.Boston@gstt.nhs.uk
About this study
Official title: Development of Novel Assays to Evaluate and Measure Circulating Cancer Biomarkers
Tumour biomarkers are substances produced by cancer or by other cells of the body in response to cancer conditions. They are used to help detect, diagnose, manage and predict outcome or recurrence of some types of cancer. Tumour biomarkers can also help doctors choose the most appropriate therapy or judge if treatment is successful. Several tumour biomarkers are already used in the clinic; however, many others do not meet rigorous scientific standards to enter into clinical practice and some solid cancers can be only detected using tissue biopsy, a rather invasive procedure. Likewise, evaluating efficacy of novel therapies during clinical trials relies on adequate and specific laboratory tests. Therefore novel biomarkers and novel methods, to measure them, still represent an un-met clinical need.
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.
Read the detailed description
Potential participants will be approached by clinical or research team members and asked whether they would be interested in joining this study. Participant Information Sheet will be handled and discusses with individuals, highlighting their involvement, risk and benefit of this research. In particular, participation in the study will not alter any current therapies of the volunteers. Having left sufficient time to decide, potential participants will be asked to sign a Consent Form.
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
- Tumors
- Being tested
- Venesection, Urine collection, Sputum collection, Bronchoalveolar lavage
- Keywords
- Biomarkers, Tumor, Biological Assay
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenesectionProcedure or surgery
Also called Phlebotomy
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 collectionProcedure or surgery
Urine will be collected in appropriate sterile holders provided.
Sputum collectionProcedure or surgery
Saliva will be collected in appropriate sterile holders provided.
Bronchoalveolar lavageProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy donors | No interventions Receives: Procedure: Venesection; Procedure: Urine collection; Procedure: Sputum collection; Procedure: Bronchoalveolar lavage | |
| Cancer patients | No interventions Receives: Procedure: Venesection; Procedure: Urine collection; Procedure: Sputum collection; Procedure: Bronchoalveolar lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of assays developed
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Cancer Research UK
- Responsible party
- Sponsor
- Investigators
- James F Spicer, FRCP, PhD, Principal investigator, King's College London; Guy's & St Thomas' Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874729
- Sponsor's protocol ID
- IRAS ID 188917
- Status last verified
- Aug 2016
- First submitted
- 17 Aug 2016
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Novel Assays to Evaluate and Measure Circulating Cancer Biomarkers
- ClinicalTrials.gov ID
- NCT02874729
- Acronym / sponsor ID
- IRAS ID 188917
- Conditions
- Tumors
- Keywords
- Biomarkers, Tumor, Biological Assay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Cancer Research UK
- Study start
- Nov 2016
- Primary completion
- Mar 2021 (estimated)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tumour biomarkers are substances produced by cancer or by other cells of the body in response to cancer conditions. They are used to help detect, diagnose, manage and predict outcome or recurrence of some types of cancer. Tumour biomarkers can also help doctors choose the most appropriate therapy or judge if treatment is successful. Several tumour biomarkers are already used in the clinic; however, many others do not meet rigorous scientific standards to enter into clinical practice and some solid cancers can be only detected using tissue biopsy, a rather invasive procedure. Likewise, evaluating efficacy of novel therapies during clinical trials relies on adequate and specific laboratory tests. Therefore novel biomarkers and novel methods, to measure them, still represent an un-met clinical need.
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
Potential participants will be approached by clinical or research team members and asked whether they would be interested in joining this study. Participant Information Sheet will be handled and discusses with individuals, highlighting their involvement, risk and benefit of this research. In particular, participation in the study will not alter any current therapies of the volunteers. Having left sufficient time to decide, potential participants will be asked to sign a Consent Form.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy donors | – | Procedure: Venesection, Procedure: Urine collection, Procedure: Sputum collection, Procedure: Bronchoalveolar lavageNo interventions |
| Cancer patients | – | Procedure: Venesection, Procedure: Urine collection, Procedure: Sputum collection, Procedure: Bronchoalveolar lavageNo interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy participants will be recruited from the general public and staff of King's College London and Guy's and St Thomas' NHS Foundation Trust, by word of mouth and email circular. Cancer patients will be recruited from outpatients, clinical areas and ward at Guy's and St Thomas' NHS Foundation Trust.
Key inclusion criteria (2 listed)
- Healthy individuals: age of 18 years or over; no history of cancer or chronic inflammatory diseases. No further screening required.
- Cancer patients: age of 18 years or over; diagnosed with documented objective evidence.
Key exclusion criteria (2 listed)
- Healthy individuals: any current or previous diagnosis of cancer or chronic inflammatory diseases. Inability to give informed consent. History of blood-borne viral disease (HBV, HCV, HIV). Known or suspected anaemia. Pregnancy. Other disease that might make blood donation dangerous to the potential participant.
- Cancer patients: inability to give informed consent. Suffering from severe blood coagulation disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenesectionAlso: PhlebotomyBlood 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. | Procedure or surgery | Cancer patients, Healthy donors |
| Urine collectionUrine will be collected in appropriate sterile holders provided. | Procedure or surgery | Cancer patients, Healthy donors |
| Sputum collectionSaliva will be collected in appropriate sterile holders provided. | Procedure or surgery | Cancer patients, Healthy donors |
| Bronchoalveolar lavageBronchoscopy 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. | Procedure or surgery | Cancer patients, Healthy donors |
Primary outcome
Number of assays developed
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James F Spicer, FRCP, PhD principal investigator
King's College London; Guy's & St Thomas' Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumors, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Spicer, FRCP, PhD (+44 207 188 4260, james.spicer@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of assays developed (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2016.