Assay Development for Cancer Biomarkers
Development of Novel Assays to Evaluate and Measure Circulating Cancer Biomarkers
1 other identifier
observational
400
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2016
CompletedFirst Posted
Study publicly available on registry
August 22, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedNovember 25, 2016
August 1, 2016
4.3 years
August 17, 2016
November 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of assays developed
5 years
Study Arms (2)
Healthy donors
No interventions
Cancer patients
No interventions
Interventions
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 will be collected in appropriate sterile holders provided.
Saliva will be collected in appropriate sterile holders provided.
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King's College Londonlead
- Guy's and St Thomas' NHS Foundation Trustcollaborator
- Cancer Research UKcollaborator
Study Sites (1)
Guy's & St Thomas' Hospital NHS Foundation Trust
London, SE1 9RT, United Kingdom
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James F Spicer, FRCP, PhD
King's College London; Guy's & St Thomas' Hospital NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2016
First Posted
August 22, 2016
Study Start
November 1, 2016
Primary Completion
March 1, 2021
Last Updated
November 25, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share