Assay Development for Cancer Biomarkers

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.

Conditions

• Tumors

Interventions

PROCEDURE

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.

PROCEDURE

Urine collection

Urine will be collected in appropriate sterile holders provided.

PROCEDURE

Sputum collection

Saliva will be collected in appropriate sterile holders provided.

PROCEDURE

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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• Cancer Research UK

  collaborator OTHER

• King's College London

  lead OTHER

Principal Investigators

• James F Spicer, FRCP, PhD · King's College London; Guy's & St Thomas' Hospital NHS Foundation Trust

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-11-30

Primary Completion

2021-03-31

Countries

• United Kingdom

Study Locations