CORONADO (Circulating tumOur pROtein quaNtification cApillary blooD cOvid-19)

March 9, 2021 updated by: Institute of Cancer Research, United Kingdom

Circulating Tumour Protein Quantification From Capillary Blood for Patient Selfsampling and Safe Remote Monitoring of Multiple Myeloma During COVID-19

The coronavirus (COVID-19) pandemic has brought severe challenges for myeloma patients. Myeloma patients are considered ultra-high risk for COVID-19 and fall into the strictest group for shielding. When on treatment, but also during times of active surveillance, patients have to regularly and frequently leave shielding and visit the hospital for blood tests to monitor their disese. This is specifically for quantification of circulating tumour protein biomarker tests for paraprotein (PP) and/or serum free light chains (sFLCs) by specialised biochemistry units.

This research aims to evaluate the potential use of an at-home patient administered technique to sample blood. The purpose of the blood sampling technique is to monitor your disease status. We want to test if it is possible to monitor a patient's disease status using this alternative blood collection method when compared to monitoring disease status using the traditional blood collection methods (venous blood sampling).

The new VAMS method is not intended to be used interchangeably or will not replace the current method. This study is to evaluate an alternative sample type that may be used to improve the patient pathway, especially during these uncertain times.

Study Overview

Status

Recruiting

Conditions

Multiple Myeloma

Intervention / Treatment

Other: n/a - samples collected along routine care samples only

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Chloe Burrows
Phone Number: 02089156773
Email: chloe.burrows@rmh.nhs.uk

Study Contact Backup

Name: Haemato-oncology Research Team
Email: HaemoncGT@rmh.nhs.uk

Study Locations

United Kingdom
- - Sutton, United Kingdom, SM25PT
    - Recruiting
    - The Royal Marsden NHS Foundation Trust
    - Contact:
      
      Chloe Burrows
      
      Email: chloe.burrows@rmh.nhs.uk
    - Principal Investigator:
      
      Kevin Boyd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Multiple myeloma patients attending routine phlebotomy clinic.

Description

Inclusion Criteria:

A diagnosis of a B-cell dyscrasia
Measurable disease by serum free light chain assay
Signed informed consent

Exclusion Criteria:

Patients <21 years of age
Cognitive impairment
Non-B Cell Dyscrasia patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validated FLC Time Frame: 6 months	Validated FLC method for use with VAMS that conforms to ISO15189:2012 accreditation	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cancer Research, United Kingdom

Collaborators

Royal Marsden NHS Foundation Trust

Investigators

Principal Investigator: Kevin Boyd, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria