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NCT04659252 Clinical Trial

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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04659252
Other study ID # CCR5361
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 4, 2021
Est. completion date December 1, 2021

Study information
Verified date March 2021
Source Institute of Cancer Research, United Kingdom
Contact Chloe Burrows
Phone 02089156773
Email chloe.burrows@rmh.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date December 1, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: 1. A diagnosis of a B-cell dyscrasia 2. Measurable disease by serum free light chain assay 3. Signed informed consent Exclusion Criteria: 1. Patients <21 years of age 2. Cognitive impairment 3. Non-B Cell Dyscrasia patients

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• n/a - samples collected along routine care samples only
This is a non-interventional study.

Locations
Country Name City State
United Kingdom The Royal Marsden NHS Foundation Trust Sutton

Sponsors (2)
Lead Sponsor Collaborator
Institute of Cancer Research, United Kingdom Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Validated FLC Validated FLC method for use with VAMS that conforms to ISO15189:2012 accreditation 6 months
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