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

NCT04659252 | Unknown

• 1 other identifier: CCR5361
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Validated FLC

  Validated FLC method for use with VAMS that conforms to ISO15189:2012 accreditation

  6 months

Interventions

n/a - samples collected along routine care samples only OTHER

This is a non-interventional study.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple myeloma patients attending routine phlebotomy clinic.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• Royal Marsden NHS Foundation Trust: collaborator

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, SM25PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Kevin Boyd

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloe Burrows

CONTACT

02089156773; chloe.burrows@rmh.nhs.uk

Haemato-oncology Research Team

CONTACT

HaemoncGT@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 9, 2020
• Study Start: March 4, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)