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

• Sponsor: Institute of Cancer Research, United Kingdom (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04659252
• Collaborator: Royal Marsden NHS Foundation Trust (Other)
• Enrollment: 70
• Location: 1
• Anticipated Duration (Months): 8.9
• Patients Per Site Per Month: 7.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Other: n/a - samples collected along routine care samples only

Study Design

• Study Type: Observational
• Anticipated Enrollment: 70 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Circulating Tumour Protein Quantification From Capillary Blood for Patient Selfsampling and Safe Remote Monitoring of Multiple Myeloma During COVID-19
• Actual Study Start Date: Mar 4, 2021
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Outcome Measures

Primary Outcome Measures

1. Validated FLC [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Royal Marsden NHS Foundation Trust	Sutton		United Kingdom	SM25PT

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Kevin Boyd, Royal Marsden NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute of Cancer Research, United Kingdom
• ClinicalTrials.gov Identifier: NCT04659252
• Other Study ID Numbers: CCR5361
• First Posted: Dec 9, 2020
• Last Update Posted: Mar 11, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell

Study Results

No Results Posted as of Mar 11, 2021