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

NCT ID: NCT04659252

Last Updated: 2021-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-04

Study Completion Date

2021-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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n/a - samples collected along routine care samples only

This is a non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role collaborator

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin Boyd

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

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The Royal Marsden NHS Foundation Trust

Sutton, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Chloe Burrows

Role: CONTACT

02089156773

Haemato-oncology Research Team

Role: CONTACT

Facility Contacts

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Chloe Burrows

Role: primary

Other Identifiers

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CCR5361

Identifier Type: -

Identifier Source: org_study_id

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