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Development of a Biomarker Directed Strategy to Ameliorate Common Toxicities From Conventional Chemotherapy

NCT01921998 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2015-02-04

No results posted yet for this study

Summary

Side effects from chemotherapy can be severe in some patients leading to admission to hospital, a worse quality of life and delays in subsequent doses of chemotherapy. A blood test that could predict patients who will go on to develop severe side effects could be useful and might allow early intervention with medicines to reduce the severity of the symptoms and prevent admission to hospital.

This study will collect blood samples from patients with lymphoma or sarcoma who are receiving chemotherapy (with an expected admission rate for neutropenic sepsis, one of the side effects that most commonly results in hospital admission, of less than 20%). It will assess whether changes in blood proteins ("biomarkers") taken 2 days after the 1st chemotherapy can predict subsequent severe side effects throughout the 4 months of chemotherapy. In addition the investigators will collect data on quality of life and contact with medical professionals to assess the costs of chemotherapy toxicity to both the patient and health service. This will allow us in the future to model the cost effectiveness of using biomarkers in this manner to try and reduce chemotherapy toxicity.

Conditions

Interventions

PROCEDURE

Biomarker and health economics

Biomarkers CK18 and FLT3 Ligand will be collected

Sponsors & Collaborators

  • The Christie NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Alastair Greystoke · The Christie NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-11-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01921998 on ClinicalTrials.gov