Development of a Biomarker Directed Strategy to Ameliorate Common Toxicities From Conventional Chemotherapy (BioACT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01921998|
Recruitment Status : Suspended (Trial has been suspended due to lack of resource and staff)
First Posted : August 14, 2013
Last Update Posted : February 4, 2015
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.
|Condition or disease||Intervention/treatment|
|Lymphoma Sarcoma||Procedure: Biomarker and health economics|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Development of a Biomarker Directed Strategy to Ameliorate Common Toxicities From Conventional Chemotherapy|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||November 2015|
Biomarker and health economics
Biomarkers will be taken throughout cycle 1. Health economics will be recorded using a patient side effect diary, a details of admission form, and a patient survey of healthcare use.
Procedure: Biomarker and health economics
Biomarkers CK18 and FLT3 Ligand will be collected
- sensitivity and specificity of changes in CK18 and FLT 3 ligand at day 3 of chemotherapy to predict subsequent severe toxicity [ Time Frame: day 3 ]to confirm in a prospective cohort whether changes in CK18 and FLT3 ligand at day 3 of chemotherapy can identify patients at risk of subsequent severe chemotherapy toxicity
- number of hospital admissions for febrile neutropenia [ Time Frame: end of chemotherapy at approximately 6 months ]
- Total number of overnight stays or stays in A&E of over 4 hours spent in hospital [ Time Frame: End of study chemotherapy at approximately 6 months ]
- Dose intensity of chemotherapy achieved compared to planned cumulative dose on initiation of therapy [ Time Frame: End of chemotherapy at approximately 6 months ]
- Number of total days delay in receiving chemotherapy treatment compared to planned delivery [ Time Frame: end of chemotherapy at approximately 6 months ]
- Change in QOL at the start of cycles 2, 4 and 6 of chemotherapy and at the end of study as measured by functional assessment of cancer therapy general (FACT-G) and euroqol EQ-5D questionnaires [ Time Frame: cycle 2 (week6), 4 (week 12), 6 (week 18) and end of study (approximately 6 months) ]
- Total number of contacts (both face to face and telephone) with medical and nursing staff including visits to GP, Accident and Emergency, hospital clinics and telephone consultations with Hotline staff of hospital doctors [ Time Frame: end of study chemotherapy at approximately 6 months ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921998
|The Christie NHS Foundation Trust|
|Manchester, United Kingdom, M20 4BX|
|Study Chair:||Alastair Greystoke||The Christie NHS Foundation Trust|