- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01921998
Development of a Biomarker Directed Strategy to Ameliorate Common Toxicities From Conventional Chemotherapy (BioACT)
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Manchester, Verenigd Koninkrijk, M20 4BX
- The Christie NHS Foundation Trust
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Patients with lymphoma or sarcoma identified to receive out-patient chemotherapy with an anticipated febrile neutropenia rate of less than 20%. This would include 21 day R-CHOP in patients under 70 and single agent doxorubicin [Aapro et al, 2011a].
- Age 18 or older
- Performance Status 0-2
- Before patient registration, written informed consent must be given according to ICH/GCP, and national regulations.
Exclusion Criteria:
- Past history of HIV, Hepatitis B or C positive, due to the difficulties in handling high-risk specimens within CEP.
- Major surgery, radiotherapy, chemotherapy or mechanism based agents within the last 4 weeks.
- Radio-immunotherapy within the last 8 weeks.
- Bilirubin greater than 1.5 X the upper limit of normal and ALT greater than 2.5 x the upper limit of normal (as disturbed liver function tests are associated with elevated CK18) [Gonzalez-Quintela et al, 2009, Lavallard et al, 2011]
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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.
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Biomarkers CK18 and FLT3 Ligand will be collected
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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sensitivity and specificity of changes in CK18 and FLT 3 ligand at day 3 of chemotherapy to predict subsequent severe toxicity
Tijdsspanne: day 3
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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
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day 3
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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number of hospital admissions for febrile neutropenia
Tijdsspanne: end of chemotherapy at approximately 6 months
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end of chemotherapy at approximately 6 months
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Total number of overnight stays or stays in A&E of over 4 hours spent in hospital
Tijdsspanne: End of study chemotherapy at approximately 6 months
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End of study chemotherapy at approximately 6 months
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Dose intensity of chemotherapy achieved compared to planned cumulative dose on initiation of therapy
Tijdsspanne: End of chemotherapy at approximately 6 months
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End of chemotherapy at approximately 6 months
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Number of total days delay in receiving chemotherapy treatment compared to planned delivery
Tijdsspanne: end of chemotherapy at approximately 6 months
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end of chemotherapy at approximately 6 months
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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
Tijdsspanne: cycle 2 (week6), 4 (week 12), 6 (week 18) and end of study (approximately 6 months)
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cycle 2 (week6), 4 (week 12), 6 (week 18) and end of study (approximately 6 months)
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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
Tijdsspanne: end of study chemotherapy at approximately 6 months
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end of study chemotherapy at approximately 6 months
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Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: Alastair Greystoke, The Christie NHS Foundation Trust
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 11_DOG05_99
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