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

3 februari 2015 uppdaterad av: Rebecca Robinson, The Christie NHS Foundation Trust

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.

Studieöversikt

Status

Upphängd

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Förväntat)

50

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Storbritannien
      • Manchester, Storbritannien, M20 4BX
        • The Christie NHS Foundation Trust

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patients with Lymphoma or sarcoma identified to receive out-patient chemotherapy with an anticipated febrile neutropenia rate of less than 20%.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Procedur: Biomarker and health economics
Biomarkers CK18 and FLT3 Ligand will be collected

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
sensitivity and specificity of changes in CK18 and FLT 3 ligand at day 3 of chemotherapy to predict subsequent severe toxicity
Tidsram: 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
day 3

Sekundära resultatmått

Resultatmått
Tidsram
number of hospital admissions for febrile neutropenia
Tidsram: end of chemotherapy at approximately 6 months
end of chemotherapy at approximately 6 months
Total number of overnight stays or stays in A&E of over 4 hours spent in hospital
Tidsram: End of study chemotherapy at approximately 6 months
End of study chemotherapy at approximately 6 months
Dose intensity of chemotherapy achieved compared to planned cumulative dose on initiation of therapy
Tidsram: End of chemotherapy at approximately 6 months
End of chemotherapy at approximately 6 months
Number of total days delay in receiving chemotherapy treatment compared to planned delivery
Tidsram: end of chemotherapy at approximately 6 months
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
Tidsram: cycle 2 (week6), 4 (week 12), 6 (week 18) and end of study (approximately 6 months)
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
Tidsram: end of study chemotherapy at approximately 6 months
end of study chemotherapy at approximately 6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The Christie NHS Foundation Trust

Utredare

  • Studiestol: Alastair Greystoke, The Christie NHS Foundation Trust

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2013

Primärt slutförande (Förväntat)

1 november 2015

Studieregistreringsdatum

Först inskickad

9 augusti 2013

Först inskickad som uppfyllde QC-kriterierna

12 augusti 2013

Första postat (Uppskatta)

14 augusti 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

4 februari 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 februari 2015

Senast verifierad

1 februari 2015

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 11_DOG05_99

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