- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
-
-
-
Manchester, Royaume-Uni, M20 4BX
- The Christie NHS Foundation Trust
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
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.
|
Biomarkers CK18 and FLT3 Ligand will be collected
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
sensitivity and specificity of changes in CK18 and FLT 3 ligand at day 3 of chemotherapy to predict subsequent severe toxicity
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
number of hospital admissions for febrile neutropenia
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: end of study chemotherapy at approximately 6 months
|
end of study chemotherapy at approximately 6 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Alastair Greystoke, The Christie NHS Foundation Trust
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 11_DOG05_99
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Biomarker and health economics
-
Brigham and Women's HospitalNational Aeronautics and Space Administration (NASA)Complété
-
Attikon HospitalDepartment of Gastroenterology, Central Clinical School, Monash UniversityComplétéSyndrome du côlon irritable avec diarrhéeGrèce
-
Children's Hospital Medical Center, CincinnatiComplété
-
University of Colorado, DenverNational Cancer Institute (NCI)RecrutementCancer pédiatrique | SurvieÉtats-Unis
-
Nantes University HospitalFondation de France; Nantes UniversitéRecrutementDéprescription | Soins palliatifs | OncologieFrance
-
University of BirminghamNational Institute for Health Research, United KingdomInconnueLa polyarthrite rhumatoïde | Maladies intestinales inflammatoires | Maladie hépatique chroniqueRoyaume-Uni
-
H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)RecrutementÉducation sur le cancer | Éducation au cancer en espagnolÉtats-Unis, Porto Rico