Collection of Tissue Samples for Cancer Research

Titre officiel

Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)

Sommaire:

Contexte :

• Les patients du NIH Clinical Centre ou des centres participants qui se soumettent à des évaluations ou participent à un protocole de recherche seront inscrits à celui-ci qui porte sur la sélection et la collecte de spécimens. 

 Objectifs :

• Obtenir des échantillons provenant d'examens réalisés à des fins cliniques ou dans le cadre d'autres protocoles de recherche et obtenir des échantillons provenant d'interventions non chirurgicales réalisées dans le seul but d'obtenir des échantillons pour le présent protocole, le tout à des fins de recherche.

Admissibilité :

• Patients assujettis à des évaluations ou à des traitements dans le cadre de protocoles du NIH Clinical Centre ou de centres participants.

Conception :

• Les spécimens destinés à la recherche, comme indiqué dans ce protocole, proviendront d'analyses et d'interventions réalisées dans le cadre de protocoles de recherche principaux auxquels les patients participent.
• Ces interventions et analyses peuvent comprendre, sans toutefois s'y limiter, des analyses de laboratoire de sang, de LCR, d'urine ou d'autres spécimens et des biopsies par aspiration.
•  Comme toute intervention comporte certains risques, chacune d'elle sera expliquée en détail aux patients, y compris les effets secondaires associés, avant d'obtenir un consentement distinct pour chaque intervention.
•  Les tissus et les liquides corporels à prélever peuvent comprendre, sans toutefois s'y limiter : sang, sérum, urine, tissu tumoral, tissu normal, liquide pleural, LCR, salive, liquide de lavage broncho-alvéolaire et moelle osseuse. Ces spécimens ne porteront pas l'identifiant du patient lors de leur entreposage et serviront uniquement à réaliser les études de recherche indiquées dans le présent protocole. Les patients peuvent choisir de faire don de leurs échantillons dans le but de créer des modèles précliniques pour étudier la biologie et la génétique des tumeurs et pour mettre au point de nouveaux traitements anticancéreux.

Si un patient est retiré d'une étude, il peut redonner son consentement et s'inscrire plus tard pour fournir un autre spécimen de recherche pour ce protocole.

Description de l'essai

Primary Outcome:

• Accrual ceiling met for tissue collection

Background: -Patients who are being evaluated and/or treated at the NIH Clinical Centre (pediatric and adult) and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens. Objectives:

• To obtain samples from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment.

• To obtain samples for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Eligibility: -Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and/or treated for cancer at the NIH Clinical Centre and adult patients from participating sites. Design:

• This is a multicentre tissue procurement protocol with NCI as the coordinating centre.

• For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocols to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed on adult patients at the NIH Clinical Centre for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Tissues and biological fluids to be procured may include but are not limited to blood, serum, urine, tumour tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumour cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol.

• For pediatric patients: tumour biopsy/resection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits.

• Given the risks associated with any invasive procedure, such as tumour biopsy, the procedure will be discussed in detail with the patients and their parents/guardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture.

• This study has three separate consent forms: one for adult patients at the NIH Clinical Centre to opt to donate their samples for ongoing research on assay development and studies of molecular pathways as listed in Section 8.2; and two for the generation of preclinical models (adult and pediatric). Adult patients at the NIH and participating sites, and also pediatric patients (NIH Clinical Centre only), can opt to donate specimens to create preclinical models to study tumour biology and genetics, and to develop new therapies for cancer as described in Section 8.1.

• Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.

Voir cet essai sur ClinicalTrials.gov