title: Sequential research-related biopsies in phase I trials: acceptance, feasibility and safety.
abstract: BACKGROUND
  Sequential tumour biopsies are of potential interest for the rational development of molecular targeted therapies.
  
  
  METHODS
  From June 2004 to July 2009, 186 patients participated in 14 phase I clinical trials in which sequential tumour biopsies (13 trials) and/or sequential normal skin biopsies (6 trials) were optional. All patients had to sign an independent informed consent for the biopsies.
  
  
  RESULTS
  Tumour biopsies were proposed to 155 patients and 130 (84%) signed the consent while normal skin biopsies were proposed to 70 patients and 57 (81%) signed the consent. Tumour biopsies could not be carried out in 41 (31%) of the 130 consenting patients. Tumour biopsies were collected at baseline in 33 patients, at baseline and under treatment in 56 patients. Tumour biopsies were obtained using an 18-gauge needle, under ultrasound or computed tomography guidance. Only nine minor complications were recorded. Most tumour biopsy samples collected were intended for ancillary molecular studies including protein or gene expression analysis, comparative genomic hybridization array or DNA sequencing. According to the results available, 70% of the biopsy samples met the quality criteria of each study and were suitable for ancillary studies.
  
  
  CONCLUSIONS
  In our experience, the majority of the patients accepted skin biopsies as well as tumour biopsies. Sequential tumour and skin biopsies are feasible and safe during early-phase clinical trials, even when patients are exposed to anti-angiogenic agents. The real scientific value of such biopsies for dose selection in phase I trials has yet to be established.
authors.affiliation: Department of Medicine, SITEP.
authors.forename: C A
authors.initials: CA
authors.lastname: Gomez-Roca
authors.affiliation: Department of Biopathology.
authors.forename: L
authors.initials: L
authors.lastname: Lacroix
authors.affiliation: Department of Medicine, SITEP.
authors.forename: C
authors.initials: C
authors.lastname: Massard
authors.affiliation: Department of Medical Imaging-Interventional Radiology.
authors.forename: T
authors.initials: T
authors.lastname: De Baere
authors.affiliation: Department of Medical Imaging-Interventional Radiology.
authors.forename: F
authors.initials: F
authors.lastname: Deschamps
authors.affiliation: Department of Medical Imaging-Interventional Radiology.
authors.forename: R
authors.initials: R
authors.lastname: Pramod
authors.affiliation: Department of Medicine, SITEP.
authors.forename: R
authors.initials: R
authors.lastname: Bahleda
authors.affiliation: Department of Medicine, SITEP.
authors.forename: E
authors.initials: E
authors.lastname: Deutsch
authors.affiliation: Department of Medicine, SITEP.
authors.forename: C
authors.initials: C
authors.lastname: Bourgier
authors.affiliation: Department of Medicine, SITEP.
authors.forename: E
authors.initials: E
authors.lastname: Angevin
authors.affiliation: Department of Translational Research Laboratory.
authors.forename: V
authors.initials: V
authors.lastname: Lazar
authors.affiliation: Department of Medicine, SITEP.
authors.forename: V
authors.initials: V
authors.lastname: Ribrag
authors.affiliation: Department of Biostatistics.
authors.forename: S
authors.initials: S
authors.lastname: Koscielny
authors.affiliation: Department of Medical Imaging-Echography; Department of Medicine, Dermatology Unit.
authors.forename: L
authors.initials: L
authors.lastname: Chami
authors.affiliation: Department of Medical Imaging-Echography; Department of Medicine, Dermatology Unit.
authors.forename: N
authors.initials: N
authors.lastname: Lassau
authors.affiliation: Department of Medical Imaging-Echography; Department of Medicine, Dermatology Unit.
authors.forename: C
authors.initials: C
authors.lastname: Dromain
authors.affiliation: Department of Medical Imaging-CT-scan/MRI, Institut Gustave Roussy, Villejuif.
authors.forename: C
authors.initials: C
authors.lastname: Robert
authors.affiliation: Department of Medical Imaging-CT-scan/MRI, Institut Gustave Roussy, Villejuif.
authors.forename: E
authors.initials: E
authors.lastname: Routier
authors.affiliation: Department of Medicine, Centre Claudius Regaud, Toulouse, France.
authors.forename: J P
authors.initials: JP
authors.lastname: Armand
authors.affiliation: Department of Medicine, SITEP. Electronic address: soria@igr.fr.
authors.forename: J-C
authors.initials: JC
authors.lastname: Soria
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000465:Algorithms; D035843:Biomedical Research / Q000379:methods*; D001706:Biopsy / Q000009:adverse effects / Q000379:methods / Q000523:psychology / Q000706:statistics & numerical data; D017321:Clinical Trials, Phase I as Topic / Q000009:adverse effects* / Q000379:methods* / Q000523:psychology; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000473:pathology*; D010342:Patient Acceptance of Health Care / Q000523:psychology; D061214:Patient Safety / Q000706:statistics & numerical data; D012867:Skin / Q000473:pathology*; D055815:Young Adult