STUDY TITLE: BONE METASTASES FROM PROSTATE CANCER EXPERIMENTAL MODEL
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1 STUDY TITLE: BONE METASTASES FROM PROSTATE CANCER EXPERIMENTAL MODEL Updated 2011/01/11
2 Protocol study Animals: Age: Sex: Strain: Supplier: Rats 5 weeks old (upon delivery) Male Sprague Dawley Charles River Laboratories or Elevage Janvier
3 Experimental model Induction of the pathology: Injection of rat prostatic carcinoma cells (AT6-1 cells) in the medullar cavity of long bones (femora right) Arthrotomy Preparation of the medullar cavity Injection intra-osseous of AT6-1 cells
4 Experimental model Development of the pathology: The tumor is detectable 3 weeks after the cell injection (by radiography) The tumor development is mainly intra-osseous, and, some times para-osseous by the invasion of the neighbouring muscular tissues Similar lesions to cells observed in the human prostatic carcinoma pathology Osteolytic and osteoblastic lesions CT AT6-1 cells CT AT6-1 cells
5 Treatment Any administration route Treatment can be defined in accordance with the sponsor (start and frequency)
6 Clinical follow-up Weight evolution General clinical state Detailed clinical examinations Reactions after surgery and reaction to compound administration Tumor volume measurement (in case of para-osseous development)
7 Biological follow-up Dosage of serum samples by immunoenzymatic method (ELISA) in 96-well plates in duplicate Serum markers of bone resorption : CTX, TRAP 5b, Serum markers of bone formation : PAL, Osteocalcin,
8 Kinetic of radiographical analyses Radiological follow-up Scoring of radiographs: Scoring Degree of bone deformity 0 No bone metastases 1 Slight bone metastases 2 Medium bone metastases 3 High bone metastases 4 Strong bone metastases Bone metastases induced femur deformation(yellow arrow)
9 Microscanner analysis Qualitative and quantitative analysis by microtomography (Skyscan 1076) 3 dimension analysisof the sample Study of the trabecular architecture Non destructive technique (sample usable for other tests) AT6-1 cells Control
10 Histological study Animals euthanasia at the end of the study Histological studies performed on left posterior legs (femora) of each animal Per rat: Femora are embedded in paraffin after decalcification or in resin Stainings proposed: -Von Kossastaining / RESIN - Goldner s Trichrome staining / Staining -TRAP staining / PARAFFIN - Masson s Trichrome staining/ PARAFFIN - Hematoxilin/ Eosin / PARAFFIN Other stainings are available
11 SYNOPSIS Clinical follow-up twice a week Cell injection Treatment Euthanasia Delivery of animals J23 J30 J37 J44 Time (days) J-14 Quarantine J-7 J0 J7 J14 J21 J28 J35 J42 J49 Histological analysis Radiography ELISA assays Blood sampling
12 Ronan LE BOT CEO Florence DAUBINE, PhD Project Manager Contact us Fabien PETIT Project Manager Elisabeth PORCHER Business Development Manager ATLANTIC BONE SCREEN SAS 1, rue Gaston Veil Nantes France Tel : +33(0) Fax : + 33(0) And we will send you a tailor-made protocol study
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